Acute Coronary SyndromePhase 3APPRAISE-2NCT00831441
Phase III Acute Coronary Syndrome
A Phase 3 study testing Apixaban in people with Acute Coronary Syndrome, run by Bristol-Myers Squibb at 1,012 sites in 40 countries.
Trial summary
The purpose of this study is to determine if apixaban is superior to placebo for preventing cardiovascular death, non-fatal myocardial infarction, or ischemic stroke in subjects with a recent acute coronary syndrome Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Apixaban
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7,484 participants
- Where
- 1,012 sitesin 40 countries
- Study dates
- Mar 2009to Mar 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute coronary syndrome (ACS)
- Clinically stable
- Receiving standard of care for ACS
Who cannot join
- Severe hypertension
- Active bleeding or high risk for major bleeding
- Hemoglobin < 9 g/dL
Trial locations and contacts
1,012 sites in 40 countries.
1012 sites in 40 countries
United States221 sites
Otfried N. Niedermaier, Md
Akron, Ohio, 44304
Phase Care, Llc
Alameda, California, 94501
Alexandria Cardiology Clinic
Alexandria, Louisiana, 71301
Clinical Research Network
Alexandria, Louisiana, 71301
Endeavor Medical Research, Plc
Alpena, Michigan, 49707
Orlando Heart Specialists
Altamonte Springs, Florida, 32714
Blair Medical Associates, Inc.
Altoona, Pennsylvania, 16602
Amarillo Heart Clinical Research Institute Inc.
Amarillo, Texas, 79106
Mcfarland Clinic Pc
Ames, Iowa, 50010
Cardiology Consultants Of Orange County
Anaheim, California, 92801
Anmed Health
Anderson, South Carolina, 29621
Carl Wilson Sofley, Jr., Md
Anderson, South Carolina, 29621
Local Institution
Annapolis, Maryland, 21401
Asheville Cardiology Associates
Asheville, North Carolina, 28803
Kentucky Heart & Vascular Physicians
Ashland, Kentucky, 41101
Cardiovascular Physicians Of North Atlanta
Atlanta, Georgia, 30342
Palm Beach Heart Institute, Llc
Atlantis, Florida, 33462
Medical College Of Georgia
Augusta, Georgia, 30912
Beaver Medical Group
Banning, California, 92220
City Cardiology Associates
Barberton, Ohio, 44203
Blue Stem Cardiology
Bartlesville, Oklahoma, 74006
Lowcountry Medical Group
Beaufort, South Carolina, 29906
St. Charles Health System, Inc.
Bend, Oregon, 97701
St. Lukes Cardiology Associates
Bethlehem, Pennsylvania, 18018
Uab Medical Center
Birmingham, Alabama, 35294
University Of Alabama At Birmingham
Birmingham, Alabama, 35294
Rocky Mountain Cardiology
Boulder, Colorado, 80304
Local Institution
Brick, New Jersey, 08723
New York Methodist Hospital
Brooklyn, New York, 11215
Buffalo General Hospital
Buffalo, New York, 14203
Memorial Hospital Of Carbondale
Carbondale, Illinois, 62901
The University Of North Carolina At Chapel Hill
Chapel Hill, North Carolina, 27599
The Chattanooga Heart Institute
Chattanooga, Tennessee, 37404
Bermisa Family Practice & Research Center
Chesapeake, Virginia, 23321
Northwestern University
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
University Of Chicago Hospitals
Chicago, Illinois, 60637
Local Institution
Chula Vista, California, 91911
Cincinnati Veterans Affairs Medical Center
Cincinnati, Ohio, 45220
Ronald L. Walsh, Do
Clearwater, Florida, 33756
The Heart And Vascular Institute Of Florida
Clearwater, Florida, 33756
Missouri Cardiovascular Specialists
Columbia, Missouri, 65201
Columbia Cardiology
Columbia, South Carolina, 29204
Columbus Cardiology Associates Pc
Columbus, Georgia, 31909
Georgia Heart Specialists
Covington, Georgia, 30014
Dallas Va Medical Center
Dallas, Texas, 75216
Cardiovascular Research Institute Of Dallas
Dallas, Texas, 75231
Heart Consultants Of North Texas
Dallas, Texas, 75231
Zakhary, Bosh
Danville, Virginia, 24541
Cardiovascular Specialist Of South Florida
Davie, Florida, 33324
Atlanta Institute For Medical Research, Inc
Decatur, Georgia, 30030
Henry Ford Hospital
Detroit, Michigan, 48202
Local Institution
Detroit, Michigan, 48236
In-Quest Medical Research, Llc
Duluth, Georgia, 30096
Alta Pharmaceutical Research Center, Inc.
Dunwoody, Georgia, 30338
Duke University Medical Center
Durham, North Carolina, 27710
Central Jersey Medical Research Center
Elizabeth, New Jersey, 07202
Elkhart Clinic, Llc
Elkhart, Indiana, 46514
North Georgia Medical Research
Ellijay, Georgia, 30540
Consultants In Cardiovascular Diseases, Inc.
Erie, Pennsylvania, 16502
Hamot Medical Center
Erie, Pennsylvania, 16507
Escondido Cardiology Associates, Inc.
Escondido, California, 92025
Fairfield Cardiac Cath Lab, Llc
Fairfield, Ohio, 45014
Local Institution
Fargo, North Dakota, 58122
David E. Perloff, Md
Fort Lauderdale, Florida, 33316
Sparks Regional Medical Center
Fort Smith, Arkansas, 72901
Texas Health Research & Education Institute
Fort Worth, Texas, 76104
T&R Clinic
Fort Worth, Texas, 76117
Northeast Georgia Heart Cntr, Pc
Gainesville, Georgia, 30501
Genoa Medical Center
Genoa, Ohio, 43430
The Stern Cardiovascular Center, Pa
Germantown, Tennessee, 38138
Genesys Regional Medical Center
Grand Blanc, Michigan, 48439
East Carolina Heart Institute At East Carolina University
Greenville, North Carolina, 27834
Clinical Investigation Specialists, Inc
Gurnee, Illinois, 60031
Hamilton Cardiology Associates
Hamilton, New Jersey, 08690
St Margaret Mercy Healthcare Centers
Hammond, Indiana, 46320
Hartford Hospital
Hartford, Connecticut, 06102
Local Institution
Hazard, Kentucky, 41701
William D. Bowden, D.O.
Healdsburg, California, 95448
Heart Care Associates P.C.
Hopewell, Virginia, 23860
Med Tech, Inc.
Houston, Texas, 77024
Methodist Debakey Heart & Vascular Center
Houston, Texas, 77030
Centex Research, Pineloch Medical Clinic
Houston, Texas, 77062
Heart Care Center
Houston, Texas, 77070
Northwest Houston Cardiology, Pa
Houston, Texas, 77070
California Heart Specialists, Inc.
Huntington Beach, California, 92648
Heart Center Research, Llc
Huntsville, Alabama, 35801
Krannertt Institute Of Cardiology
Indianapolis, Indiana, 46202
R. L.Roudebush Va Medical Center
Indianapolis, Indiana, 46202
The Care Group, Llc
Indianapolis, Indiana, 46260
Nature Coast Clinical Research
Inverness, Florida, 34452
University Of Mississippi Medical Center
Jackson, Mississippi, 39216
Local Institution
Jackson, Mississippi, 49201
Research Associates Of Jackson
Jackson, Tennessee, 38301
Jacksonville Heart Center, Pa
Jacksonville, Florida, 32207
Jacksonville Center For Clinical Research
Jacksonville, Florida, 32216
East Coast Institute For Research
Jacksonville, Florida, 32223
Gateway Cardiology. P.C
Jerseyville, Illinois, 62052
Mountain State Health Alliance
Johnson City, Tennessee, 37604
Richard M. Kastelic M.D. & Associates, P.C.
Johnstown, Pennsylvania, 15905
Nea Baptist Clinic
Jonesboro, Arkansas, 72401
Knoxville Heart Group
Knoxville, Tennessee, 37916
Caring Clinical Research Corporation
Laguna Hills, California, 92653
The Cardio Vascular Center P.A.
Lake Mary, Florida, 32746
Eisenstein, Isaac
Lakewood, California, 90712
The Heart Group
Lancaster, Pennsylvania, 17603
Thoracic And Cardiovascular Healthcare Foundation
Lansing, Michigan, 48910
Utah Cardiology P.C
Layton, Utah, 84041
Bryanlgh Heart Institute
Lincoln, Nebraska, 68506
Local Institution
Linden, New Jersey, 07036
South Denver Cardiology Associates Pc
Littleton, Colorado, 80120
Midwest Heart Foundation
Lombard, Illinois, 60148
Arvind J. Mehta, Md
Long Beach, California, 90806
Local Institution
Los Alamitos, California, 90720
Preciado Cardiology Incorporated
Los Angeles, California, 90033
Cardiovascular Associates, Psc
Louisville, Kentucky, 40205
Texas Cardiac Center
Lubbock, Texas, 79410
The Cardiology Group Centra.
Lynchburg, Virginia, 24501
Mercer University School Of Medicine
Macon, Georgia, 31201
Dean And St. Mary'S Outpatient Center
Madison, Wisconsin, 53715
Virginia Cardiolovascular Associates
Manassas, Virginia, 20109
Well Star Cardiovascular Medicine, Pc
Marietta, Georgia, 30060
Dr. Michael Sacher
Massapequa, New York, 11758
Alpha Medical Research, Llc
Melbourne, Florida, 32901
Melbourne Internal Medicine Associates (Mima)
Melbourne, Florida, 32901
Glenn J. Barquet, Md
Miami, Florida, 33133
Miami Cardiology Clinical Research, L.L.C.
Miami, Florida, 33156
Advanced Pharma Clinical Research
Miami, Florida, 33175
Mount Sinai Medical Center
Miami Beach, Florida, 33140
Middletown Cardiovascular Associates
Middletown, Ohio, 45044
Local Institution
Midlothian, Virginia, 23114
Wheaton Franciscan Healthcare St. Joseph
Milwaukee, Wisconsin, 53210
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Va Medical Center
Minneapolis, Minnesota, 55417
University Of Minnesota, Medical School
Minneapolis, Minnesota, 55455
Local Institution
Moline, Illinois, 61265
Local Institution
Mount Pleasant, Michigan, 48858
Medical Consultants, Pc
Muncie, Indiana, 47303
Access Clinical Trials
Nashville, Tennessee, 37203
Tulane University Hospital And Clinic
New Orleans, Louisiana, 70112
Alfieri Cardiology
Newark, Delaware, 19713
Sendara Cardiovasular Research Institute
Norfolk, Virginia, 23507
Illinois Heart & Lung Research
Normal, Illinois, 61761
Parkway Cardiology Associates, Pc
Oak Ridge, Tennessee, 37830
East Bay Physicians Medical Group
Oakland, California, 94609
Mediquest Research Group Inc.
Ocala, Florida, 34471
Ocala Research Institute, Inc
Ocala, Florida, 34471
Cor Clinical Research, Llc
Oklahoma City, Oklahoma, 73103
University Of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Oklahoma Cardiovascular Associates
Oklahoma City, Oklahoma, 73109
Heart Consultants
Omaha, Nebraska, 68114
Alegent Health Clinic Heart & Vascular Specialists
Omaha, Nebraska, 68124
St. Joseph Heritage Medical Group
Orange, California, 92868
Florida Heart Group
Orlando, Florida, 32803
Orlando Heart Center
Orlando, Florida, 32806
Midwest Cardiology Associates , P.C.
Overland Park, Kansas, 66209
Research Integrity, Llc
Owensboro, Kentucky, 42303
Palm Beach Gardens Research Center Llc
Palm Beach Gardens, Florida, 33410
Local Institution
Pembroke Pines, Florida, 33028
Cardiology Consultants
Pensacola, Florida, 32501
Heartcare Midwest
Peoria, Illinois, 61614
Drexel University College Of Medicine
Philadelphia, Pennsylvania, 19102
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Pennsylvania Cardiology Associates
Philadelphia, Pennsylvania, 19106
North Phoenix Heart Center
Phoenix, Arizona, 85020
Advent Clinical Research Centers, Inc.
Pinellas Park, Florida, 33781
Va Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, 15240
Cardio-Pulmonary Associates
Plantation, Florida, 33317
Avivo Clin Clinical Services
Port Orange, Florida, 32127
Portland Preventive Cardiology, L.L.C.
Portland, Oregon, 97225
Pottstown Medical Specialists, Inc
Pottstown, Pennsylvania, 19464
Hudson Valley Heart Center
Poughkeepsie, New York, 12601
The Miriam Hospital
Providence, Rhode Island, 02906
Wake Med Heart Center
Raleigh, North Carolina, 27610
Cardiology Assoicates, Pc/Black Hills Clinical Research Ctr
Rapid City, South Dakota, 57701
A.R.I. Clinical Trials, Inc.
Redondo Beach, California, 90277
Virgina Commonwealth Universitymedical Center
Richmond, Virginia, 23298
The Valley Hospital
Ridgewood, New Jersey, 07450
Southern Heart Research Institute, Llc
Riverdale, Georgia, 30274
Covenant Medical Center, Inc
Saginaw, Michigan, 48602
St. Augustine Cardiology Associates
Saint Augustine, Florida, 32086
St Cloud Hospital
Saint Cloud, Minnesota, 56303
Great Lakes Heart & Vascular Institute, Pc
Saint Joseph, Michigan, 49085
Delmarva Heart Research Foundation
Salisbury, Maryland, 21804
Peninsula Cardiology Associates, P.A.
Salisbury, Maryland, 21804
Central Cardiovascular Institute Of San Antonio
San Antonio, Texas, 78201
Jose A. Perez, M.D.
San Antonio, Texas, 78201
S.A.M. Clinical Research Center
San Antonio, Texas, 78229
Coastal Multi-Specialty Research
Santa Ana, California, 92704
Radiant Research, Inc
Santa Rosa, California, 95405
Heartcare Research
Sarasota, Florida, 34232
Local Institution
Scranton, Pennsylvania, 18508
Buxmont Cardiology Associates, Pc
Sellersville, Pennsylvania, 18960
Overton Brooks V.A.M.C.
Shreveport, Louisiana, 71101
Louisiana State University Health Sciences Center-Shreveport
Shreveport, Louisiana, 71103
North Central Heart Institute
Sioux Falls, South Dakota, 57108
Louisiana Heart Center
Slidell, Louisiana, 70458
Central New Jersey Cardiology
South Plainfield, New Jersey, 07080
Inland Cardiology Associates
Spokane, Washington, 99204
Washington University School Of Medicine
St Louis, Missouri, 63110
Gateway Cardiology, P.C.
St Louis, Missouri, 63128
Sugarland Cardiology Associates
Sugarland, Texas, 77479
Franciscan Research Center
Tacoma, Washington, 98405
Dr Kiran C Patel Research Institute At Pepin Heart Hospital
Tampa, Florida, 33613
Scott&White Memorial Hospital
Temple, Texas, 76508
Toledo Cardiology Consultants
Toledo, Ohio, 43608
Northwest Heart Center
Tomball, Texas, 77375
Harbbor-Ucla Medical Center
Torrance, California, 90509
William Beaumont Hospital-Troy
Troy, Michigan, 48098
Tyler Cardiovascular Consultants
Tyler, Texas, 75701
Local Institution
Valparaiso, Indiana, 46383
Howard T. Tee, M.D., F.A.C.P., F.A.C.C.
Vero Beach, Florida, 32960
Indian River Cardiovascular Associates, Inc
Vero Beach, Florida, 32960
Cardiology Partners Clinical Research Institute
Wellington, Florida, 33449
Iowa Heart Center
West Des Moines, Iowa, 50266
Drogue Medical, Llc
Wheat Ridge, Colorado, 80033
Wilmington Medical Research
Wilmington, North Carolina, 28401
Azalea Research Center
Wilmington, North Carolina, 28403
Moffit Heart & Vascular Group
Wormleysburg, Pennsylvania, 17043
Local Institution
Youngstown, Ohio, 44501
Cardiology Associates Of Southeastern Ohio
Zanesville, Ohio, 43701
Russia71 sites
Local Institution
Barnaul, 656055
Local Institution
Chelyabinsk, 454136
Local Institution
Kaluga, 248007
Local Institution
Kazan', 420029
Local Institution
Kemerovo, 650002
Local Institution
Krasnoyarsk, 660058
Local Institution
Krasnoyarsk, 660062
Local Institution
Moscow, 105229
Local Institution
Moscow, 109240
Local Institution
Moscow, 111539
Local Institution
Moscow, 115093
Local Institution
Moscow, 115280
Local Institution
Moscow, 117292
Local Institution
Moscow, 117593
Local Institution
Moscow, 119048
Local Institution
Moscow, 119620
Local Institution
Moscow, 119991
Local Institution
Moscow, 121359
Local Institution
Moscow, 121374
Local Institution
Moscow, 121552
Local Institution
Moscow, 123182
Local Institution
Moscow, 125206
Local Institution
Moscow, 125284
Local Institution
Moscow, 125424
Local Institution
Moscow, 127018
Local Institution
Moscow, 127473
Local Institution
Moscow, 127644
Local Institution
Moscow, 129301
Local Institution
Moscow, 129327
Local Institution
Moscow, 129336
Local Institution
Moscow, 19991
Local Institution
Moscow Reg. Zhekeznodorozhniy, 143920
Local Institution
Nizhny Novgorod, 603003
Local Institution
Nizhny Novgorod, 603005
Local Institution
Nizhny Novgorod, 603035
Local Institution
Novosibirsk, 630003
Local Institution
Novosibirsk, 630008
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Novosibirsk, 630047
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Novosibirsk, 630089
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Odintsovo, 143000
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Penza, 440026
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Perm, 614036
Local Institution
Rostov-on-Don, 344011
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Ryazan, 390026
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Saint Petersburg, 190000
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Saint Petersburg, 191104
Local Institution
Saint Petersburg, 192242
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Saint Petersburg, 193079
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Saint Petersburg, 193144
Local Institution
Saint Petersburg, 193312
Local Institution
Saint Petersburg, 194156
Local Institution
Saint Petersburg, 194291
Local Institution
Saint Petersburg, 195067
Local Institution
Saint Petersburg, 196601
Local Institution
Saint Petersburg, 197110
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Saint Petersburg, 198013
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Saint Petersburg, 198205
Local Institution
Saratov, 410028
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Saratov, 410054
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Tomsk, 634012
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Tver', 170036
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Tyumen, 625023
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Vasilievsky Island, 199106
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Voronezh, 394065
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Yaroslavl, 150002
Local Institution
Yaroslavl, 150003
Local Institution
Yaroslavl, 150030
Local Institution
Yaroslavl, 150062
Local Institution
Yekaterinburg, 620109
Local Institution
Yekaterinburg, 620144
Local Institution
Zhukovskiy, 140180
Brazil53 sites
Local Institution
Belém, Pará, 66087
Local Institution
Belo Horizonte, Minas Gerais, 30110
Local Institution
Belo Horzonte, Minas Gerais, 30150
Local Institution
Blumenau, Santa Catarina, 89010
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Brasília, Federal District, 70335
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Brasília, Federal District, 70390
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Brasília, Federal District, 70658
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Brasília, Federal District, 72115
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Campinas, São Paulo, 13059
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Curitiba, Paraná, 80010
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Curitiba, Paraná, 80320
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Curitiba, Paraná, 80730
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Goiânia, Goiás, 74809
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Goiânia, Goiás, 74823
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Juiz de Fora, Mato Grosso, 36021
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Limeira, São Paulo, 13480
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Londrina, Paraná, 86010
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Maceió, Alagoas, 57051
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Marília, São Paulo, 17515
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Marília, São Paulo, 17519
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Natal, Rio Grande do Norte, 59020
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Passo Fundo, Rio Grande do Sul, 99010
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Porto Alegre, Rio Grande do Sul, 90020
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Porto Alegre, Rio Grande do Sul, 90035
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Porto Alegre, Rio Grande do Sul, 90110
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Porto Alegre, Rio Grande do Sul, 90610
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Porto Alegre, Rio Grande do Sul, 90620
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Porto Alegre, Rio Grande do Sul, 91350
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Recife, Pernambuco, 50100
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Rio de Janeiro, Rio de Janeiro, 22031
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Rio de Janeiro, Rio de Janeiro, 22240
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Rio de Janeiro, Rio de Janeiro, 22261
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Rio Janeiro, Rio de Janeiro, 22280
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Salvador, Estado de Bahia, 40144
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Salvador, Estado de Bahia, 40323
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Salvador, Estado de Bahia, 41148
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Salvador, Estado de Bahia, 41810
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Santo André, São Paulo, 09020
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Santo André, São Paulo, 09190
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São Caetano do Sul, São Paulo, 09540
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São José, Santa Catarina, 88103
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São José do Rio Preto, São Paulo, 15015
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São José do Rio Preto, São Paulo, 15090
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São Paulo, São Paulo, 01323
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São Paulo, São Paulo, 01506
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São Paulo, São Paulo, 02276
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São Paulo, São Paulo, 04012
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São Paulo, São Paulo, 04023
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São Paulo, São Paulo, 05403
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São Paulo, São Paulo, 05508
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Sobral, Ceará, 62041
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Uberlândia, Minas Gerais, 384000-368
Local Institution
Uberlândia, Minas Gerais, 38400
Japan49 sites
Local Institution
Ageo, Saitama, 362-8588
Local Institution
Beppu, Oita Prefecture, 874-0011
Local Institution
Chiyoda-Ku, Tokyo, 101-8643
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Chuo-Ku, Tokyo, 1048560
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Fukuoka, Fukuoka, 814-0180
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Gifu, Gifu, 5008513
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Gifu, Gifu, 5008727
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Hachiōji, Tokyo, 1930998
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Iwakuni, Yamaguchi, 7408510
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Kanazawa, Ishikawa-ken, 9200007
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Kanoya, Kagoshima-ken, 8930015
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Kasama, Ibaraki, 309-1793
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Kasuga, Fukuoka, 816-0864
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Kochi, Kochi, 7808522
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Komatsushimachō, Tokushima, 7738502
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Koshigaya, Saitama, 3438555
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Kumamoto, Kumamoto, 8600008
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Kumamoto, Kumamoto, 8608556
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Kumamoto, Kumamoto, 861-4193
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Kumamoto, Kumamoto, 862-0965
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Kure, Hiroshima, 737-0023
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Kurume, Fukuoka, 830-8577
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Kyoto, Kyoto, 6158087
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Matsudo, Chiba, 2710077
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Meguro City, Tokyo, 153-8515
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Meguro-Ku, Tokyo, 1528902
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Nagoya, Aichi-ken, 4538511
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Nagoya, Aichi-ken, 455-8530
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Nagoya, Aichi-ken, 4600001
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Nagoya, Aichi-ken, 4668650
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Obihiro, Hokkaido, 0808518
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Ogaki-Shi, Gifu, 503-8502
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Ōita, Oita Prefecture, 870-0263
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Osaka, Osaka, 558-8558
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Saga, Saga-ken, 840-8571
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Sakai, Osaka, 591-8025
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Sapporo, Hokkaido, 0630005
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Seto-Shi, Aichi-ken, 4898642
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Toda, Saitama, 3350023
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Tokyo, Tokyo, 1600023
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Tsuchiura-Shi, Ibaraki, 300-0053
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Tsukuba, Ibaraki, 3058558
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Ube, Yamaguchi, 7558505
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Ueda, Nagano, 386-8610
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Ureshino, Saga-ken, 8430393
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Yokohama, Kanagawa, 232-0024
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Yokohama, Kanagawa, 234-8503
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Yokohama Sakae-Ku, Kanagawa, 247-8581
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Yokosuka, Kanagawa, 2388567
Argentina42 sites
Local Institution
Berazategui, Buenos Aires, B1884KZB
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Buenos Aires, Buenos Aires, 1039
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Buenos Aires, Buenos Aires, 1119
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Buenos Aires, Buenos Aires, 1122
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Buenos Aires, Buenos Aires, 1280
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Buenos Aires, Buenos Aires, 1428
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Capital, Mendoza Province, 5500
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Capital Federal, Buenos Aires, 1155
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Cipolletti, Río Negro Province, 8324
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Ciudad Autonoma Buenos Aires, Buenos Aires, 1180
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Ciudad Autonoma de Beunos Aire, Buenos Aires, 1431
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Córdoba, Córdoba Province, 5000
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Córdoba, Córdoba Province, 5002
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Córdoba, Córdoba Province, 5006
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Córdoba, Córdoba Province, X5004CDT
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Coronel Suárez, Buenos Aires, 7540
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Corrientes, Corrientes Province, 3400
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Corrientes Capital, Corrientes Province, 3400
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Gaba, Buenos Aires, 1437
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Haedo, Buenos Aires, B1706AJU
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Junín, Buenos Aires, 6000
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La Plata, Buenos Aires, B1902COS
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Lanús Oeste, Buenos Aires, 1824
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Morón, Buenos Aires, 1708
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Posadas, Misiones Province, 3300
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Quilmes, Buenos Aires, B1878DKF
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Ramos Mejía, Buenos Aires, B1704ETD
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Resistencia, Chaco Province, 3500
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Rosario, Santa Fe Province, 2000
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Rosario, Santa Fe Province, 2002
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Salta, Salta Province, A4400ANG
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San Isidro, Buenos Aires, 1642
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San Luis, San Luis Province, D5702JRS
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San Martín, Buenos Aires, B1650CSQ
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San Miguel de Tucumán, Tucumán Province, 4000
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San Miguel de Tucumán, Tucumán Province, T4000ICL
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San Salvador de Jujuy, Jujuy Province, Y4600ABF
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Santa Fe, Santa Fe Province, 3000
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Santa Fe, Santa Fe Province, S3000AZG
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Villa Cabrera, Córdoba Province, 5009
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Villa Carlos Paz, Córdoba Province, 5152
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Villa María, Córdoba Province, 5900
China42 sites
Local Institution
Beijing, Beijing Municipality, 100020
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Beijing, Beijing Municipality, 100029
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Beijing, Beijing Municipality, 100034
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Beijing, Beijing Municipality, 100038
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Beijing, Beijing Municipality, 100044
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Beijing, Beijing Municipality, 100088
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Beijing, Beijing Municipality, 100176
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Beijing, Beijing Municipality, 100730
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Beijing, Shanghai Municipality, 100037
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Changchun, Jilin, 130021
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Changchun, Jilin, 130041
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Changsha, Hunan, 410005
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Chengdu, Sichuan, 610041
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Chongqing, Chongqing Municipality, 400042
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Chongqing, Sichuan, 400010
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Dalian, Liaoning, 116023
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Guangzhou, Guangdong, 510010
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Guangzhou, Guangdong, 510080
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Guangzhou, Guangdong, 510120
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Guangzhou, Guangdong, 510180
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Hangzhou, Zhejiang, 310009
Local Institution
Hangzhou, Zhejiang, 310016
Local Institution
Harbin, Heilongjiang, 150001
Local Institution
Jinan, Shandong, 250012
Local Institution
Kunming, Yunnan, 650101
Local Institution
Lanzhou, Gansu, 730030
Local Institution
Nanchang, Jiangxi, 330006
Local Institution
Nanjing, Jiangsu, 210008
Local Institution
Nanjing, Jiangsu, 210009
Local Institution
Nanjing, Jiangsu, 210029
Local Institution
Nanning, Guangxi, 530021
Local Institution
Shanghai, Shanghai Municipality, 200003
Local Institution
Shanghai, Shanghai Municipality, 200065
Local Institution
Shanghai, Shanghai Municipality, 200072
Local Institution
Shenyang, Liaoning, 110001
Local Institution
Shenyang, Liaoning, 110004
Local Institution
Shenyang, Liaoning, 110016
Local Institution
Shijiazhuang, Hebei, 710061
Local Institution
Suzhou, Jiangsu, 215004
Local Institution
Suzhou, Jiangsu, 215006
Local Institution
Wuhan, Hubei, 430060
Local Institution
Xi'an, 710061
Canada37 sites
Local Institution
Cambridge, Ontario, N1R 6V6
Local Institution
Cambridge, Ontario, N1R 7R1
Local Institution
Chiccutimi, Quebec, G7H 5H6
Local Institution
Edmonton, Alberta, T5H 3V9
Local Institution
Edmonton, Alberta, T6G 2B7
Local Institution
Edmonton, Alberta, T6K 4C1
Local Institution
Greater Sudbury, Ontario, P3C 5K7
Local Institution
Greater Sudbury, Ontario, P3E 2N8
Local Institution
Greater Sudbury, Ontario, P3E 3B8
Local Institution
Grimsby, Ontario, L3M 1P3
Local Institution
Halifax, Nova Scotia, B3H 3A7
Local Institution
Kitchener, Ontario, N2M 1B2
Local Institution
Lévis, Quebec, G6V 3Z1
Local Institution
London, Ontario, N6A 5A5
Local Institution
Montreal, Quebec, H3A 1A1
Local Institution
New Westminster, British Columbia, V3L 3W5
Local Institution
Oshawa, Ontario, L1H 1B9
Local Institution
Oshawa, Ontario, L1H 7K4
Local Institution
Oshawa, Ontario, L1J2K1
Local Institution
Parry Sound, Ontario, P2A 3A4
Local Institution
Penticton, British Columbia, V2A 3G6
Local Institution
Saint-Charles-Borromée, Quebec, J6E 6J2
Local Institution
Saint-Jérôme, Quebec, J7Z 5T3
Local Institution
Sarnia, Ontario, N7T 4R9
Local Institution
Scarborough Village, Ontario, M1E 4B9
Local Institution
Scarborough Village, Ontario, M1P 2T7
Local Institution
Sorel-Tracy, Quebec, J3P1N5
Local Institution
St-Foy, Quebec, G1V 4G5
Local Institution
St. John's, Newfoundland and Labrador, A1B 3V6
Local Institution
Sydney, Nova Scotia, B1P 1P3
Local Institution
Terrebonne, Quebec, J6V 2H2
Local Institution
Toronto, Ontario, M4C 3E7
Local Institution
Toronto, Ontario, M5B 1W8
Local Institution
Toronto, Ontario, M5G 2C4
Local Institution
Victoria, British Columbia, V8R 4R2
Local Institution
Windsor, Ontario, N8X 1L9
Local Institution
Winnipeg, Manitoba, R3K 0Y8
Poland34 sites
Local Institution
Bialystok, 15-276
Local Institution
Bydgoszcz, 85-826
Local Institution
Bytom, 41-902
Local Institution
Częstochowa, 42-200
Local Institution
Elblag, 82-300
Local Institution
Gdynia, 81-423
Local Institution
Grodzisk Mazowiecki, 05-825
Local Institution
Inowrocław, 88-100
Local Institution
Kielce, 25-736
Local Institution
Kościerzyna, 83-400
Local Institution
Krakow, 31-202
Local Institution
Krakow, 31-501
Local Institution
Lodz, 91-347
Local Institution
Lodz, 91-425
Local Institution
Lublin, 20-089
Local Institution
Lublin, 20-954
Local Institution
Opole, 45-418
Local Institution
Ostrowiec Świętokrzyski, 27-400
Local Institution
Płock, 09-402
Local Institution
Poznan, 60-479
Local Institution
Radom, 26617
Local Institution
Rzeszów, 35-301
Local Institution
Słupsk, 76-200
Local Institution
Szczecin, 70-111
Local Institution
Tarnów, 33-100
Local Institution
Torun, 87-100
Local Institution
Warsaw, 01-809
Local Institution
Warsaw, 02-507
Local Institution
Warsaw, 04-628
Local Institution
Warsaw, 04-749
Local Institution
Węgrów, Mazowiekie, 07-100
Local Institution
Włocławek, 87-800
Local Institution
Zabrze, 41-800
Local Institution
Zielona Góra, 65-046
India33 sites
Local Institution
Ahmedabad, Gujarat, 380006
Local Institution
Ahmedabad, Gujarat, 380014
Local Institution
Ahmedabad, Gujarat, 380015
Local Institution
Bangalore, Karnataka, 560 099
Local Institution
Bangalore, Karnataka, 560054
Local Institution
Bangalore, Karnataka, 560034
Local Institution
Bikaner, 334001
Local Institution
Chennai, Tamil Nadu, 600081
Local Institution
Coimbatore, Tamil Nadu, 641037
Local Institution
Gurgaon, Haryana, 122001
Local Institution
Hyderabad, Andhra Pradesh, 500-012
Local Institution
Hyderabad, Andhra Pradesh, 500063
Local Institution
Indore, Madhya Pradesh, 452008
Local Institution
Jaipur, Rajasthan, 302001
Local Institution
Jaipur, Rajasthan, 302004
Local Institution
Jaipur, Rajasthan, 302017
Local Institution
Jalandhar, Punjab, 144008
Local Institution
Lucknow, Uttar Pradesh, 226003
Local Institution
Mangalore, 575003
Local Institution
Mumbai, Maharashtra, 400007
Local Institution
Mumbai, Maharashtra, 400050
Local Institution
Mysore, Karnataka, 570020
Local Institution
Nagpur, Maharashtra, 440010
Local Institution
Nagpur, Maharashtra, 440012
Local Institution
Nagpur, Maharashtra, 440033
Local Institution
New Delhi, 110025
Local Institution
New Delhi, 110060
Local Institution
Pune, Maharashtra, 411001
Local Institution
Pune, Maharashtra, 411004
Local Institution
Pune, 411004
Local Institution
Shivamogga, Karnataka, 577201
Local Institution
Vadodara, Gujarat, 390007
Local Institution
Vijayawada, Andhra Pradesh, 520008
Germany32 sites
Local Institution
Bad Berka, 99437
Local Institution
Bad Nauheim, 61231
Local Institution
Berlin, 12351
Local Institution
Berlin, 12559
Local Institution
Berlin, 13509
Local Institution
Berlin, 13585
Local Institution
Bernau, 16321
Local Institution
Bonn, 53105
Local Institution
Bonn, 53115
Local Institution
Chemnitz, 09111
Local Institution
Coswig, 06869
Local Institution
Cottbus, 03048
Local Institution
Dachau, 85221
Local Institution
Essen, 45122
Local Institution
Flensburg, 24939
Local Institution
Halle, 06120
Local Institution
Hamburg, 20099
Local Institution
Hamburg, 21075
Local Institution
Hamburg, 22763
Local Institution
Hoyerswerda, 02977
Local Institution
Jena, 07747
Local Institution
Leverkusen, 51375
Local Institution
Limburg, 65549
Local Institution
Lübeck, 23538
Local Institution
Mainz, 55131
Local Institution
Münster, 48149
Local Institution
Neuss, 41464
Local Institution
Paderborn, 33098
Local Institution
Pirna, 01796
Local Institution
Regensburg, 93053
Local Institution
Rostock, 18057
Local Institution
Wesel, 46483
Mexico26 sites
Local Institution
Acapulco de Juárez, Guerrero, 39570
Local Institution
Acapulco de Juárez, Guerrero, 39670
Local Institution
Aguascalientes, Aguascalientes, 20127
Local Institution
Aguascalientes, Aguascalientes, 20230
Local Institution
Cabo San Lucas, Baja Californa Sur, 23410
Local Institution
Chihuahua City, Chihuahua, 31203
Local Institution
Culiacán, Sinaloa, 80020
Local Institution
Durango, Durango, 34270
Local Institution
Guadalajara, Jalisco, 44200
Local Institution
Guadalajara, Jalisco, 44210
Local Institution
Guadalajara, Jalisco, 44280
Local Institution
Metepec, State of Mexico, 52140
Local Institution
Monclova, Coahuila, 25750
Local Institution
Monterrey, Nuevo León, 64000
Local Institution
Monterrey, Nuevo León, 64060
Local Institution
Monterrey, Nuevo León, 64460
Local Institution
Monterrey, Nuevo León, 64550
Local Institution
Monterrey, Nuevo León, 64710
Local Institution
Pachuca, Hidalgo, 42070
Local Institution
Querétaro City, Querétaro, 76000
Local Institution
San Luis Potosí City, San Luis Potosí, 78240
Local Institution
Tijuana, Estado de Baja California, 22500
Local Institution
Tlalnepantla, State of Mexico, 54030
Local Institution
Veracruz, Veracruz, 91700
Local Institution
Xalapa, Veracruz, 91190
Local Institution
Zapopan, Jalisco, 45040
Spain26 sites
Local Institution
Almería, Almeria, 04120
Local Institution
Barcelona, 08003
Local Institution
Barcelona, 08035
Local Institution
Cáceres, Caceres, 10003
Local Institution
El Ejido, 04700
Local Institution
Figueres, Gerona, 17600
Local Institution
Granada, 18014
Local Institution
Lleida, 25198
Local Institution
Lugo, 27004
Local Institution
Madrid, Madrid, 28007
Local Institution
Madrid, Madrid, 28031
Local Institution
Madrid, Madrid, 28041
Local Institution
Madrid, 28006
Local Institution
Madrid, 28046
Local Institution
Madrid, 28050
Local Institution
Málaga, 29010
Local Institution
Oviedo, Asturas, 33006
Local Institution
San Sebastián de los Reyes, Madrid, 28702
Local Institution
Santiago de Compostela, Santiago de Compostela, 15706
Local Institution
Seville, 41071
Local Institution
Tarragona, 43007
Local Institution
Torrevieja, 03186
Local Institution
Valencia, 46014
Local Institution
Valladolid, 47012
Local Institution
Villajoyosa, Alicante, 03570
Local Institution
Zaragoza, 50009
Ukraine26 sites
Local Institution
Chernivtsy, 58013
Local Institution
Dnipropetrovsk, 49006
Local Institution
Dnipropetrovsk, 49060
Local Institution
Donetsk, 83003
Local Institution
Donetsk, 83045
Local Institution
Donetsk, 83114
Local Institution
Ivano-Frankivsk, 76025
Local Institution
Kharkiv, 61002
Local Institution
Kharkiv, 61018
Local Institution
Kharkiv, 61039
Local Institution
Kharkiv, 61115
Local Institution
Kharkiv, 61176
Local Institution
Kyiv, 02091
Local Institution
Kyiv, 02660
Local Institution
Kyiv, 03115
Local Institution
Kyiv, 03151
Local Institution
Luhansk, 91016
Local Institution
Lutsk, 43024
Local Institution
Lviv, 79010
Local Institution
Lviv, 79015
Local Institution
Mykolayiv, 54003
Local Institution
Odesa, 65014
Local Institution
Odesa, 65059
Local Institution
Simferopol, 95026
Local Institution
Vinnitsa, 21029
Local Institution
Zhaporizhzhya, 69000
Hungary23 sites
Local Institution
Baja, 6500
Local Institution
Balatonfüred, 8230
Local Institution
Budapest, 1027
Local Institution
Budapest, 1032
Local Institution
Budapest, 1041
Local Institution
Budapest, 1085
Local Institution
Budapest, 1096
Local Institution
Budapest, 1097
Local Institution
Budapest, 1106
Local Institution
Budapest, 1145
Local Institution
Budpest, 1122
Local Institution
Cegléd, 2700
Local Institution
Debrecen, 4032
Local Institution
Dunaújváros, 2400
Local Institution
Hódmezővásárhely, 6800
Local Institution
Kecskemét, 6000
Local Institution
Miskolc, 3526
Local Institution
Miskolc, 3529
Local Institution
Székesfehérvár, 8000
Local Institution
Szekszárd, 7100
Local Institution
Szentes, 6600
Local Institution
Szombathely, 9700
Local Institution
Zalaegerszeg, 8900
Israel19 sites
Local Institution
Afula, 18101
Local Institution
Ashkelon, 78306
Local Institution
Hadera, 38100
Local Institution
Haifa, 31048
Local Institution
Haifa, 31096
Local Institution
Haifa, 34362
Local Institution
Jerusalem, 91004
Local Institution
Jerusalem, 91031
Local Institution
Jerusalem, 91120
Local Institution
Jerusalem, 91240
Local Institution
Kfar Saba, 44281
Local Institution
Nahariya, 22100
Local Institution
Nazareth, 16000
Local Institution
Nazareth, 16100
Local Institution
Petah Tikva, 49100
Local Institution
Rehovot, 76100
Local Institution
Safed, 13100
Local Institution
Tel Aviv, 64239
Local Institution
Tiberias, 15208
Netherlands19 sites
Local Institution
Alkmaar, 1815 JD
Local Institution
Almere Stad, 1315 RA
Local Institution
Amsterdam, 1091 AC
Local Institution
Beverwijk, 1942 LE
Local Institution
Boxmeer, 5831 HA
Local Institution
Dirksland, 3247 BW
Local Institution
Ede, 6916 RP
Local Institution
Goes, 4462 RA
Local Institution
Gouda, 2803 HH
Local Institution
Heerlen, 6419 PC
Local Institution
Hilversum, 1213 XZ
Local Institution
Maastrict, 6229 HX
Local Institution
Meppel, 7943KA
Local Institution
Purmerend, 1441 RN
Local Institution
Sneek, 8601 ZK
Local Institution
The Hague, 2597 AX
Local Institution
Veldhoven, 5504 DB
Local Institution
Weert, 6001 BE
Local Institution
Zwolle, 8011JW
United Kingdom19 sites
Local Institution
Ayr, Ayrshire, KA6 6DX
Local Institution
Basildon, Essex, SS16 5NL
Local Institution
Belfast, Antrim, BT9 7AB
Local Institution
Belfast, Armagh, BT12 6BA
Local Institution
Blackpool, Lancashire, FY3 8NR
Local Institution
Cambridge, Cambridgeshire, CB2 0QQ
Local Institution
Chelmsford, Essex, CM1 7ET
Local Institution
Chesterfield, Derbyshire, S445BL
Local Institution
Cottingham, East Yorkshire, HU16 5JQ
Local Institution
Doncaster, South Yorkshire, DN2 5LT
Local Institution
Dumfries, Dumfriesshire, DG1 4AP
Local Institution
Harrow, Middlesex, HA1 3UJ
Local Institution
Kilmarnock, Ayrshire, KA2 0BE
Local Institution
New Castle Upon Tyne, Tyne and Wear, NE7 7DN
Local Institution
Portadown, Armagh, BT63 5QQ
Local Institution
Romford, Essex, RM7 0AG
Local Institution
Royal Tunbridge Wells, Kent, TN4 8AT
Local Institution
Scunthorpe, Lincolnshire, DN15 7BH
Local Institution
Worksop, Nottinghamshire, S18 0BD
Bulgaria17 sites
Local Institution
Burgas, 8000
Local Institution
Dimitrovgrad, 6400
Local Institution
Pazardzhik, 4400
Local Institution
Pleven, 5800
Local Institution
Plovdiv, 4000
Local Institution
Plovdiv, 4002
Local Institution
Sofia, 1142
Local Institution
Sofia, 1202
Local Institution
Sofia, 1233
Local Institution
Sofia, 1309
Local Institution
Sofia, 1407
Local Institution
Sofia, 1431
Local Institution
Sofia, 1527
Local Institution
Sofia, 1606
Local Institution
Sofia, 1618
Local Institution
Stara Zagora, 6003
Local Institution
Varna, 9010
Italy17 sites
Local Institution
Ascoli Piceno, 63100
Local Institution
Bergamo, 24128
Local Institution
Chieti, 66013
Local Institution
Foggia, 71100
Local Institution
Gravedona (Co), 22015
Local Institution
Grosseto, 58100
Local Institution
Massa, 54100
Local Institution
Milan, 20138
Local Institution
Milan, 20132
Local Institution
Naples, 80131
Local Institution
Novara, 28100
Local Institution
Pavia, 27100
Local Institution
Perugia, 06126
Local Institution
Roma, 00184
Local Institution
San Daniele Del Friuli (Udine), 33038
Local Institution
Saronno (Va), 21047
Local Institution
Verona, 37126
South Africa16 sites
Local Institution
Bellville, Western Cape, 7530
Local Institution
Bloemfontein, Free State, 9300
Local Institution
Bloemfontein, Free State, 9301
Local Institution
Centurion, Gauteng, 0157
Local Institution
Durban, KwaZulu-Natal, 4001
Local Institution
Durban, KwaZulu-Natal, 4091
Local Institution
Durban, KwaZulu-Natal, 4092
Local Institution
Johannesburg, 2013
Local Institution
Kuils River, Western Cape, 7580
Local Institution
Pinelands, Western Cape, 7405
Local Institution
Port Elizabeth, Eastern Cape, 6001
Local Institution
Port Elizabeth, Eastern Cape, 6045
Local Institution
Somerset West, Western Cape, 7130
Local Institution
Umhlanga, KwaZulu-Natal, 4321
Local Institution
Wapadrand - Pretoria, Gauteng, 0049
Local Institution
Worcester, Western Cape, 6850
South Korea16 sites
Local Institution
Anyang-si, Gyeonggi-do, 431-070
Local Institution
Daegu, 705718
Local Institution
Goyang, 410-773
Local Institution
Guri-si, Gyeonggi-do, 471-701
Local Institution
Gwangju, 501-757
Local Institution
Incheon, 400-711
Local Institution
Incheon, 405-760
Local Institution
Jeonbuk, 561-712
Local Institution
Jinju, Gyeongsangam-Do, 660-702
Local Institution
Pusan, 602-739
Local Institution
Seoul, 137-701
Local Institution
Seoul, 138-736
Local Institution
Seoul, 152-703
Local Institution
Suwon, 443-721
Local Institution
Wŏnju, Gangwon-do, 220-701
Local Institution
Yangsan, Gyeongangnam-Do, 626-770
Peru14 sites
Local Institution
Bellavista, Provincia Constitucional del Callao, CALLAO 2
Local Institution
Callao, Provincia Constitucional del Callao, CALLAO 2
Local Institution
Chiclayo, Lambayeque
Local Institution
Cusco, Departamento de Cusco
Local Institution
Ica, Ica
Local Institution
Lima, Lima Province, LIMA 11
Local Institution
Lima, Lima Province, LIMA 13
Local Institution
Lima, Lima Province, LIMA 18
Local Institution
Lima, Lima Province, LIMA 1
Local Institution
Lima, Lima Province, LIMA 27
Local Institution
Lima, Lima Province, LIMA 31
Local Institution
Lima, Lima Province, LIMA 33
Local Institution
Lima, Lima Province, LIMA 39
Local Institution
Lima, Lima Province, LIMA 41
Australia13 sites
Local Institution
Ashford, South Australia, 5035
Local Institution
Broken Hill, New South Wales, 2880
Local Institution
Bruce, Australian Capital Territory, 2617
Local Institution
Cairns, Queensland, 4870
Local Institution
Elizabeth Vale, South Australia, 5112
Local Institution
Fitzroy, Victoria, 3065
Local Institution
Geelong, Victoria, 3220
Local Institution
Herston, Queensland, 4031
Local Institution
Kogarah, New South Wales, 2217
Local Institution
Lismore, New South Wales, 2480
Local Institution
Milton, Queensland, 4064
Local Institution
Richmond, Victoria, 3121
Local Institution
Woodville, South Australia, 5011
Romania13 sites
Local Institution
Arad, 310158
Local Institution
Baia Mare, 430031
Local Institution
Brăila, 810249
Local Institution
Bucharest, 011461
Local Institution
Bucharest, 021659
Local Institution
Bucharest, 042122
Local Institution
Bucharest, 050098
Local Institution
Craiova, 200642
Local Institution
Oradea, 410169
Local Institution
Piteşti, 110884
Local Institution
Sibiu, 550245
Local Institution
Târgu Mureş, 540136
Local Institution
Timișoara, 300736
Sweden13 sites
Local Institution
Eskilstuna, 631 88
Local Institution
Halmstad, 30185
Local Institution
Helsingborg, 251 87
Local Institution
Karlskoga, 691 81
Local Institution
Karlstad, 651 85
Local Institution
Köping, 731 81
Local Institution
Lidköping, 531 85
Local Institution
Mölndal, 43180
Local Institution
Skövde, 541 85
Local Institution
Stockholm, 141 86
Local Institution
Stockholm, 171 76
Local Institution
Uppsala, 751 85
Local Institution
Vaxjo, 351 85
Belgium12 sites
Local Institution
Aalst, 9300
Local Institution
Anderlecht, 1070
Local Institution
Antwerp, Antwerpen, 2060
Local Institution
Bonheiden, 2820
Local Institution
Brasschaat, 2930
Local Institution
Bruges, 8000
Local Institution
Ghent, 9000
Local Institution
Huy, 4500
Local Institution
Ieper, 8900
Local Institution
Mechelen, 2800
Local Institution
Mol, 2400
Local Institution
Yvoir, 5530
Chile12 sites
Local Institution
Concepción, Biobio, 4070038
Local Institution
Osorno, Los Lagos Region, 5311089
Local Institution
Port Montt
Local Institution
Punta Arenas, Magallanes Antartica, 6212296
Local Institution
Santiago, Santiago Metropolitan, 6510031
Local Institution
Santiago, Santiago Metropolitan, 7650018
Local Institution
Santiago, Santiago Metropolitan, 8053095
Local Institution
Santiago, Santiago Metropolitan, 8380000
Local Institution
Santiago, Santiago Metropolitan
Local Institution
Talcahuano, Biobio, 4270918
Local Institution
Temuco, Araucania, 4781176
Local Institution
Viña del Mar, Valparaiso, 2570017
Denmark12 sites
Local Institution
Arhus C, 8000
Local Institution
Copenhagen, 2100
Local Institution
Copenhagen, 2300
Local Institution
Copenhagen, 2400
Local Institution
Esbjerg, 6700
Local Institution
Haderslev, 6100
Local Institution
Hellerup, 2900
Local Institution
Hillerød, 3400
Local Institution
Hvidovre, 2650
Local Institution
Næstved, 4700
Local Institution
Silkeborg, 8600
Local Institution
Slagelse, 4200
Norway12 sites
Local Institution
Bergen, 5021
Local Institution
Bodø, 8092
Local Institution
Drammen, 3004
Local Institution
Hamar, 2318
Local Institution
Kongsvinger, 2212
Local Institution
Kristiansund, 6508
Local Institution
Lillehammer, 2629
Local Institution
Oslo, 0319
Local Institution
Oslo, 0407
Local Institution
Oslo, 0514
Local Institution
Stavanger, 4011
Local Institution
Tynset, 2500
France11 sites
Local Institution
Albi, 81013
Local Institution
Amiens, 80054
Local Institution
Avignon, 84082
Local Institution
Cholet, 49325
Local Institution
Lagny-sur-Marne, 77405
Local Institution
Langres, 52206
Local Institution
Montpellier, 34000
Local Institution
Paris, 76561
Local Institution
Pau Universite Cedex, 64046
Local Institution
Strasbourg, 67091
Local Institution
Toulouse, 31076
Slovakia10 sites
Local Institution
Banská Bystrica, 97405
Local Institution
Bratislava, 833 48
Local Institution
Košice, 040 01
Local Institution
Košice, 040 11
Local Institution
Košice, 04001
Local Institution
Kráľovský Chlmec, 07701
Local Institution
Liptovský Hrádok, 033 80
Local Institution
Lučenec, 984 01
Local Institution
Martin, 03639
Local Institution
Nitra, 949 01
Czechia9 sites
Local Institution
Brno, 625 00
Local Institution
Hradec Králové, 500 05
Local Institution
Liberec, 460 63
Local Institution
Nový Jičín, 741 01
Local Institution
Olomouc, 77520
Local Institution
Ostrava, 728 80
Local Institution
Prague, 100 34
Local Institution
Rakovník, 269 29
Local Institution
Ústí nad Orlicí, 562 18
Austria8 sites
Local Institution
Feldkirch, 6800
Local Institution
Graz, 8036
Local Institution
Linz, 4020
Local Institution
Oberpullendorf, 7350
Local Institution
Vienna, 1030
Local Institution
Vienna, 1090
Local Institution
Vienna, 1160
Local Institution
Vienna, 1220
Colombia8 sites
Local Institution
Barranquilla
Local Institution
Bogotá, Cundinamaral
Local Institution
Bogotá
Local Institution
Cali, Valle del Cauca Department
Local Institution
Cartagena, Departamento de Bolívar
Local Institution
Floridablanca
Local Institution
Manizales
Local Institution
Medellín
Turkey (Türkiye)8 sites
Local Institution
Ankara, 06100
Local Institution
Beşevler, Ankara, 06500
Local Institution
Bornova, İzmir, 35100
Local Institution
Diyarbakır, 21280
Local Institution
Isanbul, Haseki
Local Institution
Isparta, 32100
Local Institution
Kirikkale
Local Institution
Konya, 42080
New Zealand6 sites
Local Institution
Auckland, 1030
Local Institution
Auckland, 1640
Local Institution
Christchurch, 8011
Local Institution
Hastings, 4120
Local Institution
Nelson, 7010
Local Institution
Palmerston North, 4410
Switzerland5 sites
Local Institution
Geneva, 1211
Local Institution
Lugano, Canton Ticino, 6900
Local Institution
Sankt Gallen, 9007
Local Institution
Zurich, 8063
Local Institution
Zurich, 8091
Finland4 sites
Local Institution
Espoo, 02740
Local Institution
Helsinki, 00029
Local Institution
Rovaniemi, 96101
Local Institution
Tampere, 33520
Puerto Rico2 sites
Local Institution
Cidra, 00739
Local Institution
San Juan, 00917
Singapore2 sites
Local Institution
Singapore, 168752
Local Institution
Singapore, 768828
About this study
Official title: Apixaban for Prevention of Acute Ischemic Events - 2 A Phase 3, Randomized, Double-Blind, Evaluation of the Safety and Efficacy of Apixaban In Subjects With a Recent Acute Coronary Syndrome
The purpose of this study is to determine if apixaban is superior to placebo for preventing cardiovascular death, non-fatal myocardial infarction, or ischemic stroke in subjects with a recent acute coronary syndrome
- Conditions
- Acute Coronary Syndrome
- Being tested
- Apixaban, Placebo
- Keywords
- NOS
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApixabanDrug
Also called BSM-562247
Tablets, Oral, 5 mg, twice daily, until study end
PlaceboDrug
Tablets, Oral, 0 mg, twice daily, until study end
| Study group | Role | What they receive |
|---|---|---|
| Apixaban | Active comparator | Not described Receives: Drug: Apixaban |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event Rate of Cardiovascular Death, Myocardial Infarction, or Ischemic Stroke During the Intended Treatment Period - Randomized Participants
Event rate was percent of participants with an event of cardiovascular (CV) death, myocardial infarction (MI), or ischemic stroke (number of participants with event/number randomized) per 100 patient (100-pt) years. Study was terminated early and last patient, last visit was in Year 2. Only events confirmed by the adjudication committee were included in the analyses. CV death included deaths due to CV causes (eg, cardiogenic shock, heart failure, arrhythmia/sudden death, cardiac rupture, ischemic stroke, pulmonary embolism, venous/arterial thrombotic events) and other sudden deaths for which an alternative cause was not identified. Intended Treatment Period: the period that started on the day of randomization and ended at the efficacy cut-off date (cut-off date: the date all sites were informed that study drug should be discontinued for all participants, 18 November 2010).
Measured: Randomization (Day 1) to first event (CV death, MI, ischemic stroke), up to March 2011, approximately 2 years
Event Rate of Confirmed Major Bleeding Using Thrombolysis in Myocardial Infarction (TIMI) Criteria During the Treatment Period - Treated Participants
TIMI Major Bleed Criteria: Fatal bleeding, intracranial hemorrhage, and clinically overt bleeding with a hemoglobin (Hgb) drop of ≥ 5 grams per deciliter (g/dL), or ≥15% absolute decrease in hematocrit. To account for transfusions, Hgb measurements were adjusted for transfusions. A transfusion of 1 unit of blood was assumed to result in an increase by 1 g/dL in Hgb or 3% in hematocrit. Event rate was percent of participants with an event of Major Bleed as per TIMI (number of participants with event/number randomized) per 100 patient (100-pt) years. Only events confirmed by the adjudication committee were included in the analyses. Treatment Period=events with onset from first dose to last dose plus 2 days.
Measured: From first dose to first occurrence of event (TIMI major bleeding) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years
Secondary outcomes (10)
Event Rate of Unstable Angina (UA) During the Intended Treatment Period - Randomized Participants
Unstable Angina (UA) defined as worsening or recurrent severe or repetitive angina symptoms at rest lasting at least 10 minutes with at least 2 of the following: New and dynamic electrocardiogram (ECG) changes; angina symptoms leading to inpatient hospitalization; angina symptoms leading to an unplanned or urgent cardiac catheterization, with or without revascularization, that showed evidence of hemodynamically and clinically significant stenosis. Event rate was percent of participants with an event of unstable angina (number of participants with event/number randomized) per 100 patient (100-pt) years. Only events confirmed by the adjudication committee were included in the analyses. Intended Treatment Period: the period that started on the day of randomization and ended at the efficacy cut-off date (cut-off date: the date all sites were informed that study drug should be discontinued for all participants, 18 November 2010).
Measured: Randomization (Day 1) to first event of UA, up to March 2011, approximately 2 years
Event Rate of Stroke During the Intended Treatment Period - Randomized Participants
Event rate was percent of participants with an event of stroke (number of participants with event/number randomized) per 100 patient (100-pt) years. Only events confirmed by the adjudication committee were included in the analyses. Diagnosis of stroke required a new, non-traumatic, focal neurological deficit of sudden onset, lasting at least 24 hours that was not due to a readily identifiable non-vascular cause (ie, brain tumor). All strokes were classified as hemorrhagic (documentation on imaging (eg computed tomography scan or magnetic resonance imaging) of hemorrhage in the cerebral parenchyma, or a subdural or subarachnoid hemorrhage), non-hemorrhagic/ischemic stroke, ischemic stroke with hemorrhagic conversion, or type unknown. Intended Treatment Period: the period that started on the day of randomization (Day 1) and ended at the efficacy cut-off date (notification of study termination).
Measured: Randomization (Day 1) to first event (stroke), up to March 2011, approximately 2 years
Event Rate of Myocardial Infarction (MI) During the Intended Treatment Period - Randomized Participants
MI took into account whether the participant had a recent percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery. Selected key criteria: Elevation of cardiac biomarkers (eg, Creatine Kinase MB fraction (CKMB), Troponin T, Troponin I) above the upper reference limit (URL) plus ischemic symptoms, ECG changes, or imaging evidence of new loss of viable myocardium or new regional wall motion abnormality; Death of CV etiology with new ST-segment elevation or left bundle branch block (LBBB) or fresh intracoronary thrombus by angiography or at autopsy occurring before biomarkers could be obtained or before their appearance in the blood; Following a PCI, elevation of cardiac biomarkers more than 3*URL; Following CABG surgery, elevation of cardiac biomarkers more than 5*URL; New, significant (≥0.04 s) Q waves in ≥2 contiguous leads; Pathologic findings of acute MI. Intended Treatment Period: Day of randomization (Day 1) to efficacy cut-off notice.
Measured: Randomization (Day 1) to first event (MI), up to March 2011, approximately 2 years
Event Rate of Stent Thrombosis During the Intended Treatment Period - Randomized Participants
Stent thrombosis: Definite stent thrombosis considered to have occurred by either angiographic or pathological confirmation; Probable stent thrombosis considered to have occurred in the following cases: any unexplained death within the first 30 days after stent implantation; irrespective of the time after the procedure, any MI that was related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause; Possible stent thrombosis considered to have occurred with any unexplained death from 30 days after intracoronary stenting until end of study (in Year 2). Event rate was percent of participants with an event of stent thrombosis (number with event/number randomized) per 100-pt years. Only events confirmed by the adjudication committee were included in the analyses. Intended Treatment Period: Day of randomization (Day 1) to efficacy cut-off notice of study termination.
Measured: Randomization (Day 1) to first event (stent thrombosis), up to March 2011, approximately 2 years
Event Rate of Composite of Cardiovascular Death, Myocardial Infarction, Unstable Angina, or Ischemic Stroke During the Intended Treatment Period - Randomized Participants
Event rate was percent of participants with an event of CV death, MI, unstable angina (UA), or ischemic stroke (number of participants with event/number randomized) per 100-pt years. Only events confirmed by the adjudication committee were included in the analyses. Each type of event was counted once per participant, but participants could have been counted in multiple categories. Intended Treatment Period: Day of randomization (Day 1) to efficacy cut-off date (notification of study termination).
Measured: Randomization (Day 1) to first event (CV death, MI, UA, Ischemic Stroke, up to March 2011, approximately 2 years
Event Rate of Composite of Cardiovascular Death, Fatal Bleed, Myocardial Infarction, or Stroke During the Intended Treatment Period - Randomized Participants
Event rate was percent of participants with an event of CV death, fatal bleed, MI, or stroke (number of participants with event/number randomized) per 100 patient (100-pt) years. Only events confirmed by the adjudication committee were included in the analyses. CV death included deaths due to CV causes; Diagnosis of stroke required a new, non-traumatic, focal neurological deficit of sudden onset, lasting at least 24 hours that was not due to a readily identifiable non-vascular cause; Fatal bleeding defined as bleeding that Adjudication Committee determined was the primary cause of death or contributed directly to death; MI took into account whether the participant had a recent PCI or CABG surgery. Intended Treatment Period: Day of randomization (Day 1) to efficacy cut-off date (notification of study termination).
Measured: Randomization (Day 1) to first event (CV death, Fatal Bleed, MI, or stroke), up to March 2011, approximately 2 years
Event Rate of Composite of All-Cause Death, Myocardial Infarction, or Stroke During the Intended Treatment Period - Randomized Participants
Cause of death was determined by the principal condition that caused the death, not the immediate mode of death.
CV death: included deaths due to CV causes. Non-CV death: included non-CV deaths caused primarily by a malignancy, infection, bleeding, trauma, non-CV system organ failure, or non-CV surgery. Unknown: included deaths that were not attributable to one of the above categories of CV death or to a non-CV cause. MI accounted whether the participant had a recent PCI or CABG surgery. Diagnosis of stroke required a new, non-traumatic, focal neurological deficit of sudden onset, lasting at least 24 hours that was not due to a readily identifiable non-vascular cause. Only events confirmed by the adjudication committee were included in analyses. Intended Treatment Period: Day of randomization (Day 1) to efficacy cut-off date (notification of study termination).
Measured: Randomization (Day 1) to first event (All Cause Death, MI, or Stroke), up to March 2011, approximately 2 years
Event Rate of Confirmed Major Bleeding Using International Society on Thrombosis and Hemostasis (ISTH) Criteria During the Treatment Period - Treated Participants
ISTH Criteria: Acute clinically overt bleeding defined as new onset, visible bleeding or signs or symptoms suggestive of bleeding confirmed by imaging techniques, which can detect the presence of blood (eg, ultrasound, CT, MRI). Major bleeding: acute clinically overt bleeding accompanied by one or more of the following: A decrease in Hgb of 2 g/dL or more over 24 hours; A transfusion of 2 or more units of packed red blood cells (RBCs); Bleeding that occurs in at least one of the following sites: intracranial, intraspinal, intraocular (within the corpus of the eye; thus, a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal; Bleeding that was fatal. Bleeding events were adjudicated by the Adjudication Committee. Event rate was percent of participants with an event (number with event/number randomized) per 100-pt years. Treatment Period=events with onset from first dose to last dose plus 2 days.
Measured: From first dose to first occurrence of event (ISTH major bleed) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years
Event Rate of Confirmed Major Bleeding or Clinically Relevant Non-Major Bleeding (CRNM) Using ISTH Criteria During the Treatment Period - Treated Participants
ISTH Major bleed: acute clinically overt bleeding accompanied by one or more of the following: A decrease in Hgb of 2 g/dL or more over 24 hours; A transfusion of 2 or more units of packed RBCs; Bleeding that occurs in at least one of the following critical sites: intracranial, intraspinal, intraocular (within the corpus of the eye), pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal; Bleeding that was fatal. CRNM: acute clinically overt bleeding that did not satisfy additional criteria required for the bleeding event to be defined as a major bleeding event and meets at least one of the following: Hospital admission for bleeding; Physician guided medical or surgical treatment for bleeding; Change in anti-thrombotic treatment (anticoagulant or antiplatelet) therapy. Bleeding events were adjudicated by the Adjudication Committee. Treatment Period=events with onset from first dose to last dose plus 2 days.
Measured: From first dose to first occurrence of event (ISTH major or CRNM bleed) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years
Event Rate of All Bleeding Reported by the Investigator During the Treatment Period - Treated Participants
Bleeding events were adjudicated by the Adjudication Committee and classified according to Thrombolysis in Myocardial Infarction (TIMI) major, minor, minimal, and International Society on Thrombosis and Hemostasis (ISTH) major and clinically relevant non-major bleeding (CRNM) criteria. The adjudicated results based on TIMI and ISTH classifications, and programmatically identified events (not adjudicated) according to Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) classification were used in the analyses of bleeding endpoints. GUSTO Bleed Criteria included Severe or life-threatening: Intracranial hemorrhage, or bleeding that causes hemodynamic compromise requiring intervention; Moderate: Bleeding that requires a blood transfusion, but does not result in hemodynamic compromise; Mild: Bleeding that does not meet criteria for either severe or moderate bleeding. Treatment Period=events with onset from first dose to last dose plus 2 days.
Measured: From first dose to first occurrence of event (Bleeding) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 7,484 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer, Duke Clinical Research Institute
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00831441
- Sponsor's protocol ID
- CV185-068
- Other IDs
- EUDRACT# 2008-008298-77
- Acronym
- APPRAISE-2
- Status last verified
- Dec 2015
- First submitted
- 28 Jan 2009
- Last updated
- 27 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Sharma A, Hagstrom E, Wojdyla DM, Neely ML, Harrington RA, Wallentin L, Alexander JH, Goodman SG, Lopes RD; Apixaban for Prevention of Acute Ischemic Safety Events APPRAISE-2 Steering Committee and Investigators. Clinical consequences of bleeding among individuals with a recent acute coronary syndrome: Insights from the APPRAISE-2 trial. Am Heart J. 2019 Sep;215:106-113. doi: 10.1016/j.ahj.2019.05.004. Epub 2019 May 11.
PubMed 31310855Inohara T, Pieper K, Wojdyla DM, Patel MR, Jones WS, Tricoci P, Mahaffey KW, James SK, Alexander JH, Lopes RD, Wallentin L, Ohman EM, Roe MT, Vemulapalli S. Incidence, timing, and type of first and recurrent ischemic events in patients with and without peripheral artery disease after an acute coronary syndrome. Am Heart J. 2018 Jul;201:25-32. doi: 10.1016/j.ahj.2018.03.013. Epub 2018 Mar 28.
PubMed 29910052Sherwood MW, Lopes RD, Sun JL, Liaw D, Harrington RA, Wallentin L, Laskowitz DT, James SK, Goodman SG, Darius H, Lewis BS, Gibson CM, Pieper KS, Alexander JH. Apixaban following acute coronary syndromes in patients with prior stroke: Insights from the APPRAISE-2 trial. Am Heart J. 2018 Mar;197:1-8. doi: 10.1016/j.ahj.2017.09.020. Epub 2017 Oct 24.
PubMed 29447769Guimaraes PO, Lopes RD, Stevens SR, Zimerman A, Wruck L, James SK, Haque G, Giraldez RRCV, Alexander JH, Alexander KP. Reporting Clinical End Points and Safety Events in an Acute Coronary Syndrome Trial: Results With Integrated Collection. J Am Heart Assoc. 2017 Apr 24;6(4):e005490. doi: 10.1161/JAHA.117.005490.
PubMed 28438739Hess CN, James S, Lopes RD, Wojdyla DM, Neely ML, Liaw D, Hagstrom E, Bhatt DL, Husted S, Goodman SG, Lewis BS, Verheugt FWA, De Caterina R, Ogawa H, Wallentin L, Alexander JH. Apixaban Plus Mono Versus Dual Antiplatelet Therapy in Acute Coronary Syndromes: Insights From the APPRAISE-2 Trial. J Am Coll Cardiol. 2015 Aug 18;66(7):777-787. doi: 10.1016/j.jacc.2015.06.027.
PubMed 26271059Khan R, Lopes RD, Neely ML, Stevens SR, Harrington RA, Diaz R, Cools F, Jansky P, Montalescot G, Atar D, Lopez-Sendon J, Flather M, Liaw D, Wallentin L, Alexander JH, Goodman SG; Apixaban for Prevention of Acute Ischemic Safety Events (APPRAISE)-2 Steering Committee and Investigators. Characterising and predicting bleeding in high-risk patients with an acute coronary syndrome. Heart. 2015 Sep;101(18):1475-84. doi: 10.1136/heartjnl-2014-307346. Epub 2015 Jun 24.
PubMed 26109589Mahaffey KW, Hager R, Wojdyla D, White HD, Armstrong PW, Alexander JH, Tricoci P, Lopes RD, Ohman EM, Roe MT, Harrington RA, Wallentin L. Meta-analysis of intracranial hemorrhage in acute coronary syndromes: incidence, predictors, and clinical outcomes. J Am Heart Assoc. 2015 Jun 18;4(6):e001512. doi: 10.1161/JAHA.114.001512.
PubMed 26089177Alexander JH, Lopes RD, James S, Kilaru R, He Y, Mohan P, Bhatt DL, Goodman S, Verheugt FW, Flather M, Huber K, Liaw D, Husted SE, Lopez-Sendon J, De Caterina R, Jansky P, Darius H, Vinereanu D, Cornel JH, Cools F, Atar D, Leiva-Pons JL, Keltai M, Ogawa H, Pais P, Parkhomenko A, Ruzyllo W, Diaz R, White H, Ruda M, Geraldes M, Lawrence J, Harrington RA, Wallentin L; APPRAISE-2 Investigators. Apixaban with antiplatelet therapy after acute coronary syndrome. N Engl J Med. 2011 Aug 25;365(8):699-708. doi: 10.1056/NEJMoa1105819. Epub 2011 Jul 24.
PubMed 21780946
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apixaban for Prevention of Acute Ischemic Events - 2 A Phase 3, Randomized, Double-Blind, Evaluation of the Safety and Efficacy of Apixaban In Subjects With a Recent Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT00831441
- Acronym / sponsor ID
- APPRAISE-2 / CV185-068
- Conditions
- Acute Coronary Syndrome
- Keywords
- NOS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 7,484 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer, Duke Clinical Research Institute
- Study start
- Mar 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 29 Jan 2009 (estimated)
- Results
- Posted 27 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if apixaban is superior to placebo for preventing cardiovascular death, non-fatal myocardial infarction, or ischemic stroke in subjects with a recent acute coronary syndrome
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apixaban | Active comparator | Drug: Apixaban |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acute coronary syndrome (ACS)
- Clinically stable
- Receiving standard of care for ACS
Key exclusion criteria (3 listed)
- Severe hypertension
- Active bleeding or high risk for major bleeding
- Hemoglobin < 9 g/dL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApixabanAlso: BSM-562247Tablets, Oral, 5 mg, twice daily, until study end | Drug | Apixaban |
| PlaceboTablets, Oral, 0 mg, twice daily, until study end | Drug | Placebo |
Primary outcome
Event Rate of Cardiovascular Death, Myocardial Infarction, or Ischemic Stroke During the Intended Treatment Period - Randomized Participants
Time frame: Randomization (Day 1) to first event (CV death, MI, ischemic stroke), up to March 2011, approximately 2 years
Event rate was percent of participants with an event of cardiovascular (CV) death, myocardial infarction (MI), or ischemic stroke (number of participants with event/number randomized) per 100 patient (100-pt) years. Study was terminated early and last patient, last visit was in Year 2. Only events confirmed by the adjudication committee were included in the analyses. CV death included deaths due to CV causes (eg, cardiogenic shock, heart failure, arrhythmia/sudden death, cardiac rupture, ischemic stroke, pulmonary embolism, venous/arterial thrombotic events) and other sudden deaths for which an alternative cause was not identified. Intended Treatment Period: the period that started on the day of randomization and ended at the efficacy cut-off date (cut-off date: the date all sites were informed that study drug should be discontinued for all participants, 18 November 2010).
Event Rate of Confirmed Major Bleeding Using Thrombolysis in Myocardial Infarction (TIMI) Criteria During the Treatment Period - Treated Participants
Time frame: From first dose to first occurrence of event (TIMI major bleeding) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years
TIMI Major Bleed Criteria: Fatal bleeding, intracranial hemorrhage, and clinically overt bleeding with a hemoglobin (Hgb) drop of ≥ 5 grams per deciliter (g/dL), or ≥15% absolute decrease in hematocrit. To account for transfusions, Hgb measurements were adjusted for transfusions. A transfusion of 1 unit of blood was assumed to result in an increase by 1 g/dL in Hgb or 3% in hematocrit. Event rate was percent of participants with an event of Major Bleed as per TIMI (number of participants with event/number randomized) per 100 patient (100-pt) years. Only events confirmed by the adjudication committee were included in the analyses. Treatment Period=events with onset from first dose to last dose plus 2 days.
10 secondary outcomes
Event Rate of Unstable Angina (UA) During the Intended Treatment Period - Randomized Participants
Time frame: Randomization (Day 1) to first event of UA, up to March 2011, approximately 2 years
Event Rate of Stroke During the Intended Treatment Period - Randomized Participants
Time frame: Randomization (Day 1) to first event (stroke), up to March 2011, approximately 2 years
Event Rate of Myocardial Infarction (MI) During the Intended Treatment Period - Randomized Participants
Time frame: Randomization (Day 1) to first event (MI), up to March 2011, approximately 2 years
Event Rate of Stent Thrombosis During the Intended Treatment Period - Randomized Participants
Time frame: Randomization (Day 1) to first event (stent thrombosis), up to March 2011, approximately 2 years
Event Rate of Composite of Cardiovascular Death, Myocardial Infarction, Unstable Angina, or Ischemic Stroke During the Intended Treatment Period - Randomized Participants
Time frame: Randomization (Day 1) to first event (CV death, MI, UA, Ischemic Stroke, up to March 2011, approximately 2 years
Event Rate of Composite of Cardiovascular Death, Fatal Bleed, Myocardial Infarction, or Stroke During the Intended Treatment Period - Randomized Participants
Time frame: Randomization (Day 1) to first event (CV death, Fatal Bleed, MI, or stroke), up to March 2011, approximately 2 years
Event Rate of Composite of All-Cause Death, Myocardial Infarction, or Stroke During the Intended Treatment Period - Randomized Participants
Time frame: Randomization (Day 1) to first event (All Cause Death, MI, or Stroke), up to March 2011, approximately 2 years
Event Rate of Confirmed Major Bleeding Using International Society on Thrombosis and Hemostasis (ISTH) Criteria During the Treatment Period - Treated Participants
Time frame: From first dose to first occurrence of event (ISTH major bleed) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years
Event Rate of Confirmed Major Bleeding or Clinically Relevant Non-Major Bleeding (CRNM) Using ISTH Criteria During the Treatment Period - Treated Participants
Time frame: From first dose to first occurrence of event (ISTH major or CRNM bleed) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years
Event Rate of All Bleeding Reported by the Investigator During the Treatment Period - Treated Participants
Time frame: From first dose to first occurrence of event (Bleeding) during Treatment Period (first dose to last dose + 2 days), up to March 2011, approximately 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31310855Sharma A, Hagstrom E, Wojdyla DM, Neely ML, Harrington RA, Wallentin L, Alexander JH, Goodman SG, Lopes RD; Apixaban for Prevention of Acute Ischemic Safety Events APPRAISE-2 Steering Committee and Investigators. Clinical consequences of bleeding among individuals with a recent acute coronary syndrome: Insights from the APPRAISE-2 trial. Am Heart J. 2019 Sep;215:106-113. doi: 10.1016/j.ahj.2019.05.004. Epub 2019 May 11.
- Derived from this study: PubMed 29910052Inohara T, Pieper K, Wojdyla DM, Patel MR, Jones WS, Tricoci P, Mahaffey KW, James SK, Alexander JH, Lopes RD, Wallentin L, Ohman EM, Roe MT, Vemulapalli S. Incidence, timing, and type of first and recurrent ischemic events in patients with and without peripheral artery disease after an acute coronary syndrome. Am Heart J. 2018 Jul;201:25-32. doi: 10.1016/j.ahj.2018.03.013. Epub 2018 Mar 28.
- Derived from this study: PubMed 29447769Sherwood MW, Lopes RD, Sun JL, Liaw D, Harrington RA, Wallentin L, Laskowitz DT, James SK, Goodman SG, Darius H, Lewis BS, Gibson CM, Pieper KS, Alexander JH. Apixaban following acute coronary syndromes in patients with prior stroke: Insights from the APPRAISE-2 trial. Am Heart J. 2018 Mar;197:1-8. doi: 10.1016/j.ahj.2017.09.020. Epub 2017 Oct 24.
- Derived from this study: PubMed 28438739Guimaraes PO, Lopes RD, Stevens SR, Zimerman A, Wruck L, James SK, Haque G, Giraldez RRCV, Alexander JH, Alexander KP. Reporting Clinical End Points and Safety Events in an Acute Coronary Syndrome Trial: Results With Integrated Collection. J Am Heart Assoc. 2017 Apr 24;6(4):e005490. doi: 10.1161/JAHA.117.005490.
- Derived from this study: PubMed 26271059Hess CN, James S, Lopes RD, Wojdyla DM, Neely ML, Liaw D, Hagstrom E, Bhatt DL, Husted S, Goodman SG, Lewis BS, Verheugt FWA, De Caterina R, Ogawa H, Wallentin L, Alexander JH. Apixaban Plus Mono Versus Dual Antiplatelet Therapy in Acute Coronary Syndromes: Insights From the APPRAISE-2 Trial. J Am Coll Cardiol. 2015 Aug 18;66(7):777-787. doi: 10.1016/j.jacc.2015.06.027.
- Derived from this study: PubMed 26109589Khan R, Lopes RD, Neely ML, Stevens SR, Harrington RA, Diaz R, Cools F, Jansky P, Montalescot G, Atar D, Lopez-Sendon J, Flather M, Liaw D, Wallentin L, Alexander JH, Goodman SG; Apixaban for Prevention of Acute Ischemic Safety Events (APPRAISE)-2 Steering Committee and Investigators. Characterising and predicting bleeding in high-risk patients with an acute coronary syndrome. Heart. 2015 Sep;101(18):1475-84. doi: 10.1136/heartjnl-2014-307346. Epub 2015 Jun 24.
- Derived from this study: PubMed 26089177Mahaffey KW, Hager R, Wojdyla D, White HD, Armstrong PW, Alexander JH, Tricoci P, Lopes RD, Ohman EM, Roe MT, Harrington RA, Wallentin L. Meta-analysis of intracranial hemorrhage in acute coronary syndromes: incidence, predictors, and clinical outcomes. J Am Heart Assoc. 2015 Jun 18;4(6):e001512. doi: 10.1161/JAHA.114.001512.
- Derived from this study: PubMed 21780946Alexander JH, Lopes RD, James S, Kilaru R, He Y, Mohan P, Bhatt DL, Goodman S, Verheugt FW, Flather M, Huber K, Liaw D, Husted SE, Lopez-Sendon J, De Caterina R, Jansky P, Darius H, Vinereanu D, Cornel JH, Cools F, Atar D, Leiva-Pons JL, Keltai M, Ogawa H, Pais P, Parkhomenko A, Ruzyllo W, Diaz R, White H, Ruda M, Geraldes M, Lawrence J, Harrington RA, Wallentin L; APPRAISE-2 Investigators. Apixaban with antiplatelet therapy after acute coronary syndrome. N Engl J Med. 2011 Aug 25;365(8):699-708. doi: 10.1056/NEJMoa1105819. Epub 2011 Jul 24.
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Giant Cell Arteritis (GCA), Acute Coronary Syndrome (ACS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1,012 sites in 40 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Apixaban in people with Acute Coronary Syndrome, run by Bristol-Myers Squibb at 1,012 sites in 40 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1,012 sites in United States, Russia, Brazil, Japan, Argentina and 35 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event Rate of Cardiovascular Death, Myocardial Infarction, or Ischemic Stroke During the Intended Treatment Period - Randomized Participants (time frame: Randomization (Day 1) to first event (CV death, MI, ischemic stroke), up to March 2011, approximately 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00831441, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2016.