AzTrials
AzTrials

Venous ThrombosisPhase 3NCT00633893

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

A Phase 3 study testing Apixaban in people with Venous Thrombosis, run by Bristol-Myers Squibb at 428 sites in 29 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

The purpose is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients who have completed their intended treatment for 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?
Apixaban
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,711 participants
Where
428 sitesin 29 countries
Study dates
May 2008to Aug 2012
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 Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE);
  • Anticoagulant treatment completed
  • No recurrence of Venous Thromboembolism (VTE)

Who cannot join

  • Subjects with indications for long-term treatment with a vitamin K antagonist
  • Active bleeding or high risk for serious bleeding
  • Short life expectancy
  • Uncontrolled high blood pressure
  • Impaired kidney or liver function

Trial locations and contacts

428 sites in 29 countries.

428 sites in 29 countries

United States87 sites

  • Akron General Medical Center

    Akron, Ohio, 44307

  • Amarillo Heart Clinical Research Institute Inc.

    Amarillo, Texas, 79106

  • Anne Arundel Health System Research Institute, Inc.

    Annapolis, Maryland, 21401

  • Rocky Mountain Internal Medicine

    Aurora, Colorado, 80012

  • Vascular Surgical Associates, Pc

    Austell, Georgia, 30106

  • 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

  • Boise Orthopedic Clinic

    Boise, Idaho, 83706

  • Holston Medical Group

    Bristol, Tennessee, 37620

  • Kaleida Health System

    Buffalo, New York, 14209

  • Mercury Street Medical Group, Pllc

    Butte, Montana, 59701

  • Community Health Care, Inc.

    Canal Fulton, Ohio, 44614

  • Infectious Disease Of Indiana Psc

    Carmel, Indiana, 46032

  • Valley Medical Research

    Centerville, Ohio, 45459

  • Charleston Hematology Oncology Associates, Pa

    Charleston, South Carolina, 29414

  • University Of Virginia Health System

    Charlottesville, Virginia, 22908

  • Research Alliance, Inc.

    Clearwater, Florida, 33756

  • St. Francis Sleep Allergy & Lung Institute

    Clearwater, Florida, 33765

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Remington Davis Inc.

    Columbus, Ohio, 43215

  • Corsicana Medical Research

    Corsicana, Texas, 75110

  • Atlanta Institute For Medical Research, Inc

    Decatur, Georgia, 30030

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Thomas L. Ortel, Md, Phd

    Durham, North Carolina, 27710

  • Valley Internal Medicine

    Fayetteville, North Carolina, 28304

  • Berma Research Group

    Fort Lauderdale, Florida, 33316

  • Fort Smith Lung Center

    Fort Smith, Arkansas, 72901

  • New West Physicians

    Golden, Colorado, 80401

  • Goshen Medical Associates

    Goshen, New York, 10924

  • 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

  • Healthworx

    Hollywood, Florida, 33021

  • Ankur Doshi, Md

    Houston, Texas, 77024

  • Cape Cod Research Institute

    Hyannis, Massachusetts, 02601

  • Three Rivers Medical Associates, Pa

    Irmo, South Carolina, 29063

  • Veterans Affairs Medical Center

    Kansas City, Missouri, 64128

  • Holston Medical Group

    Kingsport, Tennessee, 37660

  • Scripps Clinic/Scripps Health And Green Hospital

    La Jolla, California, 92037

  • Gwinnett Biomedical Research

    Lawrenceville, Georgia, 30046

  • Tanner Clinic

    Layton, Utah, 84041

  • Sjh Cardiology Associates

    Liverpool, New York, 13088

  • Healthcare Partners Medical Group

    Los Angeles, California, 90015

  • Hematology Oncology Associates

    Loxahatchee Groves, Florida, 33470

  • Medical Assoicates Inc.

    Menomonee Falls, Wisconsin, 53051

  • South Miami Heart Center

    Miami, Florida, 33143

  • Mission Internal Medical Group

    Mission Viejo, California, 92691

  • Clinical Research Authority, Llc

    Murrells Inlet, South Carolina, 29576

  • Saltzer Medical Group

    Nampa, Idaho, 83686

  • Physicians Regional Medical Group

    Naples, Florida, 34119

  • Office Of:Eugene C. Fletcher, Md

    New Albany, Indiana, 47150

  • Alfieri Cardiology

    Newark, Delaware, 19713

  • Sentara York Clinical Research

    Norfolk, Virginia, 23510

  • Cor Clinical Research, Llc

    Oklahoma City, Oklahoma, 73103

  • Creighton University Medical Center

    Omaha, Nebraska, 68131

  • Owensboro Heart & Vascular

    Owensboro, Kentucky, 42303

  • Desert Med Grp Inc, Dba Desert Oasis Healthcare Med Group

    Palm Springs, California, 92262

  • Cardiovascular Consultants, Ltd.

    Phoenix, Arizona, 85032

  • Pma Medical Specialists

    Phoenixville, Pennsylvania, 19460

  • Richard A. Mclean M.D., P.A.

    Plantation, Florida, 33317

  • Indus Clinical Research Institute, Inc.

    Pomona, California, 91767

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Rex Healthcare

    Raleigh, North Carolina, 27607

  • Pen Bay Medical Center

    Rockport, Maine, 04856

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • University Of Utah Hospital

    Salt Lake City, Utah, 84132

  • Kaiser Permanente Medical Center

    San Francisco, California, 94118

  • 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

  • Robert J. Bloomberg, Md, Pc

    Tempe, Arizona, 85283

  • Jobst Vascular Center At The Toledo Hospital

    Toledo, Ohio, 43606

  • Northwest Heart Center

    Tomball, Texas, 77375

  • Harbor Ucla Medical Center

    Torrance, California, 90509

  • New York Medical College

    Valhalla, New York, 10595

  • Primary Care Of The Treasure Coast, Inc.

    Vero Beach, Florida, 32960

  • Progressive Clinical Research

    Vista, California, 92083

  • Cleveland Clinic Florida

    Weston, Florida, 33331

  • Whiteville Medical Associates, P.A.

    Whiteville, North Carolina, 28472

  • Wilmington Medical Research

    Wilmington, North Carolina, 28401

  • Heartland Vascular Medicine And Surgery

    Windsor Heights, Iowa, 50324

Other trials in United States

Brazil23 sites

  • Local Institution

    Belo Horizonte - Mg, Minas Gerais, 30130

  • Local Institution

    Belo Horizonte - Mg, Minas Gerais, 30150

  • Local Institution

    Botucatu, São Paulo, 18618

  • Local Institution

    Brasília, Federal District, 70335

  • Local Institution

    Campinas, São Paulo, 13083

  • Local Institution

    Curitiba, Paraná, 80030

  • Local Institution

    Curitiba, Paraná, 80050

  • Local Institution

    Curitiba, Paraná, 80810

  • Local Institution

    Curitiba, Paraná, 81520

  • 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, 90610

  • Local Institution

    Porto Alegre, Rio Grande do Sul, 9110270

  • Local Institution

    Rio de Janeiro, Rio de Janeiro, 20551

  • Local Institution

    Rio Janeiro, Rio de Janeiro, 22280

  • Local Institution

    Salvador, Estado de Bahia, 40144 900

  • Local Institution

    Santo Andre - Sp, São Paulo, 09060

  • Local Institution

    São José do Rio Preto, São Paulo, 15015

  • Local Institution

    São José do Rio Preto, São Paulo, 15090

  • Local Institution

    São Paulo, São Paulo, 01323

  • Local Institution

    São Paulo, São Paulo, 01509

  • Local Institution

    São Paulo, São Paulo, 04005

  • Local Institution

    São Paulo, São Paulo, 05403

Other trials in Brazil

Poland22 sites

  • Local Institution

    Arkonska 4, 71455

  • Local Institution

    Bialystok, 15-276

  • Local Institution

    Bydgoszcz, 85-168

  • Local Institution

    Bydgoszcz, 85-650

  • Local Institution

    Bydgoszcz, 85-681

  • Local Institution

    Gdansk, 80-803

  • Local Institution

    Gdynia, 81-348

  • Local Institution

    Gdynia, 81-423

  • 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

    Tarnobrzeg, 39-400

  • Local Institution

    Warsaw, 01-138

  • Local Institution

    Warsaw, 01-809

  • Local Institution

    Warsaw, 02-005

  • Local Institution

    Warsaw, 02-018

  • Local Institution

    Warsaw, 02-776

  • Local Institution

    Wroclaw, 51-124

  • Local Institution

    Wroclaw, 53-114

Other trials in Poland

Italy21 sites

  • Local Institution

    Bollate, 20021

  • Local Institution

    Bologna, 40138

  • Local Institution

    Chieti Scalo, 66013

  • Local Institution

    Cosenza, 87100

  • Local Institution

    Ferrara, 44100

  • Local Institution

    Florence, 50134

  • Local Institution

    Genova, 16128

  • Local Institution

    Milan, 20132

  • Local Institution

    Padova, 35128

  • Local Institution

    Palermo, 90127

  • Local Institution

    Pavia, 27100

  • Local Institution

    Perugia, 06132

  • Local Institution

    Piacenza, 29100

  • Local Institution

    Pisa, 56124

  • Local Institution

    Roma, 00168

  • Local Institution

    Rozzano (Mi), 20089

  • Local Institution

    San Daniele Del Friuli (Ud), 33038

  • Local Institution

    Udine, 33100

  • Local Institution

    Venezia, 30122

  • Local Institution

    Vicenza, 36100

  • Local Institution

    Vittorio Veneto (Tv), 31029

Other trials in Italy

Argentina20 sites

  • Local Institution

    Buenos Aires, Buenos Aires, C1122AAL

  • Local Institution

    Buenos Aires, Buenos Aires, C1280AEB

  • Local Institution

    Buenos Aires, Buenos Aires, C1431FWO

  • Local Institution

    Capital Federal, Buenos Aires, C1426ANZ

  • Local Institution

    Ciudad Autonoma de Buenos Aire, Buenos Aires, 1093 AAS

  • Local Institution

    Ciudad Autonoma de Buenos Aire, Buenos Aires, C1180AAX

  • Local Institution

    Ciudad Autonoma de Buenos Aire, Buenos Aires, C1437JCP

  • Local Institution

    Ciudad de Buenos Aires, Buenos Aires, C1034ACO

  • Local Institution

    Ciudad de Buenos Aires, Buenos Aires, C1181ACH

  • Local Institution

    Córdoba, Córdoba Province, 5000

  • Local Institution

    Córdoba, Córdoba Province, X5000JHQ

  • Local Institution

    Coronel Suárez, Buenos Aires, B7540GHD

  • Local Institution

    Corrientes, Corrientes Province, 3400

  • Local Institution

    La Plata, Buenos Aires, 1900

  • Local Institution

    La Plata, Buenos Aires, B1902COI

  • Local Institution

    Mar del Plata, Buenos Aires, 7600

  • Local Institution

    Rosario, Santa Fe Province, S2000CVB

  • Local Institution

    Rosario, Santa Fe Province, S2000DSV

  • Local Institution

    Rosario, Santa Fe Province, S2002KDS

  • Local Institution

    San Martín, Buenos Aires, B1650CSQ

Other trials in Argentina

Germany20 sites

  • Local Institution

    Berlin, 10117

  • Local Institution

    Berlin, 10787

  • Local Institution

    Berlin, 14050

  • Local Institution

    Bochum, 44791

  • Local Institution

    Bonn, 53115

  • Local Institution

    Cologne, 50937

  • Local Institution

    Dortmund, 44137

  • Local Institution

    Dresden, 01067

  • Local Institution

    Dresden, 01307

  • Local Institution

    Erfurt, 99089

  • Local Institution

    Frankfurt, 60596

  • Local Institution

    Göttingen, 37075

  • Local Institution

    Karlsbad, 76307

  • Local Institution

    Krefeld, 47805

  • Local Institution

    Ludwigshafen, 67063

  • Local Institution

    Mannheim, 68161

  • Local Institution

    Mannheim, 68165

  • Local Institution

    Mannheim, 68167

  • Local Institution

    München, 80331

  • Local Institution

    Munich, 80336

Other trials in Germany

Spain20 sites

  • Local Institution

    Badalona, Barcelona, 08916

  • Local Institution

    Cadiz, 11009

  • Local Institution

    Getafe, 28905

  • Local Institution

    Girona, 17007

  • Local Institution

    L'Hospitalet de Llobregat, 08907

  • Local Institution

    León, 24008

  • Local Institution

    Madrid, 28007

  • Local Institution

    Madrid, 28029

  • Local Institution

    Madrid, 28040

  • Local Institution

    Madrid, 28041

  • Local Institution

    Majadahonda, Madrid, 28222

  • Local Institution

    Mourente, 36071

  • Local Institution

    Pamplona, 31008

  • Local Institution

    Salamanca, 37007

  • Local Institution

    San Sebastián de los Reyes, Madrid, 28702

  • Local Institution

    Sant Boi de Llobregat, 08830

  • Local Institution

    Tarragona, 43007

  • Local Institution

    Toledo, 45071

  • Local Institution

    Torrevieja, Alicante, 03186

  • Local Institution

    Valencia, 46026

Other trials in Spain

Mexico19 sites

  • Local Institution

    Aguascalientes, Aguascalientes, 20230

  • Local Institution

    Chihuahua City, Chihuahua, 31203

  • Local Institution

    Culiacán, Sinaloa, 80020

  • Local Institution

    Culiacán, Sinaloa, 80230

  • Local Institution

    Durango, Durango, 34080

  • Local Institution

    Guadalajara, Jalisco, 44130

  • Local Institution

    Guadalajara, Jalisco, 44200

  • Local Institution

    Guadalajara, Jalisco, 44280

  • Local Institution

    León, Guanajuato, 37320

  • Local Institution

    Mexico City, Mexico City, 06726

  • Local Institution

    Monterrey, Nuevo León, 64000

  • Local Institution

    Monterrey, Nuevo León, 64710

  • Local Institution

    Puebla City, Puebla, 72000

  • Local Institution

    Querétaro City, Querétaro, 76000

  • Local Institution

    San Luis Potosí City, San Luis Potosí, 78200

  • Local Institution

    San Luis Potosí City, San Luis Potosí, 78240

  • Local Institution

    Tijuana, Estado de Baja California, 22500

  • Local Institution

    Xalapa, Veracruz, 91020

  • Local Institution

    Zapopan, Jalisco, 45200

Other trials in Mexico

Russia19 sites

  • Local Institution

    Arkhangelsk, 163045

  • Local Institution

    Kemerovo, 650002

  • Local Institution

    Moscow, 105077

  • Local Institution

    Moscow, 111539

  • Local Institution

    Moscow, 119049

  • Local Institution

    Moscow, 127473

  • Local Institution

    Novosibirsk, 630055

  • 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, 199106

  • Local Institution

    Samara, 443010

  • Local Institution

    Saratov, 410012

  • Local Institution

    Saratov, 410028

  • Local Institution

    Tomsk, 634012

  • Local Institution

    Yaroslavl, 150062

Other trials in Russia

Australia18 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

    Footscray, Victoria, 3011

  • Local Institution

    Garran, Australian Capital Territory, 2605

  • Local Institution

    Herston, Queensland, 4029

  • Local Institution

    Kippa-Ring, Queensland, 4021

  • Local Institution

    Kogarah, New South Wales, 2217

  • Local Institution

    Launceston, Tasmania, 7250

  • Local Institution

    Lismore, New South Wales, 2480

  • Local Institution

    Parkville, Victoria, 3050

  • Local Institution

    Perth, Western Australia, 6000

  • Local Institution

    Richmond, Victoria, 3121

  • Local Institution

    Ringwood East, Victoria, 3135

  • Local Institution

    St Leonards, New South Wales, 2065

  • Local Institution

    Windsor, Victoria, 3181

  • Local Institution

    Woolloongabba, Queensland, 4102

Other trials in Australia

India17 sites

  • Local Institution

    Ahmedabad, Gujarat, 380006

  • Local Institution

    Ahmedabad, 380015

  • Local Institution

    Bangalore, Karnataka, 560054

  • Local Institution

    Bangalore, 560052

  • Local Institution

    Bangalore, Karnataka, 560034

  • Local Institution

    Bengaluru, Karnataka, 560017

  • Local Institution

    Chennai, Tamil Nadu, 600 006

  • Local Institution

    Chennai, 600 003

  • Local Institution

    Chennai, 600 006

  • Local Institution

    Gurgaon, Haryana, 122001

  • Local Institution

    Hyderabad, Andhra Pradesh, 500 082

  • Local Institution

    Hyderabad, Andhra Pradesh, 500034

  • Local Institution

    Kochi, Kerala, 682041

  • Local Institution

    Ludhiana, Tagore Nagar, 141001

  • Local Institution

    Mohali, Punjab, 160062

  • Local Institution

    New Dehli, New Dehli, 110025

  • Local Institution

    Pune, Maharashtra, 411001

Other trials in India

Canada16 sites

  • Local Institution

    Edmonton, Alberta, T5H 4B9

  • Local Institution

    Edmonton, Alberta, T5X 3N5

  • Local Institution

    Edmonton, Alberta, Tsa 4l8

  • Local Institution

    Hamilton, Ontario, L8L 2X2

  • Local Institution

    Hamilton, Ontario, L8S 4K1

  • Local Institution

    Kelowna, British Columbia, V1Y 9L8

  • Local Institution

    Montreal, Quebec, H1T 2M4

  • Local Institution

    Montreal, Quebec, H3G 1A4

  • Local Institution

    Montreal, Quebec, H3T 1M5

  • Local Institution

    Pointe-Claire, Quebec, H9R 3J1

  • Local Institution

    Québec, Quebec, G1V 4G5

  • Local Institution

    Saint-Jérôme, Quebec, J7Z 5T3

  • Local Institution

    Toronto, Ontario, M5G 2C4

  • Local Institution

    Victoria, British Columbia, V8R 4R2

  • Local Institution

    Waterloo, Ontario, N2J 1C4

  • Local Institution

    Windsor, Ontario, N8X 5A6

Other trials in Canada

France15 sites

  • Local Institution

    Arras, 62022

  • Local Institution

    Besançon, 25000

  • Local Institution

    Brest, 29609

  • Local Institution

    Clamart, 92141

  • Local Institution

    Clermont-Ferrand, 63003

  • Local Institution

    Dijon, 21079

  • Local Institution

    Grenoble, 38043

  • Local Institution

    Le Kremlin-Bicêtre, 94275

  • Local Institution

    Lille, 59020

  • Local Institution

    Limoges, 87042

  • Local Institution

    Lyon, 69437

  • Local Institution

    Nantes, 44093

  • Local Institution

    Saint-Priest-en-Jarez, 42270

  • Local Institution

    Toulouse, 31059

  • Local Institution

    Vernon, 27200

Other trials in France

Israel14 sites

  • Local Institution

    Afula, 18101

  • Local Institution

    Giv‘atayim, 53488

  • Local Institution

    Hadera, 38101

  • Local Institution

    Haifa, 31048

  • Local Institution

    Haifa, 31096

  • Local Institution

    Holon, 58100

  • Local Institution

    Jerusalem, 91031

  • Local Institution

    Kfar Saba, 44281

  • Local Institution

    Kiryat Hadassah, 91120

  • Local Institution

    Nahariya, 22100

  • Local Institution

    Petah Tikva, 49100

  • Local Institution

    Safed, 13100

  • Local Institution

    Tel Aviv, 64239

  • Local Institution

    Tel HaShomer, 52621

Other trials in Israel

Czechia13 sites

  • Local Institution

    Kladno, 272 59

  • Local Institution

    Litomyšl, 570 14

  • Local Institution

    Městec Králové, 289 03

  • Local Institution

    Ostrava Vitkovice, 703 00

  • Local Institution

    Pilsen, 323 33

  • Local Institution

    Prague, 110 00

  • Local Institution

    Prague, 118 33

  • Local Institution

    Prague, 120 00

  • Local Institution

    Prague, 121 11

  • Local Institution

    Prague, 128 08

  • Local Institution

    Prague, 140 21

  • Local Institution

    Prague, 158 00

  • 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

South Africa11 sites

  • Local Institution

    Bellville, Western Cape, 7530

  • Local Institution

    Bloemfontein, 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, 0083

  • Local Institution

    Pretoria, Gauteng, 0084

  • Local Institution

    Somerset West, Western Cape, 7130

  • Local Institution

    Worcester, Western Cape, 6850

Other trials in South Africa

United Kingdom10 sites

  • Local Institution

    Aberdeen, Aberdeenshire, AB25 2ZN

  • Local Institution

    Bury St Edmunds, Suffolk, IP30 9QU

  • Local Institution

    Coventry, West Midlands, CV2 2DX

  • Local Institution

    Dudley, West Midlands, DY1 2HQ

  • Local Institution

    Hull, Humberside, HU3 2JZ

  • Local Institution

    London, Greater London, SE5 9RS

  • Local Institution

    London, Greater London, SW17 0QT

  • Local Institution

    Manchester, Greater Manchester, M23 9LT

  • Local Institution

    Nottingham, Nottinghamshire, NG7 2UH

  • Local Institution

    Romford, Essex, RM7 0AG

Other trials in United Kingdom

Denmark9 sites

  • Local Institution

    Arhus C, 8000

  • Local Institution

    Brædstrup, 8740

  • Local Institution

    Esbjerg, 6700

  • Local Institution

    Frederiksberg, 2000

  • Local Institution

    Hellerup, 2900

  • Local Institution

    Herning, 7400

  • Local Institution

    Hilleroed, 3400

  • Local Institution

    Næstved, 4700

  • Local Institution

    Silkeborg, 8600

Other trials in Denmark

Chile8 sites

  • Local Institution

    Independencia, Santiago Metropolitan, XXXXX

  • Local Institution

    Punta Arenas, Magallanes Antartica, 6212296

  • Local Institution

    Santiago, Santiago Metropolitan, 7500520

  • Local Institution

    Santiago, Santiago Metropolitan, 7600448

  • Local Institution

    Santiago, Santiago Metropolitan, 7980378

  • Local Institution

    Santiago, Santiago Metropolitan, 8330024

  • Local Institution

    Temuco, Araucania, 4781173

  • Local Institution

    Viña del Mar, Valparaiso, 2520000

Other trials in Chile

Norway6 sites

  • Local Institution

    Ålesund, 6026

  • Local Institution

    Fredrikstad, 1606

  • Local Institution

    Gjettum, 1346

  • Local Institution

    Gjøvik, 2819

  • Local Institution

    Hamar, 2318

  • Local Institution

    Oslo, 0407

Other trials in Norway

South Korea6 sites

  • Local Institution

    Busan, 602-702

  • Local Institution

    Jongno-Gu, 110-774

  • Local Institution

    Seoul, 120752

  • Local Institution

    Seoul, 135-710

  • Local Institution

    Seoul, 137-040

  • Local Institution

    Seoul, 138736

Other trials in South Korea

Austria5 sites

  • Local Institution

    Graz, 8036

  • Local Institution

    Innsbruck, A-6020

  • Local Institution

    Vienna, 1090

  • Local Institution

    Vienna, 1100

  • Local Institution

    Vienna, 1140

Other trials in Austria

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

Philippines4 sites

  • Local Institution

    Cavite, 4114

  • Local Institution

    Davao City, 8000

  • Local Institution

    Pasig, 1600

  • Local Institution

    Quezon City, 1102

Other trials in Philippines

Hong Kong2 sites

  • Local Institution

    Hong Kong

  • Local Institution

    Shatin, N.T

Other trials in Hong Kong

Portugal2 sites

  • Local Institution

    Guarda, 6301-857

  • Local Institution

    Lisbon, 1769-001

Other trials in Portugal

Puerto Rico2 sites

  • Local Institution

    San Juan, 00909

  • Local Institution

    San Juan, 00921

Other trials in Puerto Rico

Singapore2 sites

  • Local Institution

    Singapore, 169608

  • Local Institution

    Singapore, 308433

Other trials in Singapore

About this study

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

The purpose is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients who have completed their intended treatment for deep vein thrombosis (DVT) or pulmonary embolism (PE)

Being tested
Apixaban, Placebo
Medical subject headings
Venous Thrombosis

What participants receive

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

  • ApixabanDrug

    Also called BMS-562247

    Tablets, Oral, twice daily, 12 months

  • PlaceboDrug

    Tablets, Oral, twice daily, 12 months

Study groups in NCT00633893
Study groupRoleWhat they receive
1Experimental2.5 mg
Receives: Drug: Apixaban
2Experimental5.0 mg
Receives: Drug: Apixaban
3Active comparator0 mg
Receives: Drug: Placebo

What is being measured

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

  1. Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation

    VTE included: nonfatal deep vein thrombosis (DVT) or nonfatal pulmonary embolism (PE). All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee 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 events; N=number of 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. For missing endpoint data, participants were imputed as having had a primary efficacy outcome event.

    Measured: Day 1 up to 12 Months

  2. Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation

    VTE included: nonfatal DVT or nonfatal PE. Event rate (proportion of participants with event) calculated as n/N (n=number of events; N=number of 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. No imputation was done for these endpoints; participants who had an event during the intended treatment period were counted. Confidence interval (CI) for single event rate was calculated based on the Wald asymptotic confidence limits.

    Measured: Day 1 up to 12 months

Secondary outcomes (20)

  1. Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or VTE-related Death During the Intended Treatment Period - Randomized Population With Imputation

    VTE includes nonfatal DVT or nonfatal PE. All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee 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 events; N=number of 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. For missing endpoint data, participants were imputed as having had a primary efficacy outcome event.

    Measured: Day 1 up to 12 Months

  2. Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Cardio Vascular (CV) -Related Death During the Intended Treatment Period - Randomized Population With Imputation

    VTE includes nonfatal DVT or nonfatal PE. All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee 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 is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Composite endpoint included events that occurred any time from randomization until end of the intended treatment period, regardless of whether the participants were receiving drug treatment. Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. If there were missing endpoint data, participants were imputed as having had an efficacy outcome event.

    Measured: Day 1 up to 12 Months

  3. Adjudicated Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period - Randomized Population With Imputation

    DVT was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and assessed by compression ultrasound and/or venography. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. Participants with missing endpoint information were classified as having had the efficacy event (imputation). Confidence interval (CI) for single event rate was calculated based on the Wald asymptotic confidence limits.

    Measured: Day 1 up to 12 Months

  4. Adjudicated Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period - Randomized Population With Imputation

    PE was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. Participants with missing endpoint information were classified as having had the efficacy event (imputation). CI for single event rate was calculated based on the Wald asymptotic confidence limits.

    Measured: Day 1 up to 12 Months

  5. Adjudicated Venous Thromboembolism (VTE) - Related Death During the Intended Treatment Period - Randomized Population With Imputation

    VTE-related death defined as: PE (based on objective diagnostic testing, autopsy), unexplained death (and VTE cannot be ruled out), sudden death (and VTE cannot be ruled out). DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee 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. New/recurrent VTE, death, venous/arterial thromboembolic events, bleeding, thrombocytopenia, acute myocardial infarction and stroke were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Participants with missing endpoint information were classified as having had the efficacy event (imputation).

    Measured: Day 1 up to 12 Months

  6. Adjudicated Cardiovascular (CV)-Related Death During the Intended Treatment Period - Randomized Population With Imputation

    CV-related death was defined as myocardial infarction, stroke, or other specified cardiovascular event and were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. Participants with missing endpoint information were classified as having had the efficacy event (imputation). CI for single event rate was calculated based on the Wald asymptotic confidence limits.

    Measured: Day 1 up to 12 Months

  7. Adjudicated All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation

    DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee 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. New/recurrent VTE, death, venous/arterial thromboembolic events, bleeding, thrombocytopenia, acute myocardial infarction and stroke were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Participants with missing endpoint information were classified as having had the efficacy event (imputation). CI for single event rate was calculated based on the Wald asymptotic confidence limits.

    Measured: Day 1 up to 12 Months

  8. Number of Participants With an Adjudicated Symptomatic Nonfatal Venous Thromboembolism (VTE) Recurrence or Death (All Cause) During the Intended Treatment Period - Randomized Participants Without Imputation

    All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee 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. Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. First event category was the first primary event for each participant and each participant was counted once. CV-related death was presented excluding VTE-related death. In participants with event category, each participant was counted once in each event category but could have been counted in multiple categories. No imputation was done for these endpoints; participants who had an event during the intended treatment period were counted.

    Measured: Day 1 up to 12 Months

  9. Adjudicated Major Bleeding During the Treatment Period - Treated Population

    Major bleeding was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and was defined as acute clinically overt bleeding: associated with a fall in hemoglobin of 2 grams per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 milliliters (mL) or more of whole blood, or in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or another critical organ; or is fatal. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Confidence interval (CI) for event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.

    Measured: Day 1 up to 12 Months

  10. Adjudicated Composite of Major/Clinically Relevant Non-major Bleeding During the Treatment Period - Treated Participants

    Major bleeding and clinically relevant non-major bleeding were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Major bleeding was defined as acute clinically overt bleeding: associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 mL or more of whole blood, or in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or another critical organ or is fatal. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). CI for single event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.

    Measured: Day 1 up to 12 Months

  11. Adjudicated Clinically Relevant Non-major Bleeding During the Treatment Period - Treated Participants

    Non-major clinically relevant bleeding was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and defined as: acute clinically overt bleeding compromising hemodynamics; leading to hospitalization; traumatic subcutaneous hematoma; intramuscular hematoma; epistaxis that lasted for more than 5 minutes, was repetitive or led to an intervention; spontaneous gingival bleeding (or lasting more than 5 minutes); spontaneous hematuria (macroscopic or lasted more than 24 hours after instrumentation of the urogenital tract); macroscopic gastrointestinal hemorrhage (including at least 1 episode of melena or hematemesis (if clinically apparent with positive results on a fecal occult-blood test); rectal blood loss. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). CI for single event rate was calculated based on the Wald asymptotic confidence limits.

    Measured: Day 1 up to 12 months

  12. Adjudicated Clinically Relevant Minor Bleeding During the Treatment Period - Treated Participants

    All bleeding events were reviewed by the central independent adjudication committee blinded to treatment and classified as major bleeding, clinically relevant non-major bleeding, minor bleeding or no bleeding. If event was not major or clinically relevant non-major, it was judged to be minor. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Confidence interval (CI) for single event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.

    Measured: Day 1 up to 12 months

  13. Adjudicated Total Bleeding During the Treatment Period - Treated Participants

    All bleeding events were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Total bleeding was defined as any major, clinically relevant non-major, or minor bleeding. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). CI for single event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.

    Measured: Day 1 up to 12 months

  14. Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Venous Thromboembolism-related Death During the Intended Treatment Period - Randomized Population Without Imputation

    VTE related death defined as PE (based on objective diagnostic testing, autopsy), unexplained death (and VTE cannot be ruled out), sudden death (and VTE cannot be ruled out). DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee 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. New/recurrent VTE and death, were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for these endpoints.

    Measured: Day 1 up to 12 Months

  15. Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Cardio Vascular (CV) - Related Death During the Intended Treatment Period - Randomized Population Without Imputation

    CV-related death was defined as myocardial infarction, stroke, or other specified cardiovascular event. Index events of DVT and/or PE, along with myocardial infarction and stroke were adjudicated/confirmed by a central independent adjudication committee 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 is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for these endpoints; participants who had an event during the intended treatment period were counted.

    Measured: Day 1 up to 12 Months

  16. Adjudicated Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period - Randomized Population Without Imputation

    DVT was adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.

    Measured: Day 1 up to 12 Months

  17. Adjudicated Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period - Randomized Population Without Imputation

    PE was adjudicated/confirmed by a central independent adjudication committee blinded to treatment: PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.

    Measured: Day 1 up to 12 Months

  18. Adjudicated Venous Thromboembolism (VTE)- Related Death During the Intended Treatment Period - Randomized Population Without Imputation

    VTE related death defined as PE (based on objective diagnostic testing, autopsy), unexplained death (and VTE cannot be ruled out), sudden death (and VTE cannot be ruled out). DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee 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. New/recurrent VTE, and death, were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint.

    Measured: Day 1 up to 12 Months

  19. Adjudicated Cardio Vascular (CV)-Related Death During the Intended Treatment Period - Randomized Population Without Imputation

    CV-related death was defined as myocardial infarction, stroke, or other specified cardiovascular event and these were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.

    Measured: Day 1 up to 12 Months

  20. Adjudicated All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation

    DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee 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. New/recurrent VTE, death, venous/arterial thromboembolic events, bleeding, thrombocytopenia, acute myocardial infarction and stroke were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.

    Measured: Day 1 up to 12 Months

Timeline

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

  1. First posted12 Mar 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionAug 2012
  4. Study completionAug 2012

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
2,711 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00633893
Sponsor's protocol ID
CV185-057
Other IDs
EUDRACT: 2007-004953-27
Status last verified
Oct 2013
First submitted
5 Mar 2008
Last updated
25 Nov 2013
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

  • Liu X, Thompson J, Phatak H, Mardekian J, Porcari A, Johnson M, Cohen AT. Extended anticoagulation with apixaban reduces hospitalisations in patients with venous thromboembolism. An analysis of the AMPLIFY-EXT trial. Thromb Haemost. 2016 Jan;115(1):161-8. doi: 10.1160/TH15-07-0606. Epub 2015 Oct 8.

    PubMed 26446706

  • Agnelli G, Buller HR, Cohen A, Curto M, Gallus AS, Johnson M, Porcari A, Raskob GE, Weitz JI; AMPLIFY-EXT Investigators. Apixaban for extended treatment of venous thromboembolism. N Engl J Med. 2013 Feb 21;368(8):699-708. doi: 10.1056/NEJMoa1207541. Epub 2012 Dec 8.

    PubMed 23216615

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Apixaban in people with Venous Thrombosis, run by Bristol-Myers Squibb at 428 sites in 29 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 4 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 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 428 sites in United States, Brazil, Poland, Italy, Argentina and 24 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 25 Oct 2013). 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?

Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation (time frame: Day 1 up to 12 Months). 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 NCT00633893, which also lists 3 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 25 Nov 2013.

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