AzTrials
AzTrials

Venous ThrombosisPhase 3NCT00643201

Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism

A Phase 3 study testing Enoxaparin and warfarin in people with Venous Thrombosis, run by Bristol-Myers Squibb at 381 sites in 31 countries.

Completed

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

Official record
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Trial summary

The purpose of this study is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients with deep vein thrombosis (DVT) or pulmonary embolism (PE) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Venous Thrombosis
What is being tested?
Enoxaparin and warfarin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
5,614 participants
Where
381 sitesin 31 countries
Study dates
Jul 2008to Mar 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women ≥ 18 years of age
  • Clinical diagnosis of DVT or PE

Who cannot join

  • Contraindications for enoxaparin or warfarin
  • Active bleeding or high risk for serious bleeding
  • Short life expectancy
  • Uncontrolled high blood pressure
  • Significantly impaired kidney or liver function

Trial locations and contacts

381 sites in 31 countries.

381 sites in 31 countries

United States73 sites

  • Pulmonary & Critical Care Services, Pc

    Albany, New York, 12205

  • Anne Arundel Medical Center

    Annapolis, Maryland, 21401

  • Atlanta Pulmonary Group

    Atlanta, Georgia, 30342

  • R Adams Cowley Shock Trauma Center

    Baltimore, Maryland, 21201

  • Medstar Research Health Institute

    Baltimore, Maryland, 21237

  • Beaver Medical Group

    Banning, California, 92220

  • Bay Pines Va Healthcare Systems

    Bay Pines, Florida, 33744

  • Lake Washington Vascular, Pllc

    Bellevue, Washington, 98004

  • Alabama Clinical Therapeutics, Llc

    Birmingham, Alabama, 35235

  • Daniel G. Lorch, Jr, Md, Cpi

    Brandon, Florida, 33511

  • Bridgeport Hospital

    Bridgeport, Connecticut, 06610

  • Holston Medical Group

    Bristol, Tennessee, 37620

  • Kaleida Health System

    Buffalo, New York, 14209

  • Mercury Street Medical Group, Pllc

    Butte, Montana, 59701

  • Infectious Disease Of Indiana Psc

    Carmel, Indiana, 46032

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • Research Alliance, Inc.

    Clearwater, Florida, 33756

  • Huron Hospital

    Cleveland, Ohio, 44112

  • University Of Missouri-Columbia

    Columbia, Missouri, 65212

  • Remington Davis Inc.

    Columbus, Ohio, 43215

  • Atlanta Institute For Medical Research, Inc

    Decatur, Georgia, 30030

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Fort Smith Lung Center

    Fort Smith, Arkansas, 72901

  • University Of California San Francisco-Fresno

    Fresno, California, 93701

  • New West Physicians

    Golden, Colorado, 80401

  • Altru Health System Clinic

    Grand Forks, North Dakota, 58201

  • Internal Medical Associates Of Grand Island, P.C

    Grand Island, Nebraska, 68803

  • Great Falls Clinic, Llp

    Great Falls, Montana, 59405

  • Greenville Hospital System

    Greenville, South Carolina, 29615

  • Kentucky Lung Clinic

    Hazard, Kentucky, 41701

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Primecare Medical Group

    Houston, Texas, 77024

  • Kore Cv Research

    Jackson, Tennessee, 38305

  • River City Clinical Research

    Jacksonville, Florida, 32207

  • Gateway Cardiology. P.C

    Jerseyville, Illinois, 62052

  • Veterans Affairs Medical Center

    Kansas City, Missouri, 64128

  • Univ. Of Kentucky Dept. Of Surgery

    Lexington, Kentucky, 40536

  • University Of Arkansas For Medical Sciences

    Little Rock, Arkansas, 72205

  • Horizon Research Group, Inc.

    Mobile, Alabama, 36608

  • Morristown Memorial Hospital

    Morristown, New Jersey, 07962

  • Dept Of Internal Med, Sect Of Pulmonary & Critical Care Med

    New Haven, Connecticut, 06510

  • West Suburban Medical Center

    Oak Park, Illinois, 60302

  • Creighton University Medical Center

    Omaha, Nebraska, 68131

  • Research Integrity, Llc

    Owensboro, Kentucky, 42303

  • Mississippi Medical Research, Llc

    Picayune, Mississippi, 39466

  • Oregon Health Science University

    Portland, Oregon, 97239

  • Rex Healthcare

    Raleigh, North Carolina, 27607

  • Pen Bay Medical Center

    Rockport, Maine, 04856

  • University Of California, Davis Medical Center

    Sacramento, California, 95817

  • University Of Utah Medical Center

    Salt Lake City, Utah, 84132

  • Cancer Care Centers Of South Texas

    San Antonio, Texas, 78229

  • Chest Medicine & Critical Care Medical Gr. Inc.

    San Diego, California, 92123

  • Chatham Hospitalists

    Savannah, Georgia, 31405

  • Washington University School Of Medicine

    St Louis, Missouri, 63110

  • St. John'S Mercy Medical Center

    St Louis, Missouri, 63141

  • Pasadena Center For Medical Research

    St. Petersburg, Florida, 33707

  • Stanford University Medical Center

    Stanford, California, 94305

  • Richmond University Medical Center

    Staten Island, New York, 10310

  • Piedmont Healthcare/Research

    Statesville, North Carolina, 28625

  • Palmetto Clinical Research

    Summerville, South Carolina, 29485

  • Franciscan Research Center

    Tacoma, Washington, 98405

  • Tampa Clinical Research

    Tampa, Florida, 33624

  • Harbor Ucla Medical Center

    Torrance, California, 90509

  • New York Medical College

    Valhalla, New York, 10595

  • Office Of Michele S. Maholtz Md

    Vero Beach, Florida, 32960

  • George Washington University Medical Faculty Associates

    Washington D.C., District of Columbia, 20037

  • Cleveland Clinic Florida

    Weston, Florida, 33331

  • Drogue Medical, Llc

    Wheat Ridge, Colorado, 80033

  • Wilmington Medical Research

    Wilmington, North Carolina, 28401

  • Heartland Vascular Medicine And Surgery

    Windsor Heights, Iowa, 50324

  • Clinical Trials Of America, Inc.

    Winston-Salem, North Carolina, 27103

Other trials in United States

Russia23 sites

  • Local Institution

    Arkhangelsk, 163045

  • Local Institution

    Chelyabinsk, 454136

  • Local Institution

    Kazan', 420101

  • Local Institution

    Moscow, 109386

  • Local Institution

    Moscow, 111539

  • Local Institution

    Moscow, 115093

  • Local Institution

    Moscow, 115280

  • Local Institution

    Moscow, 117292

  • Local Institution

    Moscow, 119049

  • Local Institution

    Moscow, 121359

  • Local Institution

    Moscow, 121552

  • Local Institution

    Moscow, 127473

  • Local Institution

    Novosibirsk, 630090

  • Local Institution

    Rostov-on-Don, 344022

  • Local Institution

    Ryazan, 390026

  • Local Institution

    Saint Petersburg, 192242

  • Local Institution

    Saint Petersburg, 194044

  • Local Institution

    Saint Petersburg, 196247

  • Local Institution

    Saint Petersburg, 197022

  • Local Institution

    Saint Petersburg, 197341

  • Local Institution

    Saint Petersburg, 199106

  • Local Institution

    Saratov, 410012

  • Local Institution

    Yaroslavl, 150062

Other trials in Russia

Brazil19 sites

  • Local Institution

    Belo Horizonte - Mg, Minas Gerais, 30150

  • Local Institution

    Botucatu, São Paulo, 18618

  • Local Institution

    Curitiba, Paraná, 80035

  • Local Institution

    Curitiba, Paraná, 80050

  • Local Institution

    Curitiba, Paraná, 80810

  • Local Institution

    Curitiba, Paraná, 81520

  • Local Institution

    Liberdade, São Paulo, 01509

  • Local Institution

    Port Alegre, Rio Grande do Sul, 90020

  • Local Institution

    Porto Alegre, Rio Grande do Sul, 90035

  • Local Institution

    Porto Alegre, Rio Grande do Sul, 90110

  • Local Institution

    Porto Alegre, Rio Grande do Sul, 90610

  • Local Institution

    Rio de Janeiro, Rio de Janeiro, 20551

  • Local Institution

    Rio Janeiro, Rio de Janeiro, 22280

  • Local Institution

    São Bernardo do Campo, São Paulo, 09715

  • Local Institution

    São José do Rio Preto, São Paulo, 15090

  • Local Institution

    São Paulo, São Paulo, 01323

  • Local Institution

    São Paulo, São Paulo, 04005

  • Local Institution

    São Paulo, São Paulo, 04025

  • Local Institution

    São Paulo, São Paulo, 05403

Other trials in Brazil

France18 sites

  • Local Institution

    Angers, 49000

  • Local Institution

    Arras, 62022

  • Local Institution

    Besançon, 25000

  • Local Institution

    Clamart, 92141

  • Local Institution

    Clermont-Ferrand, 63003

  • Local Institution

    Dijon, 21079

  • Local Institution

    Grenoble, 38043

  • Local Institution

    Langres, 52206

  • Local Institution

    Le Kremlin-Bicêtre, 94275

  • Local Institution

    Lille, 59020

  • Local Institution

    Limoges, 87042

  • Local Institution

    Nantes, 44093

  • Local Institution

    Paris, 75004

  • Local Institution

    Paris, 75010

  • Local Institution

    Pierre-Bénite, 69495

  • Local Institution

    Saint-Priest-en-Jarez, 42270

  • Local Institution

    Toulouse, 31059

  • Local Institution

    Vernon, 27200

Other trials in France

Canada17 sites

  • Local Institution

    Edmonton, Alberta, T5H 4B9

  • Local Institution

    Edmonton, Alberta, T6G 2B7

  • Local Institution

    Greenfield Park, Quebec, J4V 2H1

  • Local Institution

    Hamilton, Ontario, L8L 2X2

  • Local Institution

    Hamilton, Ontario, L8N 4A6

  • Local Institution

    Hamilton, Ontario, L8S 4K1

  • Local Institution

    Montreal, Quebec, H1T 2M4

  • Local Institution

    Ottawa, Ontario, K1Y 4E9

  • Local Institution

    Saint John, New Brunswick, E2L 4L2

  • Local Institution

    Saint-Jérôme, Quebec, J7Z 5T3

  • Local Institution

    Toronto, Ontario, M5G 2C4

  • Local Institution

    Vancouver, British Columbia, V5Z 1M9

  • Local Institution

    Vancouver, British Columbia, V6Z 1Y6

  • Local Institution

    Victoria, British Columbia, V8R 6R5

  • Local Institution

    Waterloo, Ontario, N2J 1C4

  • Local Institution

    Windsor, Ontario, N8X 5A6

  • Local Institution

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

Germany17 sites

  • Local Institution

    Berlin, 10117

  • Local Institution

    Berlin, 10787

  • Local Institution

    Berlin, 12559

  • Local Institution

    Berlin, 14050

  • Local Institution

    Bochum, 44791

  • Local Institution

    Cologne, 50937

  • Local Institution

    Dortmund, 44137

  • Local Institution

    Dresden, 01067

  • Local Institution

    Dresden, 01307

  • Local Institution

    Frankfurt, 60596

  • Local Institution

    Göttingen, 37075

  • Local Institution

    Karlsbad, 76307

  • Local Institution

    Ludwigshafen, 67063

  • Local Institution

    Mannheim, 68161

  • Local Institution

    Mannheim, 68163

  • Local Institution

    München, 80331

  • Local Institution

    Munich, 80336

Other trials in Germany

China16 sites

  • Local Institution

    Beijing, Beijing Municipality, 100020

  • Local Institution

    Beijing, Beijing Municipality, 100029

  • Local Institution

    Beijing, Beijing Municipality, 100032

  • Local Institution

    Beijing, Beijing Municipality, 100035

  • Local Institution

    Beijing, Beijing Municipality, 100037

  • Local Institution

    Beijing, Beijing Municipality, 100038

  • Local Institution

    Beijing, Beijing Municipality, 100053

  • Local Institution

    Beijing, Beijing Municipality, 100191

  • Local Institution

    Guangzhou, Guangdong, 510080

  • Local Institution

    Hangzhou, Zhejiang, 130016

  • Local Institution

    Hangzhou, Zhejiang, 310016

  • Local Institution

    Shanghai, Shanghai Municipality, 200032

  • Local Institution

    Shanghai, Shanghai Municipality, 200127

  • Local Institution

    Shengyang, Liaoning, 110004

  • Local Institution

    Wuhan, Hubei, 430022

  • Local Institution

    Xi'an, 710032

Other trials in China

Israel16 sites

  • Local Institution

    Afula, 18101

  • Local Institution

    Ashkelon, 78278

  • Local Institution

    Hadera, 38101

  • Local Institution

    Haifa, 31048

  • Local Institution

    Haifa, 31096

  • Local Institution

    Holon, 58100

  • Local Institution

    Jerusalem, 91031

  • Local Institution

    Jerusalem, 91120

  • Local Institution

    Kfar Saba, 44281

  • Local Institution

    Nahariya, 22100

  • Local Institution

    Petah Tikva, 49100

  • Local Institution

    Rehovot, 76100

  • Local Institution

    Safed, 13100

  • Local Institution

    Tel Aviv, 64239

  • Local Institution

    Tel HaShomer, 52621

  • Local Institution

    Tiberias, Lower Galillee, 15208

Other trials in Israel

Italy16 sites

  • Local Institution

    Bologna, 40138

  • Local Institution

    Castelfranco Veneto (Tv), 31033

  • Local Institution

    Chieti Scalo, 66013

  • Local Institution

    Cosenza, 87100

  • Local Institution

    Milan, 20132

  • Local Institution

    Padova, 35128

  • Local Institution

    Palermo, 90127

  • Local Institution

    Pavia, 27100

  • Local Institution

    Piacenza, 29100

  • Local Institution

    Pisa, 56124

  • Local Institution

    Reggio Emilia, 42100

  • Local Institution

    Rome, 00168

  • Local Institution

    Rozzano (Mi), 20089

  • Local Institution

    San Daniele Del Friuli (Ud), 33038

  • Local Institution

    Vicenza, 36100

  • Local Institution

    Vittorio Veneto (Tv), 31029

Other trials in Italy

Poland16 sites

  • Local Institution

    Bialystok, 15-276

  • Local Institution

    Bydgoszcz, 85-168

  • Local Institution

    Bydgoszcz, 85-681

  • Local Institution

    Gdansk, 80-803

  • Local Institution

    Gdynia, 81-348

  • Local Institution

    Lodz, 90-153

  • Local Institution

    Lublin, 20-081

  • Local Institution

    Lublin, 20-718

  • Local Institution

    Poznan, 61-848

  • Local Institution

    Przeworsk, 37-200

  • Local Institution

    Szczecin, 70-111

  • Local Institution

    Warsaw, 01-138

  • Local Institution

    Warsaw, 02-005

  • Local Institution

    Warsaw, 02-776

  • Local Institution

    Wroclaw, 50-981

  • Local Institution

    Wroclaw, 51-124

Other trials in Poland

Australia14 sites

  • Local Institution

    Adelaide, South Australia, 5000

  • Local Institution

    Bedford Park, South Australia, 5042

  • Local Institution

    Box Hill, Victoria, 3128

  • Local Institution

    Clayton, Victoria, 3168

  • Local Institution

    Concord, New South Wales, 2139

  • Local Institution

    Garran, Australian Capital Territory, 2605

  • Local Institution

    Herston, Queensland, 4029

  • Local Institution

    Hobart, Tasmania, 7000

  • Local Institution

    Kogarah, New South Wales, 2217

  • Local Institution

    Lismore, New South Wales, 2480

  • Local Institution

    Perth, Western Australia, 6001

  • Local Institution

    Randwick, New South Wales, 2031

  • Local Institution

    Ringwood East, Victoria, 3135

  • Local Institution

    Windsor, Victoria, 3181

Other trials in Australia

India14 sites

  • Local Institution

    Ahmedabad, Gujarat, 380006

  • Local Institution

    Bangalore, Karnataka, 560054

  • Local Institution

    Bangalore, 560052

  • Local Institution

    Bangalore, 560099

  • Local Institution

    Bengaluru, Karnataka, 560017

  • Local Institution

    Chennai, Tamil Nadu, 600 006

  • Local Institution

    Gurgaon, Haryana, 122001

  • Local Institution

    Hyderabad, Andhra Pradesh, 500 082

  • Local Institution

    Hyderabad, Andhra Pradesh, 500034

  • Local Institution

    Ludhiana, Tagore Nagar, 141001

  • Local Institution

    Manipal, Karnataka, 576104

  • Local Institution

    Mohali, Punjab, 160062

  • Local Institution

    Pune, Maharashtra, 411001

  • Local Institution

    Pune, 411001

Other trials in India

Czechia12 sites

  • Local Institution

    Hradec Králové, 500 05

  • Local Institution

    Kladno, 272 59

  • Local Institution

    Litomyšl, 570 14

  • Local Institution

    Městec Králové, 289 03

  • Local Institution

    Ostrava, 708 52

  • Local Institution

    Ostrava Vitkovice, 703 84

  • Local Institution

    Prague, 100 34

  • Local Institution

    Prague, 110 00

  • Local Institution

    Prague, 118 33

  • Local Institution

    Prague, 128 08

  • Local Institution

    Ústí nad Labem, 401 13

  • Local Institution

    Ústí nad Orlicí, 562 18

Other trials in Czechia

Ukraine12 sites

  • Local Institution

    Chernihiv, 14034

  • Local Institution

    Dnipropetrovsk, 49000

  • Local Institution

    Donetsk, 83045

  • Local Institution

    Ivano-Frankivsk, 76008

  • Local Institution

    Ivano-Frankivsk, 76018

  • Local Institution

    Kharkiv, 61018

  • Local Institution

    Kyiv, 03680

  • Local Institution

    Lviv, 79010

  • Local Institution

    Odesa, 65117

  • Local Institution

    Ternopil, 46000

  • Local Institution

    Vinnytsia, 21018

  • Local Institution

    Zaporizhzhya, 69035

Other trials in Ukraine

Mexico10 sites

  • Local Institution

    Aguascalientes, Aguascalientes, 20230

  • Local Institution

    Durango, Durango, 34080

  • Local Institution

    Guadalajara, Jalisco, 44280

  • Local Institution

    León, Guanajuato, 37320

  • Local Institution

    Monterrey, Nuevo León, 64000

  • Local Institution

    Monterrey, Nuevo León, 64718

  • Local Institution

    Tijuana, Estado de Baja California, 22500

  • Local Institution

    Xalapa, Veracruz, 91020

  • Local Institution

    Zapopan, Jalisco, 45170

  • Local Institution

    Zapopan, Jalisco, 45200

Other trials in Mexico

Norway10 sites

  • Local Institution

    Ålesund, 6017

  • Local Institution

    Fredrikstad, 1606

  • Local Institution

    Gjettum, 1346

  • Local Institution

    Gjøvik, 2819

  • Local Institution

    Hamar, 2318

  • Local Institution

    Oslo, 0319

  • Local Institution

    Oslo, 0407

  • Local Institution

    Oslo, 0456

  • Local Institution

    Trondheim, 7006

  • Local Institution

    Tynset, 2500

Other trials in Norway

South Africa10 sites

  • Local Institution

    Bellville, Western Cape, 7530

  • Local Institution

    Bioemfontein, Free State, 9301

  • Local Institution

    Centurion, Gauteng, 0157

  • Local Institution

    Durban, KwaZulu-Natal, 4001

  • Local Institution

    George, Western Cape, 6529

  • Local Institution

    Parktown, Gauteng, 2193

  • Local Institution

    Pietermaritzburg, KwaZulu-Natal, 3201

  • Local Institution

    Pretoria, Gauteng, 0084

  • Local Institution

    Somerset West, Western Cape, 7130

  • Local Institution

    Worcester, Western Cape, 6850

Other trials in South Africa

Spain10 sites

  • Local Institution

    Getafe, 28905

  • Local Institution

    L'Hospitalet de Llobregat, 08907

  • Local Institution

    León, 24008

  • Local Institution

    Madrid, 28007

  • Local Institution

    Madrid, 28029

  • Local Institution

    Madrid, 28041

  • Local Institution

    Málaga, 29010

  • Local Institution

    Mourente, 36071

  • Local Institution

    Tarragona, 43007

  • Local Institution

    Torrevieja, Alicante, 03186

Other trials in Spain

Hungary9 sites

  • Local Institution

    Budapest, 1032

  • Local Institution

    Budapest, 1097

  • Local Institution

    Budapest, 1125

  • Local Institution

    Gyula, 5700

  • Local Institution

    Kecskemét, 6000

  • Local Institution

    Miskolc, 3501

  • Local Institution

    Mosonmagyaróvár, 9200

  • Local Institution

    Székesfehérvár, 8000

  • Local Institution

    Zalaegerszeg, 8900

Other trials in Hungary

Argentina7 sites

  • Local Institution

    Buenos Aires, Buenos Aires, C1280AEB

  • Local Institution

    Ciudad Autonoma de Buenos Aire, Buenos Aires, C1180AAX

  • Local Institution

    Córdoba, Córdoba Province, 5000

  • Local Institution

    Corrientes, Corrientes Province, 3400

  • Local Institution

    Rosario, Santa Fe Province, 2000

  • Local Institution

    Rosario, Santa Fe Province, S2000CVB

  • Local Institution

    Rosario, Santa Fe Province, S2000DSV

Other trials in Argentina

Denmark7 sites

  • Local Institution

    Arhus C, 8000

  • Local Institution

    Hellerup, 2900

  • Local Institution

    Herning, 7400

  • Local Institution

    Hilleroed, 3400

  • Local Institution

    Horsens, 8700

  • Local Institution

    Næstved, 4700

  • Local Institution

    Silkeborg, 8600

Other trials in Denmark

Austria6 sites

  • Local Institution

    Graz, 8036

  • Local Institution

    Innsbruck, 6020

  • Local Institution

    Vienna, 1090

  • Local Institution

    Vienna, 1100

  • Local Institution

    Vienna, 1140

  • Local Institution

    Vienna, 1160

Other trials in Austria

Chile5 sites

  • Local Institution

    Independencia, Santiago Metropolitan, XXXXX

  • Local Institution

    Punta Arenas, Magallanes Antartica, 6212296

  • Local Institution

    Santiago, Santiago Metropolitan, 7600448

  • Local Institution

    Santiago, Santiago Metropolitan, 8330024

  • Local Institution

    Viña del Mar, Valparaiso, 2520000

Other trials in Chile

Romania5 sites

  • Local Institution

    Baia Mare, 430031

  • Local Institution

    Bucharest, 022328

  • Local Institution

    Bucharest, 030171

  • Local Institution

    Bucharest, 050098

  • Local Institution

    Târgu Mureş, 540136

Other trials in Romania

Malaysia4 sites

  • Local Institution

    George Town, Pulau Pinang, 10350

  • Local Institution

    Ipoh, Perak, 30990

  • Local Institution

    Kuala Lumpur, Kuala Lumpur, 50586

  • Local Institution

    Malacca, Melaka, 75400

Other trials in Malaysia

Portugal4 sites

  • Local Institution

    Coimbra, 3004-548

  • Local Institution

    Guarda, 6301-857

  • Local Institution

    Lisbon, 1169-050

  • Local Institution

    Lisbon, 1769-001

Other trials in Portugal

South Korea4 sites

  • Local Institution

    Busan, 602-702

  • Local Institution

    Seoul, 120752

  • Local Institution

    Seoul, 137-040

  • Local Institution

    Seoul, 138736

Other trials in South Korea

Singapore3 sites

  • Local Institution

    Singapore, 169608

  • Local Institution

    Singapore, 308433

  • Local Institution

    Singapore, 529889

Other trials in Singapore

Hong Kong2 sites

  • Local Institution

    Pokfulman, XXXXX

  • Local Institution

    Shatin, N.T

Other trials in Hong Kong

Puerto Rico1 site

  • Local Institution

    San Juan, 00921

Other trials in Puerto Rico

United Kingdom1 site

  • Local Institution

    Livingston, West Lothian, EH54 7BH

Other trials in United Kingdom

About this study

Official title: A Safety and Efficacy Trial Evaluating the Use of Apixaban in the Treatment of Symptomatic Deep Vein Thrombosis and Pulmonary Embolism

The purpose of this study is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients with deep vein thrombosis (DVT) or pulmonary embolism (PE)

Being tested
Enoxaparin, warfarin, Placebo for apixaban, Placebo for enoxaparin, Placebo for warfarin
Medical subject headings
Venous Thrombosis

What participants receive

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

  • EnoxaparinDrug

    solution, subcutaneous, 1 mg/kg Q12h until International normalized ratio (INR) ≥2.

  • warfarinDrug

    Also called Coumadin, BMS-565793

    tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months

  • Placebo for apixabanDrug

    tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months

  • Placebo for enoxaparinDrug

    solution, subcutaneous, 1 mg/kg Q12h until sham INR ≥2.

  • Placebo for warfarinDrug

    tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months

  • apixabanDrug

    Also called BMS-562247

    tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months

Study groups in NCT00643201
Study groupRoleWhat they receive
ApixabanActive comparatorapixaban: tablets, oral, 10 milligram (mg) tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months.
Receives: Drug: Enoxaparin; Drug: warfarin; Drug: Placebo for apixaban
Enoxaparin + WarfarinExperimentalEnoxaparin: solution, subcutaneous, 1 mg/kg Q12h until international normalized ratio (INR) ≥2.
Receives: Drug: Placebo for enoxaparin; Drug: Placebo for warfarin; Drug: apixaban

What is being measured

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

  1. Incidence of Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or VTE-Related Death During 6 Months of Treatment

    VTE: nonfatal deep vein thrombosis (DVT) or nonfatal pulmonary embolism (PE). All events were adjudicated by an ICAC blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants): n/N (n=number of participants with observation; N=total number of efficacy evaluable participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint: events at any time from randomization until end of intended treatment, regardless whether drug treatment was received. All randomized participants with a non-missing primary endpoint were summarized. Missing endpoint = outcomes which could not be documented on or after study Day 154. Participants were categorized to the assigned group regardless of the treatment actually received (intent-to-treat).

    Measured: Day 1 to Week 24 + 2 Days or 355 days (Discontinued Early)

Secondary outcomes (20)

  1. Incidence of Adjudicated Composite of Recurrent Symptomatic Venous Thromboembolism (VTE) or All-Cause Death

    VTE included: nonfatal DVT or nonfatal PE. All events were adjudicated by an ICAC blinded to treatment. DVT was assessed by compression ultrasound and/or venography; PE was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of participants with observation; N=total number of efficacy evaluable participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received, ie intent to treat (ITT) principle. Each participant scored as having an event only if they experienced one or more of the elements of the composite. Participants with missing endpoint information excluded.

    Measured: Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)

  2. Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or Cardiovascular (CV)-Related Death

    VTE included: nonfatal DVT or nonfatal PE. All events were adjudicated by an ICAC blinded to treatment. DVT was assessed by compression ultrasound and/or venography; PE was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of participants with observation; N=total number of efficacy evaluable participants, participants with missing endpoint information excluded). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received, ie, ITT principle. Each participant scored as having an event only if the participant experienced one or more of the elements of the composite.

    Measured: Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)

  3. Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or VTE-related Death or Major Bleeding

    VTE included: nonfatal DVT or nonfatal PE. All events were adjudicated by an ICAC blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Major bleeding defined by International Society on Thrombosis and Haemostasis: acute, clinically overt bleeding associated with decrease in hemoglobin (Hgb) of 2 g/dL or more or bleeding leading to transfusion or bleeding in a critical site or bleeding that is fatal . Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint and including those not in the efficacy evaluable population with a bleeding event that occurred during treatment period. Events included regardless of whether or not participant received treatment, ie, ITT principle

    Measured: Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)

  4. Incidence of Adjudicated Composite of Recurrent Symptomatic VTE, Myocardial Infarction, Stroke, CV-related Death, Clinically Relevant Non-major (CRNM) Bleeding or Major Bleeding

    VTE=Nonfatal DVT or nonfatal PE adjudicated by ICAC blinded to treatment. DVT: compression ultrasound and/or venography; PE: spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Major Bleeding = acute, clinically overt bleeding: decrease in Hgb of 2 g/dL or more or bleeding leading to transfusion or bleeding in a critical site or fatal bleeding. CRNM = acute clinically overt bleeding: compromising hemodynamics, leading to hospitalization, hematoma, epistasis >5 minutes or repetitive, gingival bleeding, hematuria, macroscopic gastrointestinal hemorrhage, rectal blood loss, hemoptysis. n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint and including those not in the efficacy evaluable population with a bleeding event that occurred during treatment period). Events included regardless of whether or not treatment was received (ITT).

    Measured: Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)

  5. Incidence of Adjudicated Symptomatic Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period

    DVT adjudicated by an ICAC blinded to treatment. DVT evaluated by: compression ultrasound and/or venography. Includes events that occurred during the intended treatment period, regardless of whether the participant received study medication, intent to treat principle (ITT). Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early).

    Measured: Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)

  6. Incidence of Adjudicated Symptomatic Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period

    PE adjudicated by an ICAC blinded to treatment. PE: spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Includes events that occurred during the intended treatment period, regardless of whether the participant received study medication (ITT principle). Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early).

    Measured: Day 1 to Week 24 + + 2 Days or 355 Days (Discontinued Early)

  7. Incidence of Adjudicated Venous Thromboembolism (VTE)-Related Death During the Intended Treatment Period

    VTE-related death included: DVT-related death or PE-related death. All events were adjudicated by an ICAC blinded to treatment. DVT was assessed by compression ultrasound and/or venography; PE was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of participants with observation; N=total number of participants in respective treatment groups excluding participants with missing endpoint information). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Includes events that occur during the intended treatment period regardless of whether or not the participant received study medication (ITT principle).

    Measured: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)

  8. Incidence of Cardiovascular (CV)-Related Death Including VTE-related Death During the Intended Treatment Period

    VTE-related death included: DVT-related death or PE-related death. All events were adjudicated by an ICAC blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of participants with observation; N=total number of participants in respective treatment groups excluding participants with missing endpoint information). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Includes events that occur during the intended treatment period regardless of whether or not the participant received study medication (ITT principle).

    Measured: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)

  9. Incidence of All-Cause Death During the Intended Treatment Period

    Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Includes events that occurred during the intended treatment period, regardless of whether the participant received study medication (ITT principle). Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint information).

    Measured: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)

  10. Incidence of Adjudicated Major Bleeding During the Treatment Period in Treated Participants

    All events were adjudicated by an ICAC blinded to treatment. Bleeding defined by International Society on Thrombosis and Haemostasis: Major Bleeding: acute, clinically overt bleeding: decrease in hemoglobin (hgb) of 2 g/dL or more or bleeding leading to transfusion or bleeding in a critical site or fatal bleeding. Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants in respective treatment group (all participants who received at least one dose of study drug). Participants were categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to the treatment received.

    Measured: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)

  11. Incidence of Adjudicated Major/CRNM Bleeding During the Treatment Period in Treated Participants

    Major Bleeding = acute, clinically overt bleeding: decrease in hemoglobin of 2 g/dL or more, or bleeding leading to transfusion, or bleeding in a critical site, or fatal bleeding. CRNM = acute clinically overt bleeding: compromising hemodynamics, leading to hospitalization, hematoma, epistasis >5 minutes or repetitive, gingival bleeding, hematuria, macroscopic gastrointestinal hemorrhage, rectal blood loss, hemoptysis. Minor =: All acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRNM. All events were adjudicated by an ICAC blinded to treatment. Total bleeding = any of major, or CRNM, or minor bleeding. Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of treated (received at least 1 dose of study drug).

    Measured: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)

  12. Incidence of Adjudicated Clinically Relevant Non Major (CRNM) Bleeding During the Treatment Period in Treated Participants

    Bleeding defined by International Society on Thrombosis and Haemostasis: CRNM defined as acute clinically overt bleeding: compromising hemodynamics, leading to hospitalization, hematoma, epistasis >5 minutes or repetitive, gingival bleeding, hematuria, macroscopic gastrointestinal hemorrhage, rectal blood loss, hemoptysis. All events were adjudicated by an ICAC blinded to treatment. Event rate (proportion of participants with event): calculated as n/N (n=number of participants with observation; N=Total number of participants in respective treatment group (all participants who received at least one dose of study drug). Participants were categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to the treatment received.

    Measured: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)

  13. Incidence of Adjudicated Minor Bleeding During the Treatment Period in Treated Participants

    Bleeding defined by International Society on Thrombosis and Haemostasis: Minor bleeding: all acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRNM. All events wre adjudicated by an ICAC blinded to treatment. Event rate (proportion of participants) calculated as n/N (n=number of participants with observation; N=Total number of participants in respective treatment group (all participants who received at least one dose of study drug). Participants were categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to the treatment received.

    Measured: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)

  14. Incidence of Adjudicated Total Bleeding During the Treatment Period in Treated Participants

    Bleeding defined by International Society on Thrombosis and Haemostasis: Total Bleeding defined as any of major, CRNM, or minor bleeding. All events were adjudicated by an ICAC blinded to treatment. Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants in respective treatment group (all participants who received at least one dose of study drug). Participants were categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to the treatment received.

    Measured: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)

  15. Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Bleeding AEs, Discontinuations Due to AEs and Death During the Treatment Period in Treated Participants

    Treated Participants: all who received at least 1 dose of study drug. Participants categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to treatment received. Included all SAEs and AEs with onset from first dose to last dose + 2 days (for AEs) or + 30 days (for SAEs); note; bleeding AEs and SAEs from first dose to last dose + 2 days included. Discontinuations due to AE included all AEs/SAEs from first dose until drug was discontinued. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.

    Measured: First dose to last dose of 24 Weeks + 2 days (AEs) or + 30 days (SAEs) or until drug discontinued

  16. Number of Treated Participants With Marked Abnormalities in Hematology Laboratory Tests

    Lower limit of normal (LLN). Upper limit of normal (ULN). Pre-therapy (PreRx). Absolute (Abs) neutrophil count, bands + neutrophils (ANC). Cells per microliter (c/µL). Grams per deciliter (g/dL). Cells per Liter (c/L). Millimeter (MM). White blood cells: < 0.75*LLN, > 1.25*ULN; Hemoglobin: <= 11.5 g/dL (males), <= 9.5 g/dL (females); Hematocrit: <= 37% (males), <= 32% (females); Erythrocytes: <0.75*10^6 c/µL*PreRx; Platelet count: < 75*10^9 c/L, > 700*10^9 c/L; ANC: < 1.00*10^3 c/µL; Abs eosinophils: > 0.750*10^3 c/µL; Abs Basophils: > 400/MM^3; Abs Monocytes> 2000/MM^3; Abs Lymphocytes: < 0.750*10*3 c/ µL, > 7.5*10^3 c/ µL.

    Measured: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)

  17. Number of Treated Participants With Marked Abnormalities in Electrolyte Laboratory Tests

    Bicarbonate milliequivalents/Liter (mEq/L) Low/High: < 0.75*LLN or > 1.25*ULN, or if pre-dose < LLN then use < 0.75*pre-dose or > ULN if pre-dose > ULN then use > 1.25*pre-dose or < LLN; Serum Calcium mg/dL Low/High: < 0.8*LLN or > 1.2*ULN, or if pre-dose < LLN then use < 0.75*pre-dose or > ULN if pre-dose > ULN then use > 1.25*pre-dose or < LLN; Serum Chloride mEq/L: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use < 0.9*pre-dose or > ULN if pre-dose > ULN then use > 1.1*pre-dose or < LLN; Serum Potassium mEq/L: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use < 0.9*pre-dose or > ULN if pre-dose > ULN then use > 1.1*pre-dose or < LLN; Serum Sodium mEq/L: < 0.95*LLN or > 1.05*ULN, or if pre-dose < LLN then use < 0.95*pre-dose or > ULN if pre-dose > ULN then use > 1.05*pre-dose or < LLN.

    Measured: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)

  18. Number of Treated Participants With Marked Abnormalities in Kidney and Liver Function Laboratory Tests

    Blood urea nitrogen (BUN), milligrams/deciliter (mg/dL), units per liter (U/L). BUN mg/dL High: > 1.5*ULN; Creatinine mg/dL: > 1.5*ULN; Alanine aminotransferase (ALT) U/L: > 3*ULN; Aspartate aminotransferase (AST) U/L: > 3*ULN; Alkaline phosphatase U/L: > 2*ULN; Bilirubin Direct mg/dL: > 1.5*ULN; Bilirubin Total mg/dL: > 2*ULN.

    Measured: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)

  19. Number of Treated Participants With Marked Abnormalities in Creatine Kinase, Uric Acid, and Total Protein Laboratory Tests

    Creatine kinase High: >5*ULN Units/Liter (U/L); Total Protein High/Low: < 0.9 *LLN or > 1.1*ULN, or if pre-dose < LLN then use 0.9* pre-dose or > ULN if pre-dose > ULN then use 1.1 *pre-dose or <LLN; Uric acid High: > 1.5* ULN, or if pre-dose > ULN then use > 2 *pre-dose.

    Measured: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)

  20. Number of Treated Participants With Marked Abnormalities in Urinalysis Laboratory Tests

    All tests in urine: Glucose: If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4; Protein: If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4; Blood: If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4; Leukocyte esterase: If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4;Red blood cells (RBC): If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4; White blood cells (WBC): If missing pre-dose use ≥ 2, or if value ≥ 4, or if pre-dose = 0 or 0.5 use ≥ 2, or if pre-dose = 1 use ≥ 3, or if pre-dose = 2 or 3 use ≥ 4.

    Measured: Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)

Timeline

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

  1. First posted26 Mar 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionMar 2013
  4. Study completionMar 2013

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
5,614 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00643201
Sponsor's protocol ID
CV185-056
Other IDs
EUDRACT: 2007-007867-25
Status last verified
Apr 2014
First submitted
20 Mar 2008
Last updated
21 Apr 2014
Data monitoring committee
Yes

Publications

  • Jamieson MJ, Byon W, Dettloff RW, Crawford M, Gargalovic PS, Merali SJ, Onorato J, Quintero AJ, Russ C. Apixaban Use in Obese Patients: A Review of the Pharmacokinetic, Interventional, and Observational Study Data. Am J Cardiovasc Drugs. 2022 Nov;22(6):615-631. doi: 10.1007/s40256-022-00524-x. Epub 2022 May 16.

    PubMed 35570249

  • Cohen AT, Pan S, Byon W, Ilyas BS, Taylor T, Lee TC. Efficacy, Safety, and Exposure of Apixaban in Patients with High Body Weight or Obesity and Venous Thromboembolism: Insights from AMPLIFY. Adv Ther. 2021 Jun;38(6):3003-3018. doi: 10.1007/s12325-021-01716-8. Epub 2021 Apr 22.

    PubMed 33890242

  • Cohen AT, Agnelli G, Buller HR, Gallus A, Raskob GE, Sanders P, Thompson J, Weitz JI. Characteristics and Outcomes in Patients with Venous Thromboembolism Taking Concomitant Anti-Platelet Agents and Anticoagulants in the AMPLIFY Trial. Thromb Haemost. 2019 Mar;119(3):461-466. doi: 10.1055/s-0038-1676983. Epub 2019 Jan 16.

    PubMed 30650446

  • Liu X, Johnson M, Mardekian J, Phatak H, Thompson J, Cohen AT. Apixaban Reduces Hospitalizations in Patients With Venous Thromboembolism: An Analysis of the Apixaban for the Initial Management of Pulmonary Embolism and Deep-Vein Thrombosis as First-Line Therapy (AMPLIFY) Trial. J Am Heart Assoc. 2015 Dec 1;4(12):e002340. doi: 10.1161/JAHA.115.002340.

    PubMed 26627879

  • Agnelli G, Buller HR, Cohen A, Curto M, Gallus AS, Johnson M, Masiukiewicz U, Pak R, Thompson J, Raskob GE, Weitz JI; AMPLIFY Investigators. Oral apixaban for the treatment of acute venous thromboembolism. N Engl J Med. 2013 Aug 29;369(9):799-808. doi: 10.1056/NEJMoa1302507. Epub 2013 Jul 1.

    PubMed 23808982

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Enoxaparin and warfarin in people with Venous Thrombosis, run by Bristol-Myers Squibb at 381 sites in 31 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 2 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 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 381 sites in United States, Russia, Brazil, France, Canada and 26 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 10 Apr 2014). 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?

Incidence of Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or VTE-Related Death During 6 Months of Treatment (time frame: Day 1 to Week 24 + 2 Days or 355 days (Discontinued Early)). 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 NCT00643201, which also lists 5 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 21 Apr 2014.

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