AzTrials
AzTrials

Venous ThromboembolismPhase 3MAGELLANNCT00571649

Venous Thromboembolic Event (VTE) Prophylaxis in Medically Ill Patients

A Phase 3 study testing Rivaroxaban (Xarelto, BAY59-7939) and Enoxaparin in people with Venous Thromboembolism, run by Bayer at 676 sites in 53 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will evaluate if extended therapy with oral rivaroxaban can prevent blood clots in the leg and lung that can occur with patients hospitalized for acute medical illness, and compare these results with those of the standard enoxaparin dose and duration regimen. The safety of rivaroxaban will also be studied. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Venous Thromboembolism
What is being tested?
Rivaroxaban (Xarelto, BAY59-7939) and Enoxaparin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
8,101 participants
Where
676 sitesin 53 countries
Study dates
Dec 2007to Nov 2010
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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female patients aged 40 years or more
  • Patients at risk of venous thromboembolic events being hospitalized for acute medical conditions as follows:
  • Heart failure, New York Heart Association (NYHA) class III or IV
  • Active cancer
  • Acute ischemic stroke
  • Acute infectious and inflammatory diseases, including acute rheumatic diseases
  • Acute respiratory insufficiency
  • Additional risk factor for VTE, including reduced mobility

Who cannot join

  • Conditions that contraindicate the use of antithrombotic therapy with the Low Molecular-Weight Heparin (LMWH) enoxaparin
  • Conditions that may increase the risk of bleeding, including intracranial hemorrhage
  • Required drugs or procedures which may interfere with the study treatment
  • Concomitant conditions or diseases which may increase the risk of study subjects or interfere with the study outcome
  • General conditions in which subjects are not suitable to participate in the study

Trial locations and contacts

676 sites in 53 countries.

676 sites in 53 countries

United States121 sites

  • Study site

    Anaconda, Montana, 59711-2718

  • Study site

    Anderson, Indiana, 46011

  • Study site

    Ann Arbor, Michigan, 48106

  • Study site

    Atlanta, Georgia, 30342

  • Study site

    Aventura, Florida, 33180

  • Study site

    Baltimore, Maryland, 21215

  • Study site

    Baltimore, Maryland, 21237

  • Study site

    Bethlehem, Pennsylvania, 18015

  • Study site

    Biddeford, Maine, 04005

  • Study site

    Birmingham, Alabama, 35209

  • Study site

    Birmingham, Alabama, 35235

  • Study site

    Boyton Beach, Florida, 33472

  • Study site

    Brooklyn, New York, 11215

  • Study site

    Buffalo, New York, 14215-3021

  • Study site

    Camp Hill, Pennsylvania, 17011

  • Study site

    Canton, Ohio, 44718

  • Study site

    Charleston, South Carolina, 29425

  • Study site

    Chicago, Illinois, 60611

  • Study site

    Chula Vista, California, 91911

  • Study site

    Clarksburg, West Virginia, 26301

  • Study site

    Clearwater, Florida, 33756

  • Study site

    Columbus, Ohio, 43215

  • Study site

    Corsicana, Texas, 75110

  • Study site

    Dallas, Texas, 75216-7167

  • Study site

    Danville, Pennsylvania, 17822

  • Study site

    Decatur, Georgia, 30030

  • Study site

    Delray Beach, Florida, 33445

  • Study site

    Denver, Colorado, 80204

  • Study site

    Des Moines, Iowa, 50314-2611

  • Study site

    Detroit, Michigan, 48201

  • Study site

    Detroit, Michigan, 48202

  • Study site

    Dothan, Alabama, 36301

  • Study site

    Duarte, California, 91010

  • Study site

    Durham, North Carolina, 27710

  • Study site

    Edinburg, Texas, 78539

  • Study site

    Elizabeth City, North Carolina, 27909

  • Study site

    Encinitas, California, 92024

  • Study site

    Everett, Washington, 98201

  • Study site

    Fargo, North Dakota, 58122

  • Study site

    Farmington, Connecticut, 06030

  • Study site

    Fort Gordon, Georgia, 30905

  • Study site

    Fort Lauderdale, Florida, 33334

  • Study site

    Fountain Valley, California, 92708

  • Study site

    Framingham, Massachusetts, 01702

  • Study site

    Fullerton, California, 92835

  • Office of Dr. John Simmons, MD

    Geneva, Alabama, 36340

  • Study site

    Glendale, California, 91206

  • Study site

    Grand Rapids, Michigan, 49525

  • Study site

    Great Falls, Montana, 59405

  • Study site

    Greensboro, North Carolina, 27403

  • Study site

    Hackensack, New Jersey, 07601-1991

  • Study site

    Hollywood, Florida, 33021

  • Study site

    Houston, Texas, 77024

  • Study site

    Houston, Texas, 77030-4009

  • Study site

    Houston, Texas, 77030

  • Study site

    Idaho Falls, Idaho, 83404

  • Study site

    Jamaica, New York, 11418

  • Study site

    Jupiter, Florida, 33458

  • Study site

    Kansas City, Missouri, 64128

  • Study site

    Lafayette, Louisiana, 70503

  • Study site

    Lansing, Michigan, 48910

  • Study site

    Little Rock, Arkansas, 72205

  • Study site

    Maumee, Ohio, 43537-1899

  • Study site

    McAllen, Texas, 78503

  • Study site

    Memphis, Tennessee, 38104

  • Study site

    Miami, Florida, 33136

  • Study site

    Miami, Florida, 33173-3259

  • Study site

    Miami Springs, Florida, 33166

  • Study site

    Minneapolis, Minnesota, 55417

  • Study site

    Mobile, Alabama, 36608

  • Study site

    Montgomery, Alabama, 36111

  • Study site

    Nashville, Tennessee, 37232-2650

  • Study site

    New Brunswick, New Jersey, 08901

  • Study site

    New Hyde Park, New York, 11040-1496

  • Study site

    New Orleans, Louisiana, 70121

  • Study site

    New York, New York, 10011

  • Study site

    New York, New York, 10065

  • Study site

    Newark, Delaware, 19718

  • Study site

    Noblesville, Indiana, 46060

  • Study site

    Oceanside, California, 92056

  • Study site

    Ogden, Utah, 84403

  • Study site

    Olathe, Kansas, 66061

  • Study site

    Omaha, Nebraska, 68131

  • Study site

    Pasadena, California, 91105

  • Study site

    Pembroke Pines, Florida, 33024

  • Study site

    Petoskey, Michigan, 49770-2297

  • Study site

    Philadelphia, Pennsylvania, 19107

  • Study site

    Philadelphia, Pennsylvania, 19124

  • Study site

    Pontiac, Michigan, 48341

  • Study site

    Port Charlotte, Florida, 33952

  • Study site

    Pueblo, Colorado, 81003

  • Study site

    Redlands, California, 92373

  • Study site

    Richmond, Virginia, 23249

  • Study site

    Richmond, Virginia, 23298

  • Study site

    Rockport, Maine, 04856

  • Study site

    Sacramento, California, 95817

  • Study site

    Saint Clair Shores, Michigan, 48081

  • Study site

    San Antonio, Texas, 78218

  • Study site

    San Diego, California, 92120

  • Study site

    Santa Barbara, California, 93102

  • Study site

    Sarasota, Florida, 34232

  • Study site

    Savannah, Georgia, 31405

  • Study site

    Scranton, Pennsylvania, 18510

  • Study site

    Shreveport, Louisiana, 71130-4228

  • Study site

    Somerville, New Jersey, 08876-2598

  • Study site

    Springfield, Illinois, 62702

  • Study site

    St Louis, Missouri, 63110

  • Study site

    St Louis, Missouri, 63141

  • Study site

    Stony Brook, New York, 11794

  • Study site

    Summit, New Jersey, 07901

  • Study site

    Tacoma, Washington, 98405

  • Study site

    Teaneck, New Jersey, 07666

  • Study site

    Toledo, Ohio, 43606

  • Study site

    Torrance, California, 90502-2004

  • Study site

    Tuscaloosa, Alabama, 35401

  • Study site

    Tuscaloosa, Alabama, 35406

  • Study site

    Valhalla, New York, 10595

  • Study site

    Vero Beach, Florida, 32960

  • Study site

    Washington D.C., District of Columbia, 20037

  • Study site

    Wheat Ridge, Colorado, 80033-6017

  • Study site

    Wilkes-Barre, Pennsylvania, 18711-3752

Other trials in United States

Japan34 sites

  • Study site

    Amagasaki, Hyōgo, 660-8511

  • Study site

    Chikushino-shi, Fukuoka, 818-8516

  • Study site

    Daitō, Osaka, 574-0074

  • Study site

    Ebina, Kanagawa, 243-0433

  • Study site

    Fukui-shi, Fukui, 910-8561

  • Study site

    Hakodate, Hokkaido, 040-8611

  • Study site

    Hamamatsu, Shizuoka, 432-8580

  • Study site

    Hanamaki, Iwate, 025-0075

  • National Hospital Organization Ibaraki Higashi Hospital

    Ibaraki, Ibaraki, 319-1113

  • Study site

    Ichinomiya, Aichi-ken, 491-8551

  • Study site

    Kamakura, Kanagawa, 247-8533

  • Study site

    Kanazawa, Ishikawa-ken, 920-8650

  • Study site

    Kashiwazaki, Niigata, 945-8585

  • Study site

    Kasugai, Aichi-ken, 487-0013

  • Study site

    Kumamoto, Kumamoto, 860-0008

  • Study site

    Kure, Hiroshima, 737-0023

  • Study site

    Kusatsu, Shiga, 525-8585

  • Study site

    Kyoto, Kyoto, 606-8507

  • Study site

    Matsusaka, Mie-ken, 515-8544

  • Study site

    Matsuyama, Ehime, 790-0024

  • Study site

    Meguro-ku, Tokyo, 152-8902

  • Study site

    Nangoku, Kochi, 783-8509

  • Study site

    Ōbu, Aichi-ken, 474-8511

  • Study site

    Sapporo, Hokkaido, 065-0033

  • Study site

    Shimonoseki, Yamaguchi, 750-0061

  • Study site

    Shinjuku-ku, Tokyo, 162-8655

  • Study site

    Takasaki, Gunma, 370-0829

  • Study site

    Tomigusuku, Okinawa, 901-0243

  • Study site

    Tōon, Ehime, 791-0281

  • Study site

    Tsu, Mie-ken, 514-1101

  • Study site

    Tsu, Mie-ken, 514-8507

  • Study site

    Urasoe, Okinawa, 901-2132

  • Study site

    Yao, Osaka, 581-0011

  • Study site

    Yokohama, Kanagawa, 236-0051

Other trials in Japan

China32 sites

  • Study site

    Beijing, 100005

  • Study site

    Beijing, 100020

  • Study site

    Beijing, 100029

  • Study site

    Beijing, 100034

  • Study site

    Beijing, 100037

  • Study site

    Beijing, 100044

  • Beijing Friendship Hosp.

    Beijing, 100050

  • Study site

    Beijing, 100050

  • Study site

    Beijing, 100053

  • Study site

    Beijing, 100088

  • Study site

    Beijing, 100853

  • Study site

    Changchun, Jilin

  • Study site

    Changsha, Hunan, 410013

  • Study site

    Chengdu, Sichuan, 610041

  • Study site

    Chongqing, 400038

  • Study site

    Chongqing, 400042

  • Study site

    Dalian, Liaoning, 116027

  • Study site

    Guangzhou, Guangdong, 510120

  • Study site

    Guangzhou, Guangdong, 510405

  • Study site

    Guangzhou, Guangdong

  • Study site

    Nanjing, Jiangsu, 210008

  • Study site

    Nanjing, Jiangsu

  • Study site

    Shanghai, 200003

  • Study site

    Shanghai, 200025

  • Study site

    Shanghai, 200127

  • Study site

    Shanghai, 200233

  • Study site

    Shanghai

  • Study site

    Shenyang, Liaoning, 110001

  • Study site

    Shenyang, Liaoning, 110004

  • Study site

    Shenyang, Liaoning, 110015

  • The 1st Affiliated Hosp of the 4th Military Med Uni

    Xi'an, Shaanxi, 710032

  • 1st Affiliated Hosp., Med College Xi'an Jiaotong Univ.

    Xi'an, Shaanxi, 710061

Other trials in China

Germany31 sites

  • Study site

    Bad Mergentheim, Baden-Wurttemberg, 97980

  • Study site

    Beeskow, Brandenburg, 15848

  • Study site

    Berlin, State of Berlin, 10787

  • Study site

    Bremen, Free Hanseatic City of Bremen, 28177

  • Study site

    Cologne, North Rhine-Westphalia, 50935

  • Study site

    Cologne, North Rhine-Westphalia, 51067

  • Study site

    Cologne, North Rhine-Westphalia, 51109

  • Study site

    Dortmund, North Rhine-Westphalia, 44137

  • Study site

    Dresden, Saxony, 01067

  • Study site

    Dresden, Saxony, 01307

  • Study site

    Esslingen am Neckar, Baden-Wurttemberg, 73730

  • Study site

    Frankfurt (Oder), Brandenburg, 15236

  • Study site

    Halle, Saxony-Anhalt, 06112

  • Study site

    Heidelberg, Baden-Wurttemberg, 69120

  • Study site

    Jülich, North Rhine-Westphalia, 52428

  • Study site

    Karlsbad, Baden-Wurttemberg, 76307

  • Study site

    Leipzig, Saxony, 04289

  • Study site

    Leverkusen, North Rhine-Westphalia, 51375

  • Study site

    Mainz, Rhineland-Palatinate, 55131

  • Study site

    Mönchengladbach, North Rhine-Westphalia, 41063

  • Study site

    Neuss, North Rhine-Westphalia, 41464

  • Study site

    Neuwied, Rhineland-Palatinate, 56564

  • Study site

    Oberhausen, North Rhine-Westphalia, 46045

  • Study site

    Paderborn, North Rhine-Westphalia, 33098

  • Study site

    Pirna, Saxony, 01796

  • Study site

    Soest, North Rhine-Westphalia, 59494

  • Study site

    Stolberg, North Rhine-Westphalia, 52222

  • Study site

    Troisdorf, North Rhine-Westphalia, 53844

  • Study site

    Viersen, North Rhine-Westphalia, 41749

  • Study site

    Weiden, Bavaria, 92637

  • Study site

    Wuppertal, North Rhine-Westphalia, 42109

Other trials in Germany

France28 sites

  • Study site

    Arras, 62000

  • Study site

    Besançon, 25000

  • Study site

    Brest, 29609

  • Study site

    Castelnau-le-Lez, 34170

  • Study site

    Clermont-Ferrand, 63000

  • Study site

    Colombes, 92701

  • Study site

    Dijon, 21000

  • Study site

    Lille, 59037

  • Study site

    Lille, 59307

  • Study site

    Limoges, 87042

  • Study site

    Lomme, 59160

  • Study site

    Lyon, 69003

  • Study site

    Montpellier, 34295

  • Study site

    Nice, 06280

  • Study site

    Nîmes, 30029

  • Study site

    Paris, 75004

  • Study site

    Paris, 75010

  • Study site

    Paris, 75475

  • Study site

    Paris, 75877

  • Study site

    Pierre-Bénite, 69495

  • Study site

    Reims, 51092

  • Study site

    Roubaix, 59100

  • Study site

    Saint-Etienne, 42000

  • Study site

    Saint-Herblain, 44805

  • Study site

    Strasbourg, 67091

  • Study site

    Toulouse, 31403

  • Study site

    Tourcoing, 59208

  • Study site

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Italy25 sites

  • Study site

    Acquaviva delle Fonti, Bari, 70021

  • Study site

    Bergamo, 24128

  • Study site

    Campobasso, Molise, 86100

  • Study site

    Catania, Sicily, 95124

  • Study site

    Domodossola, Verbano-Cusio-Ossola, 28845

  • Study site

    Fidenza, Parma, 43036

  • Study site

    Genoa, Liguria, 16128

  • Study site

    Latina, 04100

  • Study site

    Milan, Lombardy, 20089

  • Study site

    Milan, Lombardy, 20133

  • Study site

    Milan, Lombardy, 20162

  • Study site

    Modena, Emilia-Romagna, 41100

  • Study site

    Naples, Campania, 80123

  • Study site

    Palermo, Sicily, 90127

  • Study site

    Parma, Emilia-Romagna, 43100

  • Study site

    Perugia, Umbria, 06024

  • Study site

    Perugia, Umbria, 06156

  • Study site

    Piacenza, Emilia-Romagna, 29121

  • Study site

    Reggio Calabria, 89124

  • Study site

    Reggio Emilia, Emilia-Romagna, 42123

  • Study site

    Rome, Lazio, 00161

  • Study site

    Rome, Lazio, 00168

  • Study site

    Terni, Trentino-Alto Adige, 05019

  • Study site

    Varese, Lombardy, 21100

  • Study site

    Vicenza, 36100

Other trials in Italy

Canada19 sites

  • Study site

    Calgary, Alberta, T2N 2T9

  • Study site

    Cobourg, Ontario, K9A 5W6

  • Study site

    Edmonton, Alberta, T5H 3V9

  • Study site

    Edmonton, Alberta, T6G 2B7

  • Study site

    Edmonton, Alberta, T6L 5X8

  • Study site

    Greenfield Park, Quebec, J4V 2H1

  • CHUM - Hopital Notre-Dame

    Montreal, Quebec, H2L 4M1

  • Study site

    Montreal, Quebec, H2L 4M1

  • Study site

    Montreal, Quebec, H2W 1T8

  • Study site

    Montreal, Quebec, H3T 1M5

  • Study site

    Ottawa, Ontario, K1Y 4E9

  • Study site

    Québec, Quebec, G1J 1Z4

  • Study site

    Québec, Quebec, G1V 4G5

  • Study site

    Saint John, New Brunswick, E2L 4L2

  • Study site

    Scarborough Village, Ontario, M1P 2V5

  • Study site

    Ste-Foy, Quebec, G1V 4G5

  • Study site

    Toronto, Ontario, M5T 2S8

  • Study site

    Vancouver, British Columbia, V5Z 1M9

  • Hotel Dieu-Grace Hospital

    Windsor, Ontario, N9A 1E1

Other trials in Canada

Mexico18 sites

  • Study site

    Aguascalientes, Aguascalientes, 20234

  • Study site

    Chihuahua City, Chihuahua, 31350

  • Study site

    Guadalajara, Jalisco, 44280

  • Study site

    Hermosillo, Sonora, 83000

  • Study site

    Mérida, Yucatán, 97001

  • Study site

    Metepec, State of Mexico, 52140

  • Study site

    Mexico City, Mexico City, 11340

  • Study site

    Mexico City, Mexico City, 15900

  • Study site

    Mexico D. F., Mexico City, 06760

  • Study site

    México, D.F, Mexico City, 07460

  • Study site

    México, D.F., Mexico City, 06729

  • Study site

    México, D.F., Mexico City, 07760

  • Study site

    Monterrey, Nuevo León, 66480

  • Study site

    Morelia, Michoacán, 58270

  • Study site

    Puebla City, Puebla, 72410

  • Study site

    Torreón, Coahuila, 27250

  • Study site

    Tuxtla Gutiérrez, Chiapas, 29000

  • Study site

    Zacatecas City, Zacatecas, 98000

Other trials in Mexico

Australia17 sites

  • Study site

    Adelaide, South Australia, 5042

  • Study site

    Auchenflower, Queensland, 4066

  • Study site

    Box Hill, Victoria, 3128

  • Study site

    Brisbane, Queensland, 4066

  • Study site

    Brisbane, Queensland, 4101

  • Study site

    Clayton, Victoria, 3168

  • Study site

    Garran, Australian Capital Territory, 2605

  • Study site

    Kogarah, New South Wales, 2217

  • Study site

    Launceston, Tasmania, 7250

  • Study site

    Lismore, New South Wales, 2480

  • Study site

    Melbourne, Victoria, 3135

  • Study site

    Melbourne, Victoria, 3144

  • Study site

    Perth, Western Australia, 6000

  • Study site

    Redcliffe, Queensland, 4020

  • Study site

    Southport, Queensland, 4215

  • Study site

    Sydney, New South Wales, 2229

  • Study site

    Woollongabba, Queensland, 4102

Other trials in Australia

Austria17 sites

  • Study site

    Gratwein, Styria, 8113

  • Study site

    Graz, Styria, 8036

  • Study site

    Hartberg, Styria, 8230

  • Study site

    Innsbruck, 6020

  • Study site

    Kittsee, Burgenland, 2421

  • Study site

    Leoben, Styria, 8700

  • Study site

    Linz, Upper Austria, 4020

  • Study site

    Linz, 4020

  • Study site

    Mürzzuschlag, 8680

  • Study site

    Oberpullendorf, Burgenland, 7350

  • Study site

    Sankt Pölten, 3100

  • Study site

    Vienna, State of Vienna, 1030

  • Study site

    Vienna, State of Vienna, 1100

  • Study site

    Vienna, 1100

  • Study site

    Vienna, 1140

  • Study site

    Wolfsberg, Carinthia, 9400

  • Study site

    Zams, Tyrol, 6511

Other trials in Austria

Belgium16 sites

  • Study site

    Aalst, 9300

  • Study site

    Bruges, 8000

  • Study site

    Bruxelles - Brussel, 1000

  • Study site

    Dendermonde, 9200

  • Study site

    Hasselt, 3500

  • Study site

    Huy, 4500

  • Study site

    Ieper, 8900

  • Study site

    Leuven, 3000

  • Study site

    Malmedy, 4960

  • Study site

    Mol, 2400

  • Study site

    Montigny S/sambre, 6061

  • Study site

    Mortsel, 2640

  • Study site

    Roeselare, 8800

  • Study site

    Sint-Niklaas, 9100

  • Study site

    Tubize, 1480

  • Study site

    Turnhout, 2300

Other trials in Belgium

India16 sites

  • Study site

    Ahmedabad, Gujar?t, 380 054

  • Study site

    Bangalore, Karn?taka, 560052

  • Study site

    Bangalore, Karn?taka, 560099

  • Study site

    Calicut, Kerala, 673 004

  • Study site

    Chennai, Tamil N?du, 600081

  • Study site

    Coimbatore, Tamil N?du, 641 004

  • Study site

    Hyderabad, 500034

  • Study site

    Hyderabad, 500082

  • Study site

    Hyderabad, 600 038

  • Study site

    Kolkata, West Bengal, 700 099

  • Study site

    Ludhiana, Punjab, 141001

  • Study site

    Mumbai, 400022

  • Study site

    Noida

  • Study site

    Pune, Maharashtra, 411001

  • Study site

    Pune, Maharashtra, 411011

  • Study site

    Thiruvananthapuram, Kerala, 695002

Other trials in India

Poland15 sites

  • Study site

    Bialystok, 15-276

  • Study site

    Bydgoszcz, 85-681

  • Study site

    Krakow, 31-066

  • Study site

    Krakow, 31-121

  • Study site

    Lublin, 20-178

  • Study site

    Olsztyn, 10-228

  • Study site

    Piotrkow Trybunalski, 97-300

  • Study site

    Siedlce, 08-110

  • Study site

    Starogard Gdański, 83-200

  • Study site

    Szczecin, 70-965

  • Study site

    Tarnów, 33-100

  • Study site

    Warsaw, 03-401

  • Study site

    Warsaw, 04-141

  • Study site

    Warsaw, 04-749

  • Study site

    Włocławek, 87-800

Other trials in Poland

Ukraine15 sites

  • Study site

    Donetsk, 83003

  • Study site

    Donetsk, 83045

  • Study site

    Ivano-Frankivsk, 76000

  • Study site

    Kharkiv, 61037

  • Study site

    Kharkiv, 61070

  • Study site

    Kharkiv, 61178

  • Study site

    Kiev, 02 091

  • Study site

    Kiev, 03680

  • Study site

    Kiev, 04112

  • Study site

    Kyiv, 01105

  • Study site

    Lviv, 790 34

  • Study site

    Odesa, 65009

  • Study site

    Odesa, 65025

  • Study site

    Simferopol, 95 026

  • Study site

    Simferopol, 95023

Other trials in Ukraine

South Africa14 sites

  • Study site

    Bloemfontein, Freestate, 9301

  • Study site

    Goodwood, Western Cape, 7460

  • Study site

    Johannesburg, Gauteng, 2057

  • Study site

    Johannesburg, Gauteng, 2132

  • Study site

    Johannesburg, Gauteng, 2196

  • Study site

    Kempton Park, Gauteng, 1610

  • Study site

    Pretoria, Gauteng, 0084

  • Study site

    Pretoria, Gauteng, 0157

  • Study site

    Pretoria, Gauteng, 0181

  • Study site

    Roodepoort, Gauteng, 1724

  • Study site

    Sandton, Gauteng, South Africa, 2196

  • Study site

    Somerset West, Western Cape, 7130

  • Study site

    Stellenbosch, Western Cape, 7505

  • Study site

    Worcester, Western Cape, 6850

Other trials in South Africa

Portugal13 sites

  • Study site

    Amadora, 2720-276

  • Study site

    Cascais, 2750-349

  • Study site

    Coimbra, 3000-075

  • Study site

    Lisbon, Lisbon District, 1150-199

  • Study site

    Lisbon, Lisbon District, 1649-035

  • Study site

    Lisbon, 1349-019

  • Study site

    Lisbon, 1849- 017

  • Study site

    Matosinhos Municipality, 4454-509

  • Study site

    Porto, Porto District, 4099-001

  • Study site

    Porto, 4200-319

  • Study site

    S. Martinho Do Bispo, Coimbra District, 3041-856

  • Study site

    Santarém, Santarém District, 2005

  • Study site

    Viana do Castelo, 4901-585

Other trials in Portugal

Spain13 sites

  • Study site

    Badalona, Barcelona, 08916

  • Study site

    Barcelona, Barcelona, 08023

  • Study site

    Barcelona, Barcelona, 08036

  • Study site

    Cabra, Córdoba, 14940

  • Study site

    Cartagena, Murcia, 30202

  • Study site

    Córdoba, Córdoba, 14004

  • Study site

    Cuenca, Cuenca, 16002

  • Study site

    Girona, Girona, 17007

  • Study site

    Olot, Girona, 17800

  • Study site

    Sabadell, Barcelona, 08208

  • Study site

    Vélez, Málaga, 29700

  • Study site

    Vigo, Pontevedra, 36214

  • Study site

    Zaragoza, Zaragoza, 50009

Other trials in Spain

Hungary12 sites

  • Study site

    Baja, 6500

  • Study site

    Balassagyarmat, 2660

  • Study site

    Budapest, 1076

  • Study site

    Budapest, 1134

  • Study site

    Budapest, 1145

  • Study site

    Debrecen, 4012

  • Study site

    Győr, 9024

  • Study site

    Hódmezővásárhely, 6800

  • Study site

    Kecskemét, 6000

  • Study site

    Székesfehérvár, 8000

  • Study site

    Tatabánya, 2800

  • Study site

    Zalaegerszeg-Pozva, H-8900

Other trials in Hungary

Russia12 sites

  • Study site

    Moscow, 103030

  • Study site

    Moscow, 115093

  • Study site

    Moscow, 115516

  • Study site

    Moscow, 117292

  • Study site

    Moscow, 119048

  • Study site

    Moscow, 119435

  • Study site

    Moscow, 125101

  • Study site

    Moscow, 125367

  • Study site

    Nizhny Novgorod, 603001

  • Study site

    Nizhny Novgorod, 603035

  • Study site

    Yaroslavl, 150003

  • Study site

    Yaroslavl, 150030

Other trials in Russia

Sweden12 sites

  • Study site

    Borås, 501 82

  • Study site

    Hässleholm, 281 25

  • Study site

    Karlshamn, 374 80

  • Study site

    Kristianstad, 29185

  • Study site

    Lund, 221 85

  • Study site

    Malmö, 205 02

  • Study site

    Skövde, 541 85

  • Study site

    Stockholm, 171 76

  • Study site

    Stockholm, 182 88

  • Study site

    Sundsvall, 851 86

  • Study site

    Umeå, 90185

  • Study site

    Visby, 62184

Other trials in Sweden

United Kingdom11 sites

  • Study site

    Dumfries, Dumfries and Galloway, DG1 4EP

  • Study site

    Glasgow, Stratchclyde, G11 6NT

  • Study site

    Leeds, West Yorkshire, LS9 7TF

  • Study site

    Liverpool, Merseyside, L9 7JU

  • Study site

    London, London, N18 1QX

  • Study site

    London, London, SE5 9RS

  • Study site

    London, W1T 4EU

  • Study site

    Middlesbrough, Cleveland, TS4 3BW

  • Study site

    Newcastle upon Tyne, Tyne and Wear, NE1 4LP

  • Study site

    Nottingham, NG7 2UH

  • Study site

    Sheffield, South Yorkshire, S10 2JF

Other trials in United Kingdom

Czechia10 sites

  • Study site

    Brno, 656 91

  • Study site

    Kutná Hora, 284 30

  • Study site

    Nové Město na Moravě, 592 31

  • Study site

    Olomouc, 775 20

  • Study site

    Pilsen, 305 99

  • Study site

    Prague, 128 08

  • Study site

    Prague, 128 21

  • Study site

    Prague, 12808

  • Study site

    Říčany, 251 49

  • Study site

    Znojmo, 669 02

Other trials in Czechia

Lithuania10 sites

  • Study site

    Kaunas, LT-3000

  • Study site

    Kaunas, LT-3002

  • Study site

    Kaunas, LT-3026

  • Study site

    Klaipėda, LT-5800

  • Study site

    Klaipėda, LT-92231

  • Study site

    Šiauliai, 76231

  • Study site

    Utena, LT-28142

  • Study site

    Vilnius, 04130

  • Study site

    Vilnius, 10207

  • Study site

    Vilnius, LT-2001

Other trials in Lithuania

Greece9 sites

  • Study site

    Abelokipi - Athens, 115 26

  • Study site

    Athens, 106 76

  • Study site

    Athens, 115 26

  • Study site

    Athens, 156 69

  • Study site

    Elefsina, Attica, 19018

  • Study site

    Kifisia / Athens, Attica, 14561

  • Study site

    Nea Ionia, 14233

  • Study site

    Piraeus, 18536

  • Study site

    Rio / Patras, 265 04

Other trials in Greece

Israel9 sites

  • Study site

    Afula, 1834111

  • Study site

    Ashkelon, 7830604

  • Study site

    Haifa, 31048

  • Study site

    Haifa, 3109601

  • Study site

    Holon, 58100

  • Study site

    Kfar Saba, 4428164

  • Study site

    Rehovot, 7610001

  • Study site

    Safed, 1311001

  • Study site

    Tel Aviv, 64239

Other trials in Israel

Netherlands9 sites

  • Study site

    Amersfoort, 3816 CP

  • Study site

    Amsterdam, 1061 AE

  • Study site

    Enschede, 7511 JX

  • Study site

    Heerlen, 6401 CX

  • Study site

    Maastricht, 6229 HX

  • Study site

    Nieuwegein, 3435 CM

  • Study site

    Rotterdam, 3083 AN

  • Study site

    Sittard, 6131 BK

  • Study site

    Utrecht, 3582 KE

Other trials in Netherlands

Switzerland9 sites

  • Study site

    Baden, 5404

  • Study site

    Basel, Canton of Basel-City, 4031

  • Study site

    Bern, Canton of Bern, 3010

  • Study site

    Bruderholz, Basel-Landschaft, 4101

  • Study site

    Geneva, Canton of Geneva, 1211

  • Study site

    Langenthal, Canton of Bern, 4901

  • Study site

    Liestal, Canton of Basel-City, 4410

  • Study site

    Lucerne, 6000

  • Study site

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

Argentina8 sites

  • Study site

    Avellaneda, Buenos Aires, B1870CID

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, 1221

  • Hospital Británico

    Buenos Aires, Ciudad Auton. de Buenos Aires, 1280

  • Sanatorio Mitre

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1039AAO

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1431FWO

  • Study site

    San Miguel, Buenos Aires, 1663

  • Hospital de Agudos "Dr. Carlos Bocalandro"

    Tres de Febrero, Buenos Aires, 1657

  • Study site

    Vicente López, 1638

Other trials in Argentina

Brazil8 sites

  • Study site

    Campinas, São Paulo, 130839 970

  • Study site

    Curitiba, Paraná, 80050-350

  • Study site

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Study site

    Santo André, São Paulo, 09190-610

  • Study site

    São Paulo, São Paulo, 01323-001

  • Study site

    São Paulo, São Paulo, 04039 002

  • Study site

    São Paulo, São Paulo, 05403-900

  • Study site

    São Paulo, São Paulo, 05443000

Other trials in Brazil

Finland8 sites

  • Study site

    Hämeenlinna, 13530

  • Study site

    Helsinki, 00290

  • Study site

    Jyväskylä, 40620

  • Study site

    Lahti, 15850

  • Study site

    Lappeenranta, 53130

  • Study site

    Raisio, 21200

  • Study site

    Turku, 20520

  • Study site

    Turku, 20700

Other trials in Finland

Latvia8 sites

  • Study site

    Daugavpils, LV-5417

  • Study site

    Liepāja, 3402

  • Study site

    Riga, 1002

  • Study site

    Riga, 1005

  • Study site

    Riga, LV-1001

  • Study site

    Riga, LV-1038

  • Study site

    Valmiera, LV-4201

  • Study site

    Ventspils, LV-3601

Other trials in Latvia

Bulgaria7 sites

  • Study site

    Pleven, 5800

  • Study site

    Rousse, 7002

  • Study site

    Sofia, 1233

  • Study site

    Sofia, 1606

  • Study site

    Stara Zagora, 6000

  • Study site

    Varna, 9010

  • Study site

    Veliko Tarnovo, 5000

Other trials in Bulgaria

South Korea7 sites

  • Study site

    Gyeonggi-do, 463-712

  • Study site

    Gyeongi-do, Korea, 463-707

  • Study site

    Jeollanam-do, 519-763

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi, 110-744

  • Seoul Metropolitan Boramae Hospital

    Seoul, Seoul Teugbyeolsi, 156-707

  • Study site

    Seoul, 135-710

  • Study site

    Seoul, 138736

Other trials in South Korea

Colombia6 sites

  • Study site

    Bogotá, Bogota D.C.

  • Study site

    Bogotá

  • Study site

    Cali, Valle del Cauca Department

  • Study site

    Cali

  • Study site

    Medellín, Antioquia

  • Study site

    Medellín

Other trials in Colombia

Denmark6 sites

  • Study site

    Esbjerg, 6700

  • Study site

    Frederiksberg C, 2000

  • Study site

    København NV, 2400

  • Study site

    København S, 2300

  • Study site

    Kolding, 6000

  • Study site

    Roskilde, 4000

Other trials in Denmark

Peru6 sites

  • Study site

    Callao, CALLAO 2

  • Study site

    Lima, 01

  • Study site

    Lima, 31

  • Study site

    Lima, LIMA 11

  • Study site

    Lima, LIMA 1

  • Study site

    Lima Cercado, LIMA 1

Other trials in Peru

Croatia5 sites

  • Study site

    Osijek, 310 00

  • Study site

    Rijeka, 51000

  • Study site

    Zadar, 23000

  • Study site

    Zagreb, 10000

  • Study site

    Zagreb, 1000

Other trials in Croatia

Norway5 sites

  • Study site

    Fredrikstad, 1603

  • Study site

    Gjøvik, 2819

  • Study site

    Hamar, 2326

  • Study site

    Oslo, 0319

  • Study site

    Oslo, 0407

Other trials in Norway

Romania5 sites

  • Study site

    Bucharest, 014461

  • Study site

    Bucharest, 022328

  • Study site

    Bucharest, 041915

  • Study site

    Constanța, 900591

  • Study site

    Suceava, 720237

Other trials in Romania

Singapore5 sites

  • Study site

    Singapore, 119074

  • Study site

    Singapore, 168752

  • Study site

    Singapore, 169608

  • Study site

    Singapore, 308433

  • Changi General Hospital

    Singapore, 529889

Other trials in Singapore

Slovakia5 sites

  • Study site

    Bratislava, 813 69

  • Study site

    Bratislava, 826 06

  • Study site

    Lučenec, 984 39

  • Study site

    Martin, 036 59

  • Study site

    Žilina, 012 07

Other trials in Slovakia

Taiwan5 sites

  • Study site

    Kaohsiung City, 833

  • Study site

    Tainan, 710

  • Study site

    Taipei, 10016

  • Study site

    Taipei, 114

  • Study site

    Taipei

Other trials in Taiwan

Estonia4 sites

  • Study site

    Tallinn, 10138

  • Study site

    Tallinn, 13419

  • Study site

    Tallinn, EE-10617

  • Study site

    Tartu, EE-51014

Other trials in Estonia

New Zealand4 sites

  • Study site

    Auckland, 0622

  • Study site

    Auckland, 1023

  • Study site

    Auckland, 2024

  • Study site

    Christchurch, 8011

Other trials in New Zealand

Turkey (Türkiye)4 sites

  • Study site

    Istanbul, 34098

  • Study site

    Istanbul, 34304

  • Study site

    Izmir, 35100

  • Study site

    Izmir, 35340

Other trials in Turkey (Türkiye)

Chile3 sites

  • Study site

    Santiago, 760 0448

  • Study site

    Santiago

  • Study site

    Viña del Mar

Other trials in Chile

Indonesia3 sites

  • Study site

    Jakarta, 10430

  • Study site

    Jakarta, 11420

  • Study site

    Surabaya, 60286

Other trials in Indonesia

Luxembourg3 sites

  • Study site

    Luxembourg, 1210

  • Study site

    Luxembourg-Kirchberg, 2540

  • Study site

    Niedercorn, 4602

Other trials in Luxembourg

Malaysia3 sites

  • Study site

    Kuala Lumpur, 59100

  • Study site

    Negeri Sembilan,, 70300

  • Study site

    Sarawak, 93400

Other trials in Malaysia

Pakistan3 sites

  • Study site

    Karachi, 74800

  • Study site

    Karachi, 75500

  • Study site

    Lahore

Other trials in Pakistan

Slovenia3 sites

  • Study site

    Golnik, 4204

  • Study site

    Ljubljana, 1000

  • Study site

    Novo Mesto, 8000

Other trials in Slovenia

Thailand3 sites

  • Study site

    Bangkok, Thailand, 10700

  • Study site

    Bangkok, 10400

  • Study site

    Chiang Mai, 50200

Other trials in Thailand

Hong Kong2 sites

  • Study site

    Shatin, N.t.

  • Study site

    Shatin

Other trials in Hong Kong

About this study

Official title: Multicenter, Randomized, Parallel-group Efficacy and Safety Study for the Prevention of Venous Thromboembolism in Hospitalized Medically Ill Patients Comparing Rivaroxaban With Enoxaparin. The MAGELLAN Study

This study will evaluate if extended therapy with oral rivaroxaban can prevent blood clots in the leg and lung that can occur with patients hospitalized for acute medical illness, and compare these results with those of the standard enoxaparin dose and duration regimen. The safety of rivaroxaban will also be studied.

Read the detailed description

The treatment period was followed by a follow-up period starting the day after the last intake of study medication, regardless of the actual duration of study drug administration and ended on Day 90 (+ 7 days). Participants who did not complete the treatment period also entered the follow-up period. It was also possible that participants did not enter the follow-up period, e.g. due to withdrawal of consent or termination of study participation.

Within the US 'Johnson \& Johnson Pharmaceutical Research \& Development, L.L.C.' is sponsor.

Being tested
Rivaroxaban (Xarelto, BAY59-7939), Enoxaparin, Rivaroxaban placebo, Enoxaparin placebo
Keywords
Acute medical illnesses with increased risk for VTE., Deep vein thrombosis (DVT), Pulmonary embolism (PE),, Venous Thromboembolic disease (VTE),, Medical illness
Medical subject headings
Venous Thromboembolism, Venous Thrombosis, Pulmonary Embolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rivaroxaban (Xarelto, BAY59-7939)Drug

    Oral rivaroxaban 10 mg once daily administered for 35 +/- 4 days

  • EnoxaparinDrug

    Subcutaneous enoxaparin 40 mg once daily (OD) administered for 10 +/- 4 days

  • Rivaroxaban placeboDrug

    Oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days

  • Enoxaparin placeboDrug

    Subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days

Study groups in NCT00571649
Study groupRoleWhat they receive
Rivaroxaban (Xarelto, BAY59-7939)ExperimentalParticipants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939); Drug: Enoxaparin placebo
EnoxaparinActive comparatorParticipants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
Receives: Drug: Enoxaparin; Drug: Rivaroxaban placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Composite Endpoint of Venous Thromboembolism [VTE] (Any Deep Vein Thrombosis [DVT], Non Fatal Pulmonary Embolism [PE]) and VTE-related Death up to Day 35 + 6 Days

    A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.

    Measured: Up to Day 35 + 6 days

  2. Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days

    A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.

    Measured: Up to Day 10 + 5 days

Secondary outcomes (12)

  1. Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and All-cause Mortality up to Day 35 + 6 Days

    A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and death (VTE-related and not VTE-related).

    Measured: Up to Day 35 + 6 days

  2. Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days Per mITT Population

    A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.

    Measured: Up to Day 10 + 5 days

  3. Percentage of Participants With VTE Combined With All-cause Mortality up to Day 10 + 5 Days

    A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and death (VTE-related and not VTE-related).

    Measured: Up to Day 10 + 5 days

  4. Percentage of Participants With Symptomatic VTE, Including and Excluding VTE-related Death up to Days 10, 35, and 90

    Symptomatic VTE (non-fatal PE and DVT in lower extremity), including and excluding VTE-related death (PE and PE cannot be excluded) up to Days 10, 35, and 90

    Measured: At Day 10 + 5 days, at Day 35 + 6 days, and at Day 90 + 7 days

  5. Percentage of Participants With Net Clinical Benefit (Any DVT, Non-fatal PE, VTE-related Death, Plus Major and Clinically Relevant Non-major Bleeding Events) up to Day 35 + 6 Days

    Net clinical benefit is a composite of the primary efficacy endpoint (asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death) plus major and clinically relevant non-major bleeding events.

    Measured: Up to Day 35 + 6 days

  6. Percentage of Participants With Net Clinical Benefit (Any DVT, Non-fatal PE, VTE-related Death, Plus Major and Clinically Relevant Non-major Bleeding Events) up to Day 10 + 5 Days

    Net clinical benefit is a composite of the primary efficacy endpoint (asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death) plus major and clinically relevant non-major bleeding events

    Measured: Up to Day 10 + 5 days

  7. Percentage of Participants With Major Vascular Events up to Days 10, 35, and 90

    Major vascular events included cardiovascular death, acute myocardial infarction (MI), or acute ischemic stroke. Participants may have had a vascular event in more than one category.

    Measured: At Day 10 + 5 days, at Day 35 + 6 days, and at Day 90 + 7 days

  8. Percentage of Participants With Each Component of the Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 35 + 6 Days

    The components of the composite endpoint include asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.

    Measured: Up to Day 35 + 6 days

  9. Percentage of Participants With Each Component of the Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days

    The components of the composite endpoint include asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.

    Measured: Up to Day 10 + 5 days

  10. Percentage of Participants With All-cause Mortality up to Day 90 + 7 Days

    All deaths, including VTE-related deaths, cardiovascular deaths, and other deaths.

    Measured: Up to Day 90 + 7 days

  11. Percentage of Participants With the Composite of Treatment Emergent Major Bleeding Events and Non-major Clinically Relevant Bleeding Events up to 2 Days After Last Intake of Any Study Medication (Day 35 + 6 Days)

    Major bleeding events were defined as events leading to >=2 g/dL fall in hemoglobin; or transfusion of >= 2 units of packed RBCs (Red blood cells) or whole blood; or leading to death. Non-major bleeding events were defined as overt bleeding not meeting the criteria of major bleeding

    Measured: Up to Day 35 + 6 days

  12. Percentage of Participants With the Composite of Treatment Emergent Major Bleeding Events and Non-major Clinically Relevant Bleeding Events up to 2 Days After Last Application of a Study Medication Syringe (Day 10 + 5 Days)

    Major bleeding events were defined as events leading to >=2 g/dL fall in hemoglobin or transfusion of >=2 units of packed RBCs or whole blood or leading to death. Non-major bleeding events were defined as overt bleeding not meeting the criteria of major bleeding.

    Measured: Up to Day 10 + 5 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2007 (estimated)
  2. Study startDec 2007
  3. Primary completionAug 2010
  4. Study completionNov 2010

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
8,101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00571649
Sponsor's protocol ID
12839
Other IDs
2007-004614-14
Acronym
MAGELLAN
Status last verified
Aug 2016
First submitted
11 Dec 2007
Last updated
15 Sep 2016
Data monitoring committee
Yes

Publications

  • Cohen AT, Spiro TE, Buller HR, Haskell L, Hu D, Hull R, Mebazaa A, Merli G, Schellong S, Spyropoulos A, Tapson V. Extended-duration rivaroxaban thromboprophylaxis in acutely ill medical patients: MAGELLAN study protocol. J Thromb Thrombolysis. 2011 May;31(4):407-16. doi: 10.1007/s11239-011-0549-x.

    PubMed 21359646

  • Cohen AT, Spiro TE, Buller HR, Haskell L, Hu D, Hull R, Mebazaa A, Merli G, Schellong S, Spyropoulos AC, Tapson V; MAGELLAN Investigators. Rivaroxaban for thromboprophylaxis in acutely ill medical patients. N Engl J Med. 2013 Feb 7;368(6):513-23. doi: 10.1056/NEJMoa1111096.

    PubMed 23388003

  • Sharma A, Chatterjee S, Lichstein E, Mukherjee D. Extended thromboprophylaxis for medically ill patients with decreased mobility: does it improve outcomes? J Thromb Haemost. 2012 Oct;10(10):2053-60. doi: 10.1111/j.1538-7836.2012.04874.x.

    PubMed 22863355

  • Mebazaa A, Spiro TE, Buller HR, Haskell L, Hu D, Hull R, Merli G, Schellong SW, Spyropoulos AC, Tapson VF, De Sanctis Y, Cohen AT. Predicting the risk of venous thromboembolism in patients hospitalized with heart failure. Circulation. 2014 Jul 29;130(5):410-8. doi: 10.1161/CIRCULATIONAHA.113.003126. Epub 2014 Jun 26.

    PubMed 24970782

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rivaroxaban (Xarelto, BAY59-7939) and Enoxaparin in people with Venous Thromboembolism, run by Bayer at 676 sites in 53 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 8 inclusion and 5 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: finished, as of the sponsor's last update on 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 676 sites in United States, Japan, China, Germany, France and 48 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. 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 Jun 2012). 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?

Percentage of Participants With Composite Endpoint of Venous Thromboembolism [VTE] (Any Deep Vein Thrombosis [DVT], Non Fatal Pulmonary Embolism [PE]) and VTE-related Death up to Day 35 + 6 Days (time frame: Up to Day 35 + 6 days). 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 NCT00571649, which also lists 12 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 15 Sep 2016.

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