AtherosclerosisPhase 3CANTOSNCT01327846
Cardiovascular Risk Reduction Study (Reduction in Recurrent Major CV Disease Events)
A Phase 3 study testing Canakinumab in people with Atherosclerosis, run by Novartis Pharmaceuticals at 1,131 sites in 40 countries.
Trial summary
Main Study (CACZ885M2301): The purpose of the pivotal phase of this trial was to test the hypothesis that canakinumab treatment of patients with myocardial infarction (MI) at least one month prior to study entry and elevated hsCRP could prevent recurrent cardiovascular events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- Canakinumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10,066 participants
- Where
- 1,131 sitesin 40 countries
- Study dates
- 11 Apr 2011to 14 Apr 2019
- 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
Main Study Inclusion Criteria:
- Written informed consent
- Male, or Female of non-child-bearing potential
- Age ≥ 18 years.
- Spontaneous MI at least 30 days before randomization. hsCRP ≥ 2 mg/L
Substudy 1 Inclusion:
- All Inclusion from Main Study
- Acquisition of evaluable baseline MRI images of bilateral carotid arteries by the imaging core laboratory
Substudy 2 Inclusion:
- All inclusion from Main Study
- T2D at baseline per Main protocol criteria and be on a stable anti-hyperglycemic medication for at least 4 weeks prior to the baseline OGTT test
- Willing to have the OGTT assessment started before 10 am
Main Study Exclusion Criteria:
- Pregnant or nursing (lactating) women
- Women of child-bearing potential
- Any of the following concomitant diseases
- Planned coronary revascularization (PCI or CABG)
- Major non-cardiac surgical or endoscopic procedure within past 6 months
- Multi-vessel CABG surgery within the past 3 years
- Symptomatic patients with Class IV heart failure (HF) (New York Heart Association [NYHA].
- Uncontrolled hypertension
- Uncontrolled diabetes
- History or evidence of active tuberculosis (TB) infection Substudy 1 Exclusion
- All Main exclusion
- Patients with prior history of carotid angioplasty, stenting, or carotid atherectomy
- Patients with contraindications to MRI examination (brain aneurysm clip, implanted neural stimulator, implanted cardiac pacemaker, pacemaker wires or defibrillator, prosthetic heart valves, cochlear implant, ocular foreign body or other implanted body, tattoos, implanted insulin pump, metal shrapnel or bullet)
- Patients prone to claustrophobia or known anxiety disorders
- BMI > 40 kg/m2 Substudy 2 Exclusion
- This sub-study does not have any additional exclusion criteria.
Trial locations and contacts
1,131 sites in 40 countries.
1116 sites in 40 countries
United States300 sites
Novartis Investigative Site
Abington, Pennsylvania, 19001
Novartis Investigative Site
Akron, Ohio, 44309
Novartis Investigative Site
Albuquerque, New Mexico, 87102
Novartis Investigative Site
Allen, Texas, 75002-3688
Novartis Investigative Site
Altoona, Pennsylvania, 16602
Novartis Investigative Site
Ames, Iowa, 50010
Novartis Investigative Site
Anchorage, Alaska, 99508
Novartis Investigative Site
Anderson, South Carolina, 29621
Novartis Investigative Site
Ann Arbor, Michigan, 48106
Novartis Investigative Site
Asheboro, North Carolina, 27204
Novartis Investigative Site
Athens, Alabama, 35611
Novartis Investigative Site
Athens, Georgia, 30606
Novartis Investigative Site
Augusta, Georgia, 30904
Novartis Investigative Site
Aurora, Colorado, 80012
Novartis Investigative Site
Baltimore, Maryland, 21204
Novartis Investigative Site
Bartlesville, Oklahoma, 74006
Novartis Investigative Site
Baton Rouge, Louisiana, 70808
Novartis Investigative Site
Baton Rouge, Louisiana, 70816
Novartis Investigative Site
Beaumont, Texas, 77701
Novartis Investigative Site
Beaumont, Texas, 77702
Novartis Investigative Site
Beaver, Pennsylvania, 15009
Novartis Investigative Site
Bedford, Texas, 76021
Novartis Investigative Site
Beltsville, Maryland, 20705
Novartis Investigative Site
Bend, Oregon, 97701
Novartis Investigative Site
Beverly Hills, California, 90211
Novartis Investigative Site
Binghamton, New York, 13901
Novartis Investigative Site
Birmingham, Alabama, 35235-3424
Novartis Investigative Site
Birmingham, Alabama, 35243
Novartis Investigative Site
Birmingham, Alabama, 35294-2041
Novartis Investigative Site
Bloomington, Minnesota, 55420
Novartis Investigative Site
Bountiful, Utah, 84010
Novartis Investigative Site
Bridgeville, Pennsylvania, 15017
Novartis Investigative Site
Brownsville, Texas, 78520
Novartis Investigative Site
Burke, Virginia, 22015
Novartis Investigative Site
Burlington, Massachusetts, 01803
Novartis Investigative Site
Camden, New Jersey, 08103
Novartis Investigative Site
Camp Hill, Pennsylvania, 17011
Novartis Investigative Site
Carmichael, California, 95608
Novartis Investigative Site
Chandler, Arizona, 85224
Novartis Investigative Site
Charlotte, North Carolina, 28277
Novartis Investigative Site
Chelsea, Michigan, 48118
Novartis Investigative Site
Chicago, Illinois, 60611
Novartis Investigative Site
Cincinnati, Ohio, 45219
Novartis Investigative Site
Cincinnati, Ohio, 45245
Novartis Investigative Site
Clearwater, Florida, 33756
Novartis Investigative Site
Cleveland, Ohio, 44109-1998
Novartis Investigative Site
Coeur d'Alene, Idaho, 83814
Novartis Investigative Site
Colorado Springs, Colorado, 80907
Novartis Investigative Site
Columbia, Maryland, 21044
Novartis Investigative Site
Columbia, Missouri, 65212
Novartis Investigative Site
Columbia, South Carolina, 29201
Novartis Investigative Site
Columbus, Ohio, 43235
Novartis Investigative Site
Coral Springs, Florida, 33065
Novartis Investigative Site
Covington, Georgia, 30014
Novartis Investigative Site
Covington, Louisiana, 70433
Novartis Investigative Site
Cumberland, Rhode Island, 02864-1410
Novartis Investigative Site
Cumming, Georgia, 30041
Novartis Investigative Site
Dallas, Texas, 75204
Novartis Investigative Site
Dallas, Texas, 75226
Novartis Investigative Site
Dallas, Texas, 75231
Novartis Investigative Site
Danville, Virginia, 24541
Novartis Investigative Site
Davie, Florida, 33324
Novartis Investigative Site
Dayton, Ohio, 45402
Novartis Investigative Site
Daytona Beach, Florida, 32114
Novartis Investigative Site
Decatur, Georgia, 30033
Novartis Investigative Site
Decatur, Georgia, 30035
Novartis Investigative Site
DeFuniak Springs, Florida, 32435
Novartis Investigative Site
Denver, Colorado, 80204-4507
Novartis Investigative Site
Denver, Colorado, 80206
Novartis Investigative Site
Denver, Colorado, 80218
Novartis Investigative Site
Denver, Colorado, 80220
Novartis Investigative Site
Detroit, Michigan, 48202
Novartis Investigative Site
Doral, Florida, 33136
Novartis Investigative Site
Duluth, Georgia, 30096
Novartis Investigative Site
Duluth, Minnesota, 55805
Novartis Investigative Site
Edina, Minnesota, 55435
Novartis Investigative Site
Endwell, New York, 13760
Novartis Investigative Site
Erie, Pennsylvania, 16507
Novartis Investigative Site
Escondido, California, 92025
Novartis Investigative Site
Evansville, Indiana, 47712
Novartis Investigative Site
Evansville, Indiana, 47714
Novartis Investigative Site
Fairhope, Alabama, 36532
Novartis Investigative Site
Fall River, Massachusetts, 02720
Novartis Investigative Site
Fargo, North Dakota, 58122
Novartis Investigative Site
Fort Mill, South Carolina, 29707
Novartis Investigative Site
Freehold, New Jersey, 07728
Novartis Investigative Site
Fridley, Minnesota, 55432
Novartis Investigative Site
Fullerton, California, 92835
Novartis Investigative Site
Germantown, Tennessee, 38138
Novartis Investigative Site
Glendale, Arizona, 85306
Novartis Investigative Site
Gonzales, Texas, 78629
Novartis Investigative Site
Grand Blanc, Michigan, 48439
Novartis Investigative Site
Grand Forks, North Dakota, 58201
Novartis Investigative Site
Grand Island, Nebraska, 68803
Novartis Investigative Site
Greensboro, North Carolina, 27401
Novartis Investigative Site
Greensboro, North Carolina, 27410
Novartis Investigative Site
Greenville, North Carolina, 27834
Novartis Investigative Site
Greenville, South Carolina, 29605
Novartis Investigative Site
Greenville, Tennessee, 37745
Novartis Investigative Site
Greenville, Texas, 75401
Novartis Investigative Site
Greer, South Carolina, 29651
Novartis Investigative Site
Hattiesburg, Mississippi, 39401
Novartis Investigative Site
Haverhill, Massachusetts, 01830
Novartis Investigative Site
Hershey, Pennsylvania, 17033
Novartis Investigative Site
Hialeah, Florida, 33012
Novartis Investigative Site
Hickory, North Carolina, 28601
Novartis Investigative Site
Hollywood, Florida, 33021
Novartis Investigative Site
Hollywood, Florida, 33312
Novartis Investigative Site
Honolulu, Hawaii, 96814
Novartis Investigative Site
Hopewell, Virginia, 23860
Novartis Investigative Site
Hot Springs, Arkansas, 71913
Novartis Investigative Site
Houma, Louisiana, 70360
Novartis Investigative Site
Houston, Texas, 77025
Novartis Investigative Site
Houston, Texas, 77030
Novartis Investigative Site
Houston, Texas, 77055
Novartis Investigative Site
Houston, Texas, 77064
Novartis Investigative Site
Houston, Texas, 77070
Novartis Investigative Site
Houston, Texas, 77081
Novartis Investigative Site
Huntington Beach, California, 92647
Novartis Investigative Site
Huntsville, Alabama, 35801
Novartis Investigative Site
Irving, Texas, 75039
Novartis Investigative Site
Jackson, Mississippi, 39209
Novartis Investigative Site
Jackson, Tennessee, 38305
Novartis Investigative Site
Jacksonville, Florida, 32204
Novartis Investigative Site
Jacksonville, Florida, 32209-6511
Novartis Investigative Site
Jacksonville, Florida, 32216
Novartis Investigative Site
Jacksonville, Florida, 32223
Novartis Investigative Site
Jacksonville Beach, Florida, 32050
Novartis Investigative Site
Jerseyville, Illinois, 62052
Novartis Investigative Site
Johnson City, Tennessee, 37604
Novartis Investigative Site
Jonesboro, Arkansas, 72401
Novartis Investigative Site
Jupiter, Florida, 33458
Novartis Investigative Site
Kalamazoo, Michigan, 49008
Novartis Investigative Site
Kansas City, Kansas, 66160
Novartis Investigative Site
Kansas City, Missouri, 64111
Novartis Investigative Site
Kew Gardens, New York, 11415
Novartis Investigative Site
Knoxville, Tennessee, 37917
Novartis Investigative Site
Knoxville, Tennessee, 37920
Novartis Investigative Site
Knoxville, Tennessee, 37934
Novartis Investigative Site
Lafayette, Louisiana, 70501
Novartis Investigative Site
Lafayette, Louisiana, 70508
Novartis Investigative Site
Lake Jackson, Texas, 77566
Novartis Investigative Site
Lancaster, California, 93534
Novartis Investigative Site
Las Vegas, Nevada, 89118
Novartis Investigative Site
Layton, Utah, 84041
Novartis Investigative Site
Leander, Texas, 78641
Novartis Investigative Site
Lexington, Kentucky, 40509
Novartis Investigative Site
Lincoln, Nebraska, 68516
Novartis Investigative Site
Little Rock, Arkansas, 72204
Novartis Investigative Site
Livingston, Texas, 77351
Novartis Investigative Site
Lodi, New Jersey, 07644
Novartis Investigative Site
Loma Linda, California, 92354
Novartis Investigative Site
Loma Linda, California, 92357
Novartis Investigative Site
Lombard, Illinois, 60148
Novartis Investigative Site
Long Beach, California, 90806
Novartis Investigative Site
Los Angeles, California, 90033
Novartis Investigative Site
Los Angeles, California, 90073
Novartis Investigative Site
Los Gatos, California, 95032
Novartis Investigative Site
Louisville, Kentucky, 40206
Novartis Investigative Site
Lufkin, Texas, 75904
Novartis Investigative Site
Macon, Georgia, 31201
Novartis Investigative Site
Madison, Wisconsin, 53713
Novartis Investigative Site
Madisonville, Kentucky, 42431
Novartis Investigative Site
Mandeville, Louisiana, 70471
Novartis Investigative Site
Marion, Ohio, 43302
Novartis Investigative Site
Marshall, Texas, 75670
Novartis Investigative Site
McAllen, Texas, 78501
Novartis Investigative Site
McKinney, Texas, 75069
Novartis Investigative Site
Melrose Park, Illinois, 60160
Novartis Investigative Site
Memphis, Tennessee, 38120
Novartis Investigative Site
Metairie, Louisiana, 70001
Novartis Investigative Site
Metairie, Louisiana, 70006
Novartis Investigative Site
Miami, Florida, 33126
Novartis Investigative Site
Miami, Florida, 33135
Novartis Investigative Site
Miami, Florida, 33155
Novartis Investigative Site
Miami, Florida, 33176
Novartis Investigative Site
Miami Beach, Florida, 33140
Novartis Investigative Site
Midland, Michigan, 48640
Novartis Investigative Site
Minden, Louisiana, 71055
Novartis Investigative Site
Mineola, New York, 11501
Novartis Investigative Site
Minneapolis, Minnesota, 55433
Novartis Investigative Site
Mission Viejo, California, 92691
Novartis Investigative Site
Mobile, Alabama, 36604
Novartis Investigative Site
Mobile, Alabama, 36608
Novartis Investigative Site
Mobile, Alabama, 36617-2293
Novartis Investigative Site
Moncks Corner, South Carolina, 29461
Novartis Investigative Site
Mooresville, North Carolina, 28117
Novartis Investigative Site
Mt. Pleasant, South Carolina, 29464
Novartis Investigative Site
Naples, Florida, 34119
Novartis Investigative Site
Nashua, New Hampshire, 03060
Novartis Investigative Site
New Brunswick, New Jersey, 08901
Novartis Investigative Site
New Orleans, Louisiana, 70115
Novartis Investigative Site
New Orleans, Louisiana, 70119
Novartis Investigative Site
New York, New York, 10003
Novartis Investigative Site
New York, New York, 10016
Novartis Investigative Site
New York, New York, 10035
Novartis Investigative Site
Newark, Delaware, 19713
Novartis Investigative Site
Newport Beach, California, 92663
Novartis Investigative Site
North Myrtle Beach, South Carolina, 29582
Novartis Investigative Site
Northridge, California, 91325
Novartis Investigative Site
Norwich, Connecticut, 06360
Novartis Investigative Site
Novi, Michigan, 48374
Novartis Investigative Site
Ocean City, New Jersey, 07712
Novartis Investigative Site
Oceanside, California, 92056
Novartis Investigative Site
Odessa, Texas, 79761
Novartis Investigative Site
Oklahoma City, Oklahoma, 73120
Novartis Investigative Site
Omaha, Nebraska, 68114
Novartis Investigative Site
Omaha, Nebraska, 68131
Novartis Investigative Site
Omaha, Nebraska, 68134
Novartis Investigative Site
Opelousas, Louisiana, 70570
Novartis Investigative Site
Orangeburg, South Carolina, 29115
Novartis Investigative Site
Orangevale, California, 95662
Novartis Investigative Site
Orlando, Florida, 32822
Novartis Investigative Site
Overland Park, Kansas, 66204
Novartis Investigative Site
Owensboro, Kentucky, 42303
Novartis Investigative Site
Palm Springs, California, 92262
Novartis Investigative Site
Pasadena, California, 91105
Novartis Investigative Site
Pembroke Pines, Florida, 33024
Novartis Investigative Site
Peoria, Illinois, 61602
Novartis Investigative Site
Petoskey, Michigan, 49770
Novartis Investigative Site
Phoenix, Arizona, 85018
Novartis Investigative Site
Phoenix, Arizona, 85032
Novartis Investigative Site
Picayune, Mississippi, 39466
Novartis Investigative Site
Pinehurst, North Carolina, 28374
Novartis Investigative Site
Pinellas Park, Florida, 33781
Novartis Investigative Site
Pittsburgh, Pennsylvania, 15216
Novartis Investigative Site
Pittsburgh, Pennsylvania, 15236
Novartis Investigative Site
Pittsburgh, Pennsylvania, 15243
Novartis Investigative Site
Pomona, California, 91767
Novartis Investigative Site
Pomona, New Jersey, 08240
Novartis Investigative Site
Port Charlotte, Florida, 33952
Novartis Investigative Site
Port Orange, Florida, 32127
Novartis Investigative Site
Port Orchard, Washington, 98366
Novartis Investigative Site
Portland, Maine, 04102
Novartis Investigative Site
Portland, Oregon, 97225
Novartis Investigative Site
Pottstown, Pennsylvania, 19464
Novartis Investigative Site
Providence, Rhode Island, 02904
Novartis Investigative Site
Providence, Rhode Island, 02906
Novartis Investigative Site
Rapid City, South Dakota, 57701
Novartis Investigative Site
Renton, Washington, 98057
Novartis Investigative Site
Richmond, Virginia, 23249
Novartis Investigative Site
Richmond, Virginia, 23298
Novartis Investigative Site
Ridgewood, New Jersey, 07450
Novartis Investigative Site
Robbinsdale, Minnesota, 55422
Novartis Investigative Site
Rochester, New York, 14609
Novartis Investigative Site
Rochester, New York, 14621
Novartis Investigative Site
Roswell, Georgia, 30076
Novartis Investigative Site
Royal Oak, Michigan, 48073
Novartis Investigative Site
Sacramento, California, 95816
Novartis Investigative Site
Sacramento, California, 95819
Novartis Investigative Site
Saginaw, Michigan, 48601
Novartis Investigative Site
Saint Cloud, Minnesota, 56303
Novartis Investigative Site
Saint Paul, Minnesota, 55102
Novartis Investigative Site
Salisbury, North Carolina, 28144
Novartis Investigative Site
Salt Lake City, Utah, 84102
Novartis Investigative Site
Salt Lake City, Utah, 84107
Novartis Investigative Site
Salt Lake City, Utah, 84124
Novartis Investigative Site
San Antonio, Texas, 78212
Novartis Investigative Site
San Antonio, Texas, 78229-3900
Novartis Investigative Site
San Antonio, Texas, 78229-4801
Novartis Investigative Site
San Antonio, Texas, 78229
Novartis Investigative Site
San Antonio, Texas, 78234
Novartis Investigative Site
San Antonio, Texas, 78238-7676
Novartis Investigative Site
San Antonio, Texas, 78258
Novartis Investigative Site
San Diego, California, 92101
Novartis Investigative Site
San Diego, California, 92120
Novartis Investigative Site
San Diego, California, 92128
Novartis Investigative Site
San Diego, California, 92161
Novartis Investigative Site
San Francisco, California, 94143-0792
Novartis Investigative Site
Sanford, North Carolina, 27330
Novartis Investigative Site
Santa Ana, California, 92704
Novartis Investigative Site
Santa Rosa, California, 95405
Novartis Investigative Site
Sarasota, Florida, 34239
Novartis Investigative Site
Savannah, Georgia, 31406
Novartis Investigative Site
Seattle, Washington, 98104
Novartis Investigative Site
Seattle, Washington, 98122
Novartis Investigative Site
Shreveport, Louisiana, 71101
Novartis Investigative Site
Shreveport, Louisiana, 71103
Novartis Investigative Site
Sioux Falls, South Dakota, 57104
Novartis Investigative Site
Slidell, Louisiana, 70458
Novartis Investigative Site
South Miami, Florida, 33143
Novartis Investigative Site
Springfield, Missouri, 65807
Novartis Investigative Site
St Louis, Missouri, 63110
Novartis Investigative Site
St Louis, Missouri, 63128
Novartis Investigative Site
St Louis, Missouri, 63141
Novartis Investigative Site
Statesville, North Carolina, 28625
Novartis Investigative Site
Sugar Land, Texas, 77479
Novartis Investigative Site
Tacoma, Washington, 98405
Novartis Investigative Site
Tampa, Florida, 33613
Novartis Investigative Site
Tampa, Florida, 33624
Novartis Investigative Site
Temple, Texas, 76508
Novartis Investigative Site
Thomasville, Georgia, 31792
Novartis Investigative Site
Tomball, Texas, 77375
Novartis Investigative Site
Topeka, Kansas, 66606
Novartis Investigative Site
Torrance, California, 90502
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Tulsa, Oklahoma, 74133
Novartis Investigative Site
Tustin, California, 92780
Novartis Investigative Site
Uniontown, Pennsylvania, 15401
Novartis Investigative Site
Varnville, South Carolina, 29944
Novartis Investigative Site
Visalia, California, 93291
Germany83 sites
Novartis Investigative Site
Bad Krozingen, 79189
Novartis Investigative Site
Balve, 58802
Novartis Investigative Site
Berlin, 10117
Novartis Investigative Site
Berlin, 10367
Novartis Investigative Site
Berlin, 10629
Novartis Investigative Site
Berlin, 10789
Novartis Investigative Site
Berlin, 12627
Novartis Investigative Site
Berlin, 13055
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Bochum, 44787
Novartis Investigative Site
Borna, 04552
Novartis Investigative Site
Chemnitz, 09122
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Chemnitz, 09130
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Cologne, 51065
Novartis Investigative Site
Dillingen, 66763
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Dinslaken, 46535
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Dortmund, 44137
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Dresden, 01067
Novartis Investigative Site
Dresden, 01069
Novartis Investigative Site
Dresden, 01277
Novartis Investigative Site
Dresden, 01307
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Dresden, 01309
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Duisburg, 47137
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Düsseldorf, 40597
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Ebersbach, 02730
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Elsterwerda, 04910
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Erlangen, 91054
Novartis Investigative Site
Essen, 45136
Novartis Investigative Site
Essen, 45276
Novartis Investigative Site
Essen, 45355
Novartis Investigative Site
Falkensee, 14612
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Frankfurt, 60488
Novartis Investigative Site
Frankfurt, 60594
Novartis Investigative Site
Frankfurt am Main, 60313
Novartis Investigative Site
Freiburg im Breisgau, 79106
Novartis Investigative Site
Fulda, 36037
Novartis Investigative Site
Giengen an der Brenz, 89537
Novartis Investigative Site
Görlitz, 02826
Novartis Investigative Site
Haag, 83527
Novartis Investigative Site
Halle, 06120
Novartis Investigative Site
Hamburg, 20246
Novartis Investigative Site
Hamburg, 22041
Novartis Investigative Site
Hamburg, 22177
Novartis Investigative Site
Hamburg, 22393
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Hamburg, 22765
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Heidelberg, 69120
Novartis Investigative Site
Heilbronn, 74078
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Huy / OT Anderbeck, 38836
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Jerichow, 39319
Novartis Investigative Site
Kallstadt, 67169
Novartis Investigative Site
Kamp-Lintfort, 47475
Novartis Investigative Site
Kassel, 34127
Novartis Investigative Site
Kiel, 24119
Novartis Investigative Site
Koblenz, 56068
Novartis Investigative Site
Künzing, 94550
Novartis Investigative Site
Leipzig, 04103
Novartis Investigative Site
Leipzig, 04107
Novartis Investigative Site
Ludwigshafen, 67063
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Lüneburg, 21339
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Magdeburg, 39112
Novartis Investigative Site
Mainz, 55116
Novartis Investigative Site
Mainz, 55131
Novartis Investigative Site
Mayen, 56727
Novartis Investigative Site
Meissen, 01662
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Meißen, 01662
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Muehldorf Am Inn, 84453
Novartis Investigative Site
Muehlheim An Der Ruhr, North Rhine-Westphalia, 45468
Novartis Investigative Site
Mühlhausen, 99974
Novartis Investigative Site
Neuhofen, 67141
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Neunkirchen, 66539
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Northeim, 37154
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Nuremberg, 90402
Novartis Investigative Site
Oelde, 59302
Novartis Investigative Site
Oschatz, 04758
Novartis Investigative Site
Paderborn, 33098
Novartis Investigative Site
Potsdam, 14469
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Rednitzhembach, 91126
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Reinfeld, 23858
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Rostock, 06120
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Rüdersdorf, 15562
Novartis Investigative Site
Siegen, 57072
Novartis Investigative Site
Ulm, 89081
Novartis Investigative Site
Wolmirstedt, 39326
Argentina53 sites
Novartis Investigative Site
Bahía Blanca, Buenos Aires, B8000AAT
Novartis Investigative Site
CABA, Buenos Aires, 1428
Novartis Investigative Site
CABA, Buenos Aires, C1056ABJ
Novartis Investigative Site
CABA, Buenos Aires, C1221ADC
Novartis Investigative Site
CABA, Buenos Aires, C1425AGC
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CABA, Buenos Aires, C1425BWO
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CABA, Buenos Aires, C1440AAD
Novartis Investigative Site
CABA, Buenos Aires F.D., C1179AAB
Novartis Investigative Site
CABA, Buenos Aires F.D., C1430CKE
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CABA, C1119ACN
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Cipolletti, Río Negro Province, 8324
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Córdoba, 5000
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Córdoba, X5000AAJ
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Córdoba, X5000AAW
Novartis Investigative Site
Córdoba, X5000AAX
Novartis Investigative Site
Córdoba, X5000EPU
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Córdoba, X5000JJS
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Córdoba, X5003DCE
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Córdoba, X5003DCP
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Córdoba, X5006CBI
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Córdoba, X5009BSN
Novartis Investigative Site
Córdoba, X5022CPU
Novartis Investigative Site
Córdoba, X5220XAO
Novartis Investigative Site
Corrientes, W3400CBI
Novartis Investigative Site
Corrientes, W3400CLH
Novartis Investigative Site
Corrientes, W3400
Novartis Investigative Site
Corrientes, W3410AVV
Novartis Investigative Site
Formosa, P3600
Novartis Investigative Site
Formosa, P3634XAR
Novartis Investigative Site
Mar del Plata, Buenos Aires, 7600
Novartis Investigative Site
Mar del Plata, Buenos Aires, B7600
Novartis Investigative Site
Posadas, Misiones Province, N3300AHX
Novartis Investigative Site
Quilmes, Buenos Aires, B1878DVB
Novartis Investigative Site
Quilmes, Buenos Aires, B1878GEG
Novartis Investigative Site
Ramos Mejía, Buenos Aires, B1704ETD
Novartis Investigative Site
Rosario, Santa Fe Province, S2000CXP
Novartis Investigative Site
Rosario, Santa Fe Province, S2000DSV
Novartis Investigative Site
Rosario, Santa Fe Province, S2000
Novartis Investigative Site
Salta, 4400
Novartis Investigative Site
San Isidro, Buenos Aires, B1642DCD
Novartis Investigative Site
San Luis, D5702JRS
Novartis Investigative Site
San Miguel de Tucumán, San Miguel de Tucuman, T4000ICL
Novartis Investigative Site
San Miguel de Tucumán, Tucumán Province, T4000EBR
Novartis Investigative Site
San Miguel de Tucumán, Tucumán Province, T4000IFL
Novartis Investigative Site
San Miguel de Tucumán, Tucumán Province, T4000IIH
Novartis Investigative Site
San Miguel de Tucumán, T4000HXU
Novartis Investigative Site
San Nicolás de los Arroyos, Buenos Aires, B2900DMH
Novartis Investigative Site
San Salvador de Jujuy, Jujuy Province, Y4600ABF
Novartis Investigative Site
Santa Fe, S3000EOZ
Novartis Investigative Site
Santa Fe, S3000EPV
Novartis Investigative Site
Santa Fe, S3000FWO
Novartis Investigative Site
Santiago del Estero, G4200AQK
Novartis Investigative Site
Zárate, Buenos Aires, 2800
Russia48 sites
Novartis Investigative Site
Chelyabinsk, 454000
Novartis Investigative Site
Chelyabinsk, 454047
Novartis Investigative Site
Chelyabinsk, 454048
Novartis Investigative Site
Izhevsk, 426063
Novartis Investigative Site
Kazan', 420012
Novartis Investigative Site
Kemerovo, 650029
Novartis Investigative Site
Kirov, 610027
Novartis Investigative Site
Kirov, 610035
Novartis Investigative Site
Krasnodar, 350086
Novartis Investigative Site
Moscow, 111539
Novartis Investigative Site
Moscow, 117198
Novartis Investigative Site
Moscow, 117556
Novartis Investigative Site
Moscow, 119881
Novartis Investigative Site
Moscow, 125284
Novartis Investigative Site
Moscow, 127018
Novartis Investigative Site
Moscow, 127473
Novartis Investigative Site
Novosibirsk, 630087
Novartis Investigative Site
Penza, 440067
Novartis Investigative Site
Perm, 614097
Novartis Investigative Site
Perm, 614107
Novartis Investigative Site
Petrozavodsk, 185019
Novartis Investigative Site
Ryazan, 390026
Novartis Investigative Site
Saint Petersburg, 190013
Novartis Investigative Site
Saint Petersburg, 192257
Novartis Investigative Site
Saint Petersburg, 193163
Novartis Investigative Site
Saint Petersburg, 194044
Novartis Investigative Site
Saint Petersburg, 194295
Novartis Investigative Site
Saint Petersburg, 195067
Novartis Investigative Site
Saint Petersburg, 196084
Novartis Investigative Site
Saint Petersburg, 197022
Novartis Investigative Site
Saint Petersburg, 197110
Novartis Investigative Site
Saint Petersburg, 197341
Novartis Investigative Site
Saint Petersburg, 199106
Novartis Investigative Site
Samara, 443070
Novartis Investigative Site
Samara, 443096
Novartis Investigative Site
Saratov, 410012
Novartis Investigative Site
Saratov, 410028
Novartis Investigative Site
Sestroretsk, 197706
Novartis Investigative Site
Smolensk, 214018
Novartis Investigative Site
Syktyvkar, 167981
Novartis Investigative Site
Tomsk, 634012
Novartis Investigative Site
Tyumen, 625026
Novartis Investigative Site
Vladimir, 600020
Novartis Investigative Site
Yaroslavl, 150047
Novartis Investigative Site
Yekaterinburg, 620028
Novartis Investigative Site
Yekaterinburg, 620102
Novartis Investigative Site
Yekaterinburg, 620109
Novartis Investigative Site
Yekaterinburg, 620137
India46 sites
Novartis Investigative Site
Ahmedabad, Gujarat, 380 051
Novartis Investigative Site
Ahmedabad, Gujarat, 380006
Novartis Investigative Site
Ahmedabad, Gujarat, 380054
Novartis Investigative Site
Ahmedabad, Gujarat, 382428
Novartis Investigative Site
Ahmedabad, 380025
Novartis Investigative Site
Bangalore, Karnataka, 560 055
Novartis Investigative Site
Bengaluru, Karnataka, 560034
Novartis Investigative Site
Bikaner, Rajasthan, 334003
Novartis Investigative Site
Chennai, Tamil Nadu, 600081
Novartis Investigative Site
Coimbatore, Tamil Nadu, 641 018
Novartis Investigative Site
Coimbatore, Tamil Nadu, 641037
Novartis Investigative Site
Ghaziabad, Uttar Pradesh
Novartis Investigative Site
Guntur, Andhrapradesh, 522001
Novartis Investigative Site
Hyderabad, Andhra Pradesh, 500001
Novartis Investigative Site
Hyderabad, Andhra Pradesh
Novartis Investigative Site
Hyderabad, Telangana, 500 063
Novartis Investigative Site
Jaipur, Rajasthan, 302016
Novartis Investigative Site
Jaipur, Rajasthan, 302024
Novartis Investigative Site
Kochi, Kerala, 682 018
Novartis Investigative Site
Lucknow, Uttar Pradesh, 226005
Novartis Investigative Site
Ludhiana, Punjab, 141002
Novartis Investigative Site
Ludhiana, Punjab, 141012
Novartis Investigative Site
Ludhiana, Punjab, 141421
Novartis Investigative Site
Madurai, Tamil Nadu, 625107
Novartis Investigative Site
Manipal, Karnataka, 576104
Novartis Investigative Site
Mohali, Punjab, 160 062
Novartis Investigative Site
Nagpur, Maharashtra, 400012
Novartis Investigative Site
Nagpur, Maharashtra, 440 010
Novartis Investigative Site
Nagpur, Maharashtra, 44000033
Novartis Investigative Site
Nagpur, Maharashtra, 440012
Novartis Investigative Site
Nampally, Andhra Pradesh, 500 001
Novartis Investigative Site
Nashik, Maharashtra, 422 005
Novartis Investigative Site
Nellore, Andhra Pradesh, 524 003
Novartis Investigative Site
New Delhi, National Capital Territory of Delhi, 110060
Novartis Investigative Site
Pune, Maharashtra, 411004
Novartis Investigative Site
Pune, Maharashtra, 411005
Novartis Investigative Site
Rajasthan, Rajasthan, 324005
Novartis Investigative Site
Secunderabad, Telangana, 500003
Novartis Investigative Site
Surat, Gujarat, 395 002
Novartis Investigative Site
Surat, Gujarat, 395001
Novartis Investigative Site
Tirupati, Andhra Pradesh, 517 5-7
Novartis Investigative Site
Vadodara, Gujarat, 390015
Novartis Investigative Site
Varanasi, Uttar Pradesh, 224105
Novartis Investigative Site
Vijayawada, Andhra Pradesh, 520 008
Novartis Investigative Site
Vijayawada, Andhra Pradesh, 520010
Novartis Investigative Site
Visakhapatnam, Andhra Pradesh, 530 013
Japan42 sites
Novartis Investigative Site
Amagasaki, Hyōgo, 660 8550
Novartis Investigative Site
Amagasaki, Hyōgo, 661-0976
Novartis Investigative Site
Bunkyo-ku, Tokyo, 113-8603
Novartis Investigative Site
Chiyoda-ku, Tokyo, 101-8309
Novartis Investigative Site
Chiyoda-ku, Tokyo, 101-8643
Novartis Investigative Site
Fuchū, Tokyo, 183-0003
Novartis Investigative Site
Fujioka, Gunma, 375-8503
Novartis Investigative Site
Funabashi, Chiba, 273-8588
Novartis Investigative Site
Hatsukaichi, Hiroshima, 738 8503
Novartis Investigative Site
Higashiibaraki-gun, Ibaraki, 311-3193
Novartis Investigative Site
Hirakata, Osaka, 573-0153
Novartis Investigative Site
Hitachi, Ibaraki, 317-0077
Novartis Investigative Site
Ichinomiya, Aichi-ken, 491-8551
Novartis Investigative Site
Itabashi-ku, Tokyo, 173-8610
Novartis Investigative Site
Kasuga, Fukuoka, 816-0864
Novartis Investigative Site
Komatsushimachō, Tokushima, 773-8502
Novartis Investigative Site
Kumamoto, Kumamoto, 860-8556
Novartis Investigative Site
Kurume, Fukuoka, 830-8577
Novartis Investigative Site
Kusatsu, Shiga, 525-0014
Novartis Investigative Site
Kyoto, Kyoto, 607-8062
Novartis Investigative Site
Matsudo, Chiba, 270-2251
Novartis Investigative Site
Matsudo, Chiba, 271 0077
Novartis Investigative Site
Nagano, Nagano, 380 0814
Novartis Investigative Site
Nagoya, Aichi-ken, 453-8511
Novartis Investigative Site
Nishinomiya, Hyōgo, 663 8501
Novartis Investigative Site
Ōgaki, Gifu, 503-8502
Novartis Investigative Site
Onga-gun, Fukuoka, 807-0051
Novartis Investigative Site
Osaka, Osaka, 543-0035
Novartis Investigative Site
Osaka, Osaka, 543-8555
Novartis Investigative Site
Osaka, Osaka, 558-8558
Novartis Investigative Site
Sakaidechō, Kagawa-ken, 762-0007
Novartis Investigative Site
Sayama, Saitama, 350-1305
Novartis Investigative Site
Sendai, Miyagi, 980 8574
Novartis Investigative Site
Sendai, Miyagi, 983 8520
Novartis Investigative Site
Seto, Aichi-ken, 489-8642
Novartis Investigative Site
Takamatsu, Kagawa-ken, 760 8557
Novartis Investigative Site
Takarazuka, Hyōgo, 665-0022
Novartis Investigative Site
Takasaki, Gunma, 370-0036
Novartis Investigative Site
Takatsuki, Osaka, 569-0852
Novartis Investigative Site
Tokorozawa, Saitama, 359-1142
Novartis Investigative Site
Yokohama, Kanagawa, 234-0054
Novartis Investigative Site
Yukuhashi, Fukuoka, 824-0026
Canada38 sites
Novartis Investigative Site
Cambridge, Ontario, N1R 6V6
Novartis Investigative Site
Drummondville, Quebec, J2B 7T1
Novartis Investigative Site
Etobicoke, Ontario, M9V 4B4
Novartis Investigative Site
Gatineau, Quebec, J8Y 6S8
Novartis Investigative Site
Granby, Quebec, J2G 1T7
Novartis Investigative Site
Halifax, Nova Scotia, B3H 3A7
Novartis Investigative Site
Hamilton, Ontario, L8L 2X2
Novartis Investigative Site
Joliette, Quebec, J6E 6J2
Novartis Investigative Site
Kitchener, Ontario, N2M 5N4
Novartis Investigative Site
Lachine, Quebec, H8S 2E4
Novartis Investigative Site
Laval, Quebec, H7M 3L9
Novartis Investigative Site
Lévis, Quebec, G6V 4Z5
Novartis Investigative Site
Longueuil, Quebec, J4M 2X1
Novartis Investigative Site
Mississauga, Ontario, L5K 2L3
Novartis Investigative Site
Montreal, Quebec, H3G 1A4
Novartis Investigative Site
Montreal, Quebec, H4J 1C5
Novartis Investigative Site
Mount Pearl, Newfoundland and Labrador, A1N 1W7
Novartis Investigative Site
New Westminster, British Columbia, V3L 3W4
Novartis Investigative Site
Newmarket, Ontario, L3Y 2P7
Novartis Investigative Site
Newmarket, Ontario, L3Y 8C3
Novartis Investigative Site
Ottawa, Ontario, K1Y 4W7
Novartis Investigative Site
Peterborough, Ontario, K9J 0B2
Novartis Investigative Site
Québec, Quebec, G1G 3Y8
Novartis Investigative Site
Québec, Quebec, G1V 4G2
Novartis Investigative Site
Québec, Quebec, G3K 2P8
Novartis Investigative Site
Saint-Jean-sur-Richelieu, Quebec, J3A 1J2
Novartis Investigative Site
Sainte-Foy, Quebec, G1V 4G5
Novartis Investigative Site
Saskatoon, Saskatchewan, S7H 5M3
Novartis Investigative Site
Scarborough Village, Ontario, M1P 2V5
Novartis Investigative Site
Sherbrooke, Quebec, J1G-2E8
Novartis Investigative Site
Ste-Foy, Quebec, G1W 4R4
Novartis Investigative Site
Surrey, British Columbia, V3V 0C6
Novartis Investigative Site
Terrebonne, Quebec, J6V 2H2
Novartis Investigative Site
Thetford-Mines, Quebec, G6G 2V4
Novartis Investigative Site
Toronto, Ontario, M5B 1N9
Novartis Investigative Site
Toronto, Ontario, M9W 4L6
Novartis Investigative Site
Victoria, British Columbia, V8R4R2
Novartis Investigative Site
Winnipeg, Manitoba, R2V 4W3
Italy37 sites
Novartis Investigative Site
Ancona, AN, 60128
Novartis Investigative Site
Bergamo, BG, 24127
Novartis Investigative Site
Brescia, BS, 25123
Novartis Investigative Site
Casorate Primo, PV, 27022
Novartis Investigative Site
Catanzaro, CZ, 88100
Novartis Investigative Site
Chieti, CH, 66100
Novartis Investigative Site
Cona, FE, 44100
Novartis Investigative Site
Cortona, AR, 52044
Novartis Investigative Site
Fermo, AP, 63023
Novartis Investigative Site
Florence, FI, 50134
Novartis Investigative Site
Foggia, FG, 71100
Novartis Investigative Site
Massa, MS, 54100
Novartis Investigative Site
Milan, MI, 20100
Novartis Investigative Site
Milan, MI, 20132
Novartis Investigative Site
Milan, MI, 20145
Novartis Investigative Site
Monserrato, CA, 09042
Novartis Investigative Site
Montichiari, BS, 25018
Novartis Investigative Site
Naples, 80131
Novartis Investigative Site
Novara, 28100
Novartis Investigative Site
Palermo, PA, 90129
Novartis Investigative Site
Palmanova, UD, 33057
Novartis Investigative Site
Parma, PR, 43100
Novartis Investigative Site
Pavia, PV, 27100
Novartis Investigative Site
Piacenza, PC, 29100
Novartis Investigative Site
Pisa, PI, 56126
Novartis Investigative Site
Pozzilli, IS, 86077
Novartis Investigative Site
Roma, RM, 00161
Novartis Investigative Site
Roma, RM, 00168
Novartis Investigative Site
Roma, RM, 00189
Novartis Investigative Site
Rozzano, MI, 20089
Novartis Investigative Site
San Daniele del Friuli, UD, 33038
Novartis Investigative Site
Santa Maria Capua Vetere, CE, 81055
Novartis Investigative Site
Sassari, SS, 07100
Novartis Investigative Site
Soriano Calabro, VV, 89831
Novartis Investigative Site
Treviglio, BG, 24047
Novartis Investigative Site
Verona, VR, 37134
Novartis Investigative Site
Veruno, 28010
Brazil34 sites
Novartis Investigative Site
Belém, Pará, 66087-660
Novartis Investigative Site
Belo Horizonte, Minas Gerais, 30130-060
Novartis Investigative Site
Belo Horizonte, Minas Gerais, 30150-221
Novartis Investigative Site
Blumenau, Santa Catarina, 89020 430
Novartis Investigative Site
Brasília, Federal District, 70390-903
Novartis Investigative Site
Brasília, Federal District, 70658-700
Novartis Investigative Site
Campinas, São Paulo, 13010-001
Novartis Investigative Site
Campinas, São Paulo, 13020-431
Novartis Investigative Site
Campinas, São Paulo, 13060 080
Novartis Investigative Site
Campo Grande, Mato Grosso do Sul, 79080-190
Novartis Investigative Site
Curitiba, Paraná, 80730-150
Novartis Investigative Site
Fortaleza, Ceará, 60430 370
Novartis Investigative Site
Goiânia, Goiás, 74223-130
Novartis Investigative Site
Goiânia, Goiás, 74605-020
Novartis Investigative Site
Passo Fundo, Rio Grande do Sul, 99010-080
Novartis Investigative Site
Pelotas, Rio Grande do Sul, 96015-290
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90560-030
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90610-000
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90620 001
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90880-480
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 91350 200
Novartis Investigative Site
Recife, Pernambuco, 52051-380
Novartis Investigative Site
Salvador, Estado de Bahia, 40050-410
Novartis Investigative Site
Salvador, Estado de Bahia, 40140-110
Novartis Investigative Site
Santo André, São Paulo, 09190-615
Novartis Investigative Site
São José do Rio Preto, São Paulo, 15090 000
Novartis Investigative Site
São Paulo, São Paulo, 01323 000
Novartis Investigative Site
São Paulo, São Paulo, 04023-900
Novartis Investigative Site
São Paulo, São Paulo, 05403-000
Novartis Investigative Site
São Paulo, São Paulo, 05508-000
Novartis Investigative Site
Tatuí, São Paulo, 18270-170
Novartis Investigative Site
Uberlândia, Minas Gerais, 38405-320
Novartis Investigative Site
Uberlândia, Minas Gerais, 38411 186
Novartis Investigative Site
Votuporanga, São Paulo, 15500 003
China34 sites
Novartis Investigative Site
Baotou, Inner Mongolia, 014040
Novartis Investigative Site
Beijing, Beijing Municipality, 100730
Novartis Investigative Site
Beijing, 100010
Novartis Investigative Site
Beijing, 100028
Novartis Investigative Site
Beijing, 100029
Novartis Investigative Site
Beijing, 100034
Novartis Investigative Site
Beijing, 100038
Novartis Investigative Site
Beijing, 100176
Novartis Investigative Site
Changchun, Jilin, 130033
Novartis Investigative Site
Changsha, Hunan, 410003
Novartis Investigative Site
Chongqing, Chongqing Municipality, 400010
Novartis Investigative Site
Fuzhou, Fujian
Novartis Investigative Site
Guangzhou, Guangdong, 510000
Novartis Investigative Site
Guangzhou, Guangdong, 51000
Novartis Investigative Site
Hangzhou, Zhejiang, 310013
Novartis Investigative Site
Hangzhou, Zhejiang, 310016
Novartis Investigative Site
Harbin, Heilongjiang, 150000
Novartis Investigative Site
Nanjing, Jiangsu, 210009
Novartis Investigative Site
Nanning, Guangxi, 530021
Novartis Investigative Site
Shanghai, Shanghai Municipality, 200032
Novartis Investigative Site
Shanghai, Shanghai Municipality, 200120
Novartis Investigative Site
Shanghai, Shanghai Municipality
Novartis Investigative Site
Shanghai, 200080
Novartis Investigative Site
Shenyang, Liaoning, 110003
Novartis Investigative Site
Shenyang, Liaoning, 110016
Novartis Investigative Site
Shijiazhuang, Hebei, 050000
Novartis Investigative Site
Suzhou, Jiangsu, 215006
Novartis Investigative Site
Tianjin, Tianjin Municipality, 300121
Novartis Investigative Site
Tianjin, 300142
Novartis Investigative Site
Tianjin, 30045
Novartis Investigative Site
Wuhan, Hubei, 430022
Novartis Investigative Site
Wuhan, Hubei, 430060
Novartis Investigative Site
Xian, Shanxi, 710004
Novartis Investigative Site
Xian, Shanxi, 710061
United Kingdom34 sites
Novartis Investigative Site
Axbridge, Somerset, BS26 2BJ
Novartis Investigative Site
Barnet, EN5 3DJ
Novartis Investigative Site
Basingstoke, Hampshire, RG24 9NA
Novartis Investigative Site
Berkshire, RG2 0TG
Novartis Investigative Site
Birmingham, B15 2SQ
Novartis Investigative Site
Birmingham, B15 2TH
Novartis Investigative Site
Birmingham, B9 5SS
Novartis Investigative Site
Cardiff, Wales, CF5 4AD
Novartis Investigative Site
Cardiff, CF14 5GJ
Novartis Investigative Site
Cheshire, CW11 1EQ
Novartis Investigative Site
Chesterfield, S40 4AA
Novartis Investigative Site
Chorley, PR7 7NA
Novartis Investigative Site
Dundee, Perthshire, DD1 9SY
Novartis Investigative Site
Exeter, EX2 5DW
Novartis Investigative Site
Glasgow, G20 0SP
Novartis Investigative Site
Glasgow, G20 0XA
Novartis Investigative Site
Glasgow, G51 4TF
Novartis Investigative Site
Irvine, KA12 0AY
Novartis Investigative Site
Leicester, LE3 9QP
Novartis Investigative Site
Liverpool, L22 0LG
Novartis Investigative Site
London, EC14 7BE
Novartis Investigative Site
Manchester, M15 6SX
Novartis Investigative Site
Newcastle upon Tyne, NE7 7DN
Novartis Investigative Site
Newport, Isle Of Wight, PO30 5TG
Novartis Investigative Site
Newport, NP20 2UB
Novartis Investigative Site
Norwich, NR4 7UY
Novartis Investigative Site
Nottingham, NG5 1PB
Novartis Investigative Site
Salford, Manchester, M6 8HD
Novartis Investigative Site
Sheffield, S5 7AU
Novartis Investigative Site
Taunton, Somerset, TA1 5DA
Novartis Investigative Site
Whitby, North Yorkshire, Y021 1SD
Novartis Investigative Site
Wiltshire, SN15 2SB
Novartis Investigative Site
Worcester, WR5 1DD
Novartis Investigative Site
York, YO31 8HE
Romania32 sites
Novartis Investigative Site
Baia Mare, 430123
Novartis Investigative Site
Brăila, ROM, 810249
Novartis Investigative Site
Brasov, 500283
Novartis Investigative Site
Bucharest, District 1, 010225
Novartis Investigative Site
Bucharest, District 1
Novartis Investigative Site
Bucharest, District 2
Novartis Investigative Site
Bucharest, District 4, 4204179
Novartis Investigative Site
Bucharest, 011728
Novartis Investigative Site
Bucharest, 011774
Novartis Investigative Site
Bucharest, 021659
Novartis Investigative Site
Cluj-Napoca, Jud Cluj, 400015
Novartis Investigative Site
Cluj-Napoca, 400006
Novartis Investigative Site
Cluj-Napoca, 400347
Novartis Investigative Site
Constanța, Jud. Constanta, 900591
Novartis Investigative Site
Craiova, Jud. Dolj, 200497
Novartis Investigative Site
Craiova, 200642
Novartis Investigative Site
Iași, Jud Iasi, 700732
Novartis Investigative Site
Iași, Jud. Iasi, 700111
Novartis Investigative Site
Oradea, Jud Bihor, 410169
Novartis Investigative Site
Oradea, 410169
Novartis Investigative Site
Piteşti, Argeş, 110438
Novartis Investigative Site
Piteşti, 110084
Novartis Investigative Site
Sibiu, 550371
Novartis Investigative Site
Târgu Mureş, Jud Mures, 540043
Novartis Investigative Site
Târgu Mureş, Mureș County, 540124
Novartis Investigative Site
Târgu Mureş, 540096
Novartis Investigative Site
Târgu Mureş, 540136
Novartis Investigative Site
Târgu Mureş, 540142
Novartis Investigative Site
Tg Mures, Mureș County, 540136
Novartis Investigative Site
Timișoara, Timiș County, 300362
Novartis Investigative Site
Timișoara, 300310
Novartis Investigative Site
Timișoara, 300736
Czechia31 sites
Novartis Investigative Site
Benešov, 25601
Novartis Investigative Site
Brandýs nad Labem, Czech Republic, 250 01
Novartis Investigative Site
Brno-Bohunice, 625 00
Novartis Investigative Site
Broumov, 550 01
Novartis Investigative Site
Jablonec nad Nisou, Czech Republic, 466 01
Novartis Investigative Site
Kladno, Czech Republic, 272 80
Novartis Investigative Site
Kolín, 280 20
Novartis Investigative Site
Liberec, Czech Republic, 460 05
Novartis Investigative Site
Louny, Czech Republic
Novartis Investigative Site
Mariánské Lázně, 353 01
Novartis Investigative Site
Most, CZE, 434 01
Novartis Investigative Site
Ostrava, Czech Republic, 70200
Novartis Investigative Site
Pardubice, 530 02
Novartis Investigative Site
Pilsen, Czech Republic, 301 00
Novartis Investigative Site
Prague, Czech Republic, 148 00
Novartis Investigative Site
Prague, Czech Republic
Novartis Investigative Site
Prague, CZE, 128 08
Novartis Investigative Site
Prague, 12808
Novartis Investigative Site
Prague 4 - Krc, 14059
Novartis Investigative Site
Rožnov pod Radhoštěm, Czech Republic, 756 61
Novartis Investigative Site
Semily, Czech Republic, 513 31
Novartis Investigative Site
Slaný, 274 01
Novartis Investigative Site
Svitavy, Czech Republic, 568 25
Novartis Investigative Site
Teplice, 415 29
Novartis Investigative Site
Třebíč, Czech Republic, 674 01
Novartis Investigative Site
Trutnov, CZE, 46063
Novartis Investigative Site
Uherské Hradiště, 68601
Novartis Investigative Site
Ústí nad Labem, Czech Republic, 400 01
Novartis Investigative Site
Ústí nad Orlicí, Czech Republic, 562 18
Novartis Investigative Site
Vyškov, Czech Republic, 68001
Novartis Investigative Site
Znojmo, Czech Republic, 66902
Slovakia31 sites
Novartis Investigative Site
Banská Bystrica, 97401
Novartis Investigative Site
Bardejov, 085 01
Novartis Investigative Site
Bratislava, Slovak Republic, 826 06
Novartis Investigative Site
Bratislava, 81369
Novartis Investigative Site
Bratislava, 831 06
Novartis Investigative Site
Bratislava, 841 07
Novartis Investigative Site
Brezno, Slovak Republic, 977 42
Novartis Investigative Site
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About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Event-driven Trial of Quarterly Subcutaneous Canakinumab in the Prevention of Recurrent Cardiovascular Events Among Stable Post-myocardial Infarction Patients With Elevated hsCRP
Main Study (CACZ885M2301): The purpose of the pivotal phase of this trial was to test the hypothesis that canakinumab treatment of patients with myocardial infarction (MI) at least one month prior to study entry and elevated hsCRP could prevent recurrent cardiovascular events.
The purpose of the extension phase of the main study is to collect additional long-term safety data on continued exposure to canakinumab in patients who participated in the pivotal phase.
Read more
Sub-study 1 (CACZ885M2301S1): The purpose of this sub-study was to evaluate the effect of quarterly subcutaneous canakinumab treatment for 24 months comparted with placebo on the carotid plaque burden measured by integrated vascular MRI in patients enrolled in the CACZ885M2301 study (CANTOS).
Sub-study 2 (CACZ885M2301S2): The purpose of this CANTOS sub-study was to determine whether, in patients with type 2 diabetes participating in the CANTOS main study, canakinumab compared to placebo, on top of standard of care could increase insulin secretion and insulin sensitivity.
Read the detailed description
Sub-study 1 and 2 were terminated prior to data collection from subjects. However, there is an ongoing extension trial where patients are receiving open-drug label.
- Conditions
- Atherosclerosis
- Being tested
- Canakinumab, Placebo, Standard of care
- Keywords
- Cardiovascular Death, Myocardial Infarction, Stroke, Canakinumab, IL-1B, hsCRP
- Medical subject headings
- Atherosclerosis, Myocardial Infarction, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CanakinumabDrug
Also called ACZ885
PlaceboDrug
Standard of careDrug
Standard of care post-MI background therapy includes, but is not limited to, lipid lowering, anti-hypertensive, beta blockers, and anti-platelet therapy as appropriate
| Study group | Role | What they receive |
|---|---|---|
| Canakinumab Dose 50 mg | Experimental | Pivotal Phase:
Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care therapy.
Extension Phase:
Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care therapy Receives: Drug: Canakinumab; Drug: Standard of care |
| Canakinumab Dose 150 mg | Experimental | Pivotal Phase:
Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care therapy Receives: Drug: Canakinumab; Drug: Standard of care |
| Canakinumab Dose 300 mg | Experimental | Pivotal Phase:
Blinded Canakinumab 300 mg quarterly subcutaneous (with one additional dose at week 2) + standard of care therapy.
Extension phase:
Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care therapy Receives: Drug: Canakinumab; Drug: Standard of care |
| Placebo | Placebo comparator | Pivotal Phase:
Blinded matching placebo quarterly subcutaneous + standard of care therapy.
Extension Phase:
Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care therapy Receives: Drug: Placebo; Drug: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of Core Phase First CEC Confirmed Major Adverse Cardiovascular Events (MACE) and Its Components
Time to occurrence of CEC (Cardiovascular clinical events adjudication committee) confirmed MACE, which was a composite endpoint consisting of CEC confirmed CV death, CEC confirmed non-fatal MI,or CEC confirmed non-fatal stroke. Patients with the CEC adjudicated reason for death of "Unknown" were counted as CV (cardiovascular) death.
Measured: From randomization, to end of treatment plus 30 days, up to approximately 6 years
Substudy 1 (Core Phase): Change From Baseline in Carotid Plaque Burden in the Bifurcation Region of the Index Carotid Artery
Measured: 24 months
Substudy 2 (Core Phase): Change From Baseline of the Insulin Secretion Rate (ISR) Relative to Glucose 0-30 Min Defined as Φ30 = AUCISR 0-30 / AUCGluc 0-30 Averaged Across the Year 3, 4, 5 Visits
Measured: From randomization up to approximately 6 years
Secondary outcomes (14)
Patients With Core Phase CEC Confirmed CV Death, Non-fatal MI, Non-fatal Stroke, or Hospitalization for Unstable Angina Requiring Unplanned Revascularization
Occurrence of the composite cardiovascular endpoint consisting of cardiovascular death, non-fatal MI, non-fatal stroke or hospitalization for unstable angina requiring unplanned revascularization.
MACE includes CV death, non-fatal MI and non-fatal stroke. CEC = Clinical Endpoints Committee
Measured: From randomization, to end of treatment pus 30 days, up to approximately 6 years
Patients With Core Phase New Onset Type 2 Diabetes Among Patients With Pre-diabetes at Randomization
Time to CEC confirmed new onset of type 2 diabetes among those with pre-diabetes at randomization (i.e. excluding those that are normoglycemic at baseline)
Measured: From randomization up to approximately 6 years
Core Phase All-cause Mortality, Non-fatal MI, or Non-fatal Stroke
Occurrence of the composite endpoint consisting of all-cause mortality, non-fatal IM, or non-fatal stroke
Measured: From randomization, to end of treatment plus 30 days, up to approximately 6 years
Core Phase All-cause Mortality
Number of participant deaths
Measured: From randomization, to end of treatment plus 30 days, up to approximately 6 years
Summary of Adverse Events (Core Phase)
Summary of Adverse Events (AEs) and Serious Adverse Events (SAEs) occurring during the double-blind Core phase of the study. AEs/SAEs are any signs or symptoms that occur during the study treatment.
Measured: From randomization, to end of treatment plus 30 days, up to approximately 6 years
Summary of Adverse Events (Extension Phase)
Summary of Adverse Events (AEs) and Serious Adverse Events (SAEs) occurring during the Extension phase of the study. AEs/SAEs are any signs or symptoms that occur during the study treatment.
Measured: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years
Substudy 1 (Core Phase): Change From Baseline of the Total Vessel Wall Area at Month 3 in the Bifurcation Region of the Index Carotid Artery
Measured: 3 months
Substudy 1 (Core Phase): Mean Total Vessel Wall Area Across the Left and Right Carotid Artery at Month 3 and Month 24
Measured: 24 months
Substudy 1 (Core Phase): Change From Baseline in Corresponding Total Vessel Wall Area in the Left and Right Carotid Arteries
Measured: 24 months
Substudy 1 (Core Phase): The Existence of a Baseline Total Vessel Wall Area by Treatment Interaction as Well as the Consistency of the Treatment Effect Across Subgroups
Measured: 24 months
Substudy 2 (Core Phase): Change From Baseline in Insulin Sensitivity Index
Measured: From randomization up to approximately 6 years
Substudy 2 (Core Phase): Change From Baseline in OGTT Stimulated Area Under Curve (AUC) 0-120 Min of Glucose Concentration, Insulin Concentration, Pro-insulin Concentration, and Insulin Concentration/Glucose Concentration Ratio
Measured: From randomization up to approximately 6 years
Substudy 2 (Core Phase): Change From Baseline in Fasting Pro-Insulin Concentration/Insulin Concentration Ratio
Measured: From randomization up to approximately 6 years
Substudy 2 (Core Phase): Change From Baseline in OGTT Stimulated Area Under the Curve (AUC) 0-120 Min of C-peptide Concentration
Measured: From randomization up to approximately 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2011 (estimated)
- Study start11 Apr 2011
- Primary completion28 Mar 2017
- Study completion14 Apr 2019
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 (20)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10,066 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01327846
- Sponsor's protocol ID
- CACZ885M2301
- Other IDs
- 2010-022970-14
- Acronym
- CANTOS
- Status last verified
- Jan 2020
- First submitted
- 29 Mar 2011
- Last updated
- 22 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Publications
Scheidegger C, Wandel S, Mutze T. Covariate Adjustment for the Win Odds: Application to Cardiovascular Outcomes Trials. Stat Med. 2026 May;45(10-12):e70602. doi: 10.1002/sim.70602.
PubMed 42141513Woo J, Zhai T, Yang F, Xu H, Healey ML, Yates DP, Beste MT, Steensma DP. Effect of Clonal Hematopoiesis Mutations and Canakinumab Treatment on Incidence of Solid Tumors in the CANTOS Randomized Clinical Trial. Cancer Prev Res (Phila). 2024 Sep 4;17(9):429-436. doi: 10.1158/1940-6207.CAPR-23-0342.
PubMed 38701435Woo J, Lu D, Lewandowski A, Xu H, Serrano P, Healey M, Yates DP, Beste MT, Libby P, Ridker PM, Steensma DP. Effects of IL-1beta inhibition on anemia and clonal hematopoiesis in the randomized CANTOS trial. Blood Adv. 2023 Dec 26;7(24):7471-7484. doi: 10.1182/bloodadvances.2023011578.
PubMed 37934948Ridker PM, Tuttle KR, Perkovic V, Libby P, MacFadyen JG. Inflammation drives residual risk in chronic kidney disease: a CANTOS substudy. Eur Heart J. 2022 Dec 7;43(46):4832-4844. doi: 10.1093/eurheartj/ehac444.
PubMed 35943897Svensson EC, Madar A, Campbell CD, He Y, Sultan M, Healey ML, Xu H, D'Aco K, Fernandez A, Wache-Mainier C, Libby P, Ridker PM, Beste MT, Basson CT. TET2-Driven Clonal Hematopoiesis and Response to Canakinumab: An Exploratory Analysis of the CANTOS Randomized Clinical Trial. JAMA Cardiol. 2022 May 1;7(5):521-528. doi: 10.1001/jamacardio.2022.0386.
PubMed 35385050Everett BM, MacFadyen JG, Thuren T, Libby P, Glynn RJ, Ridker PM. Inhibition of Interleukin-1beta and Reduction in Atherothrombotic Cardiovascular Events in the CANTOS Trial. J Am Coll Cardiol. 2020 Oct 6;76(14):1660-1670. doi: 10.1016/j.jacc.2020.08.011.
PubMed 33004131Schieker M, Conaghan PG, Mindeholm L, Praestgaard J, Solomon DH, Scotti C, Gram H, Thuren T, Roubenoff R, Ridker PM. Effects of Interleukin-1beta Inhibition on Incident Hip and Knee Replacement : Exploratory Analyses From a Randomized, Double-Blind, Placebo-Controlled Trial. Ann Intern Med. 2020 Oct 6;173(7):509-515. doi: 10.7326/M20-0527. Epub 2020 Aug 4.
PubMed 32744862Vallurupalli M, MacFadyen JG, Glynn RJ, Thuren T, Libby P, Berliner N, Ridker PM. Effects of Interleukin-1beta Inhibition on Incident Anemia: Exploratory Analyses From a Randomized Trial. Ann Intern Med. 2020 Apr 21;172(8):523-532. doi: 10.7326/M19-2945. Epub 2020 Mar 24.
PubMed 32203978Rothman AM, MacFadyen J, Thuren T, Webb A, Harrison DG, Guzik TJ, Libby P, Glynn RJ, Ridker PM. Effects of Interleukin-1beta Inhibition on Blood Pressure, Incident Hypertension, and Residual Inflammatory Risk: A Secondary Analysis of CANTOS. Hypertension. 2020 Feb;75(2):477-482. doi: 10.1161/HYPERTENSIONAHA.119.13642. Epub 2019 Dec 30.
PubMed 31884854Ridker PM, MacFadyen JG, Thuren T, Libby P. Residual inflammatory risk associated with interleukin-18 and interleukin-6 after successful interleukin-1beta inhibition with canakinumab: further rationale for the development of targeted anti-cytokine therapies for the treatment of atherothrombosis. Eur Heart J. 2020 Jun 14;41(23):2153-2163. doi: 10.1093/eurheartj/ehz542.
PubMed 31504417Everett BM, Cornel JH, Lainscak M, Anker SD, Abbate A, Thuren T, Libby P, Glynn RJ, Ridker PM. Anti-Inflammatory Therapy With Canakinumab for the Prevention of Hospitalization for Heart Failure. Circulation. 2019 Mar 5;139(10):1289-1299. doi: 10.1161/CIRCULATIONAHA.118.038010.
PubMed 30586730Solomon DH, Glynn RJ, MacFadyen JG, Libby P, Thuren T, Everett BM, Ridker PM. Relationship of Interleukin-1beta Blockade With Incident Gout and Serum Uric Acid Levels: Exploratory Analysis of a Randomized Controlled Trial. Ann Intern Med. 2018 Oct 16;169(8):535-542. doi: 10.7326/M18-1167. Epub 2018 Sep 18.
PubMed 30242335Ridker PM, Libby P, MacFadyen JG, Thuren T, Ballantyne C, Fonseca F, Koenig W, Shimokawa H, Everett BM, Glynn RJ. Modulation of the interleukin-6 signalling pathway and incidence rates of atherosclerotic events and all-cause mortality: analyses from the Canakinumab Anti-Inflammatory Thrombosis Outcomes Study (CANTOS). Eur Heart J. 2018 Oct 7;39(38):3499-3507. doi: 10.1093/eurheartj/ehy310.
PubMed 30165610Ridker PM, MacFadyen JG, Glynn RJ, Koenig W, Libby P, Everett BM, Lefkowitz M, Thuren T, Cornel JH. Inhibition of Interleukin-1beta by Canakinumab and Cardiovascular Outcomes in Patients With Chronic Kidney Disease. J Am Coll Cardiol. 2018 May 29;71(21):2405-2414. doi: 10.1016/j.jacc.2018.03.490.
PubMed 29793629Everett BM, Donath MY, Pradhan AD, Thuren T, Pais P, Nicolau JC, Glynn RJ, Libby P, Ridker PM. Anti-Inflammatory Therapy With Canakinumab for the Prevention and Management of Diabetes. J Am Coll Cardiol. 2018 May 29;71(21):2392-2401. doi: 10.1016/j.jacc.2018.03.002. Epub 2018 Mar 12.
PubMed 29544870
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Event-driven Trial of Quarterly Subcutaneous Canakinumab in the Prevention of Recurrent Cardiovascular Events Among Stable Post-myocardial Infarction Patients With Elevated hsCRP
- ClinicalTrials.gov ID
- NCT01327846
- Acronym / sponsor ID
- CANTOS / CACZ885M2301
- Conditions
- Atherosclerosis
- Keywords
- Cardiovascular Death, Myocardial Infarction, Stroke, Canakinumab, IL-1B, hsCRP
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10,066 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2011 (actual)
- Primary completion
- 28 Mar 2017 (actual)
- Study completion
- 14 Apr 2019 (actual)
- First posted
- 4 Apr 2011 (estimated)
- Results
- Posted 22 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Main Study (CACZ885M2301): The purpose of the pivotal phase of this trial was to test the hypothesis that canakinumab treatment of patients with myocardial infarction (MI) at least one month prior to study entry and elevated hsCRP could prevent recurrent cardiovascular events.
The purpose of the extension phase of the main study is to collect additional long-term safety data on continued exposure to canakinumab in patients who participated in the pivotal phase.
Sub-study 1 (CACZ885M2301S1): The purpose of this sub-study was to evaluate the effect of quarterly subcutaneous canakinumab treatment for 24 months comparted with placebo on the carotid plaque burden measured by integrated vascular MRI in patients enrolled in the CACZ885M2301 study (CANTOS).
Sub-study 2 (CACZ885M2301S2): The purpose of this CANTOS sub-study was to determine whether, in patients with type 2 diabetes participating in the CANTOS main study, canakinumab compared to placebo, on top of standard of care could increase insulin secretion and insulin sensitivity.
Detailed description
Sub-study 1 and 2 were terminated prior to data collection from subjects. However, there is an ongoing extension trial where patients are receiving open-drug label.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Canakinumab Dose 50 mg | Experimental | Drug: Canakinumab, Drug: Standard of carePivotal Phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care therapy. Extension Phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care therapy |
| Canakinumab Dose 150 mg | Experimental | Drug: Canakinumab, Drug: Standard of carePivotal Phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care therapy |
| Canakinumab Dose 300 mg | Experimental | Drug: Canakinumab, Drug: Standard of carePivotal Phase: Blinded Canakinumab 300 mg quarterly subcutaneous (with one additional dose at week 2) + standard of care therapy. Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care therapy |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Standard of carePivotal Phase: Blinded matching placebo quarterly subcutaneous + standard of care therapy. Extension Phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| CanakinumabAlso: ACZ885 | Drug | Canakinumab Dose 150 mg, Canakinumab Dose 300 mg, Canakinumab Dose 50 mg |
| Placebo | Drug | Placebo |
| Standard of careStandard of care post-MI background therapy includes, but is not limited to, lipid lowering, anti-hypertensive, beta blockers, and anti-platelet therapy as appropriate | Drug | Canakinumab Dose 150 mg, Canakinumab Dose 300 mg, Canakinumab Dose 50 mg, Placebo |
Primary outcome
Analysis of Core Phase First CEC Confirmed Major Adverse Cardiovascular Events (MACE) and Its Components
Time frame: From randomization, to end of treatment plus 30 days, up to approximately 6 years
Time to occurrence of CEC (Cardiovascular clinical events adjudication committee) confirmed MACE, which was a composite endpoint consisting of CEC confirmed CV death, CEC confirmed non-fatal MI,or CEC confirmed non-fatal stroke. Patients with the CEC adjudicated reason for death of "Unknown" were counted as CV (cardiovascular) death.
Substudy 1 (Core Phase): Change From Baseline in Carotid Plaque Burden in the Bifurcation Region of the Index Carotid Artery
Time frame: 24 months
Substudy 2 (Core Phase): Change From Baseline of the Insulin Secretion Rate (ISR) Relative to Glucose 0-30 Min Defined as Φ30 = AUCISR 0-30 / AUCGluc 0-30 Averaged Across the Year 3, 4, 5 Visits
Time frame: From randomization up to approximately 6 years
14 secondary outcomes
Patients With Core Phase CEC Confirmed CV Death, Non-fatal MI, Non-fatal Stroke, or Hospitalization for Unstable Angina Requiring Unplanned Revascularization
Time frame: From randomization, to end of treatment pus 30 days, up to approximately 6 years
Patients With Core Phase New Onset Type 2 Diabetes Among Patients With Pre-diabetes at Randomization
Time frame: From randomization up to approximately 6 years
Core Phase All-cause Mortality, Non-fatal MI, or Non-fatal Stroke
Time frame: From randomization, to end of treatment plus 30 days, up to approximately 6 years
Core Phase All-cause Mortality
Time frame: From randomization, to end of treatment plus 30 days, up to approximately 6 years
Summary of Adverse Events (Core Phase)
Time frame: From randomization, to end of treatment plus 30 days, up to approximately 6 years
Summary of Adverse Events (Extension Phase)
Time frame: From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years
Substudy 1 (Core Phase): Change From Baseline of the Total Vessel Wall Area at Month 3 in the Bifurcation Region of the Index Carotid Artery
Time frame: 3 months
Substudy 1 (Core Phase): Mean Total Vessel Wall Area Across the Left and Right Carotid Artery at Month 3 and Month 24
Time frame: 24 months
Substudy 1 (Core Phase): Change From Baseline in Corresponding Total Vessel Wall Area in the Left and Right Carotid Arteries
Time frame: 24 months
Substudy 1 (Core Phase): The Existence of a Baseline Total Vessel Wall Area by Treatment Interaction as Well as the Consistency of the Treatment Effect Across Subgroups
Time frame: 24 months
Substudy 2 (Core Phase): Change From Baseline in Insulin Sensitivity Index
Time frame: From randomization up to approximately 6 years
Substudy 2 (Core Phase): Change From Baseline in OGTT Stimulated Area Under Curve (AUC) 0-120 Min of Glucose Concentration, Insulin Concentration, Pro-insulin Concentration, and Insulin Concentration/Glucose Concentration Ratio
Time frame: From randomization up to approximately 6 years
Substudy 2 (Core Phase): Change From Baseline in Fasting Pro-Insulin Concentration/Insulin Concentration Ratio
Time frame: From randomization up to approximately 6 years
Substudy 2 (Core Phase): Change From Baseline in OGTT Stimulated Area Under the Curve (AUC) 0-120 Min of C-peptide Concentration
Time frame: From randomization up to approximately 6 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42141513Scheidegger C, Wandel S, Mutze T. Covariate Adjustment for the Win Odds: Application to Cardiovascular Outcomes Trials. Stat Med. 2026 May;45(10-12):e70602. doi: 10.1002/sim.70602.
- Derived from this study: PubMed 38701435Woo J, Zhai T, Yang F, Xu H, Healey ML, Yates DP, Beste MT, Steensma DP. Effect of Clonal Hematopoiesis Mutations and Canakinumab Treatment on Incidence of Solid Tumors in the CANTOS Randomized Clinical Trial. Cancer Prev Res (Phila). 2024 Sep 4;17(9):429-436. doi: 10.1158/1940-6207.CAPR-23-0342.
- Derived from this study: PubMed 37934948Woo J, Lu D, Lewandowski A, Xu H, Serrano P, Healey M, Yates DP, Beste MT, Libby P, Ridker PM, Steensma DP. Effects of IL-1beta inhibition on anemia and clonal hematopoiesis in the randomized CANTOS trial. Blood Adv. 2023 Dec 26;7(24):7471-7484. doi: 10.1182/bloodadvances.2023011578.
- Derived from this study: PubMed 35943897Ridker PM, Tuttle KR, Perkovic V, Libby P, MacFadyen JG. Inflammation drives residual risk in chronic kidney disease: a CANTOS substudy. Eur Heart J. 2022 Dec 7;43(46):4832-4844. doi: 10.1093/eurheartj/ehac444.
- Derived from this study: PubMed 35385050Svensson EC, Madar A, Campbell CD, He Y, Sultan M, Healey ML, Xu H, D'Aco K, Fernandez A, Wache-Mainier C, Libby P, Ridker PM, Beste MT, Basson CT. TET2-Driven Clonal Hematopoiesis and Response to Canakinumab: An Exploratory Analysis of the CANTOS Randomized Clinical Trial. JAMA Cardiol. 2022 May 1;7(5):521-528. doi: 10.1001/jamacardio.2022.0386.
- Derived from this study: PubMed 33004131Everett BM, MacFadyen JG, Thuren T, Libby P, Glynn RJ, Ridker PM. Inhibition of Interleukin-1beta and Reduction in Atherothrombotic Cardiovascular Events in the CANTOS Trial. J Am Coll Cardiol. 2020 Oct 6;76(14):1660-1670. doi: 10.1016/j.jacc.2020.08.011.
- Derived from this study: PubMed 32744862Schieker M, Conaghan PG, Mindeholm L, Praestgaard J, Solomon DH, Scotti C, Gram H, Thuren T, Roubenoff R, Ridker PM. Effects of Interleukin-1beta Inhibition on Incident Hip and Knee Replacement : Exploratory Analyses From a Randomized, Double-Blind, Placebo-Controlled Trial. Ann Intern Med. 2020 Oct 6;173(7):509-515. doi: 10.7326/M20-0527. Epub 2020 Aug 4.
- Derived from this study: PubMed 32203978Vallurupalli M, MacFadyen JG, Glynn RJ, Thuren T, Libby P, Berliner N, Ridker PM. Effects of Interleukin-1beta Inhibition on Incident Anemia: Exploratory Analyses From a Randomized Trial. Ann Intern Med. 2020 Apr 21;172(8):523-532. doi: 10.7326/M19-2945. Epub 2020 Mar 24.
- Derived from this study: PubMed 31884854Rothman AM, MacFadyen J, Thuren T, Webb A, Harrison DG, Guzik TJ, Libby P, Glynn RJ, Ridker PM. Effects of Interleukin-1beta Inhibition on Blood Pressure, Incident Hypertension, and Residual Inflammatory Risk: A Secondary Analysis of CANTOS. Hypertension. 2020 Feb;75(2):477-482. doi: 10.1161/HYPERTENSIONAHA.119.13642. Epub 2019 Dec 30.
- Derived from this study: PubMed 31504417Ridker PM, MacFadyen JG, Thuren T, Libby P. Residual inflammatory risk associated with interleukin-18 and interleukin-6 after successful interleukin-1beta inhibition with canakinumab: further rationale for the development of targeted anti-cytokine therapies for the treatment of atherothrombosis. Eur Heart J. 2020 Jun 14;41(23):2153-2163. doi: 10.1093/eurheartj/ehz542.
- Derived from this study: PubMed 30586730Everett BM, Cornel JH, Lainscak M, Anker SD, Abbate A, Thuren T, Libby P, Glynn RJ, Ridker PM. Anti-Inflammatory Therapy With Canakinumab for the Prevention of Hospitalization for Heart Failure. Circulation. 2019 Mar 5;139(10):1289-1299. doi: 10.1161/CIRCULATIONAHA.118.038010.
- Derived from this study: PubMed 30242335Solomon DH, Glynn RJ, MacFadyen JG, Libby P, Thuren T, Everett BM, Ridker PM. Relationship of Interleukin-1beta Blockade With Incident Gout and Serum Uric Acid Levels: Exploratory Analysis of a Randomized Controlled Trial. Ann Intern Med. 2018 Oct 16;169(8):535-542. doi: 10.7326/M18-1167. Epub 2018 Sep 18.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1,131 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 Canakinumab in people with Atherosclerosis, run by Novartis Pharmaceuticals at 1,131 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?
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: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1,131 sites in United States, Germany, Argentina, Russia, India 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 22 Jan 2020). 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?
Analysis of Core Phase First CEC Confirmed Major Adverse Cardiovascular Events (MACE) and Its Components (time frame: From randomization, to end of treatment plus 30 days, up to approximately 6 years). The study lists 3 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 NCT01327846, which also lists 20 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 22 Jan 2020.