AzTrials
AzTrials

Venous ThromboembolismPhase 3NCT00439725

Once - Daily Oral Direct Factor Xa Inhibitor Rivaroxaban In The Long-Term Prevention Of Recurrent Symptomatic Venous Thromboembolism In Patients With Symptomatic Deep-Vein Thrombosis Or Pulmonary Embolism. The Einstein-Extension Study

A Phase 3 study testing Rivaroxaban (Xarelto, BAY59-7939) in people with Venous Thromboembolism, run by Bayer at 322 sites in 33 countries.

Completed

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

Official record
Search all trials

Trial summary

This is a multicenter, randomized, double-blind, placebo-controlled, event-driven, superiority study for efficacy. Patients with confirmed symptomatic DVT (deep vein thrombosis) or PE (pulmonary embolism) who completed 6 or 12 months of treatment with rivaroxaban or VKA (vitamin K antagonist) are eligible for this… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Venous Thromboembolism
What is being tested?
Rivaroxaban (Xarelto, BAY59-7939)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,197 participants
Where
322 sitesin 33 countries
Study dates
Feb 2007to Sep 2009
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

  • Patients with confirmed symptomatic PE or DVT who have been treated for 6 or 12 months with VKA or rivaroxaban

Who cannot join

  • Legal lower age limitations (country specific)
  • Indication for VKA other than DVT and/or PE
  • Patients in whom anticoagulant treatment for their index PE or DVT should be continued
  • Childbearing potential without proper contraceptive measures, pregnancy or breast feeding. Proper contraceptive measures are defined as a method of contraception with a failure rate < 1 % during the course of the study (including the observational period). These methods of contraception according to the note for guidance on non-clinical safety studies for the conduct of human trials for pharmaceuticals (CPMP [Committee for Proprietary Medicinal Products]/ICH [International Conference on Harmonization]/286/95, modification) include consistent and correct use of hormone containing implants and injectables, combined oral contraceptives, hormone containing intrauterine devices, surgical sterilization, sexual abstinence and vasectomy

Trial locations and contacts

322 sites in 33 countries.

322 sites in 33 countries

France35 sites

  • Study site

    Agen, 47923

  • Study site

    Amiens, 80000

  • Study site

    Angers, 49033

  • Study site

    Arras, 62000

  • Study site

    Bordeaux, 33075

  • Study site

    Brest, 29609

  • Study site

    Castelnau-le-Lez, 34170

  • Study site

    Clamart, 92141

  • Study site

    Clermont-Ferrand, 63000

  • Study site

    Colombes, 92700

  • Study site

    Créteil, 94000

  • Study site

    Dijon, 21000

  • Study site

    Grenoble, 38028

  • Study site

    Grenoble, 38043

  • Study site

    Lille, 59037

  • Study site

    Limoges, 87042

  • Study site

    Montpellier, 34295

  • Study site

    Nantes, 44000

  • Study site

    Nîmes, 30029

  • Study site

    Orthez, 64300

  • Study site

    Paris, 75004

  • Study site

    Paris, 75475

  • Study site

    Paris, 75877

  • Study site

    Paris, 75908

  • Study site

    Pierre-Bénite, 69495

  • Study site

    Roanne, 42328

  • Study site

    Rouen, 76031

  • Study site

    Saint-Etienne, 42055

  • Study site

    Strasbourg, 67091

  • Study site

    Toulon, 83000

  • Study site

    Toulouse, 31403

  • Study site

    Tours, 37044

  • Study site

    Valenciennes, 59322

  • Study site

    Vandœuvre-lès-Nancy, 54511

  • Study site

    Vernon, 27200

Other trials in France

Germany32 sites

  • Study site

    Augsburg, Bavaria, 86156

  • Study site

    Berlin, State of Berlin, 10713

  • Study site

    Berlin, State of Berlin, 12099

  • Study site

    Bruchsal, Baden-Wurttemberg, 76646

  • Study site

    Darmstadt, Hesse, 64297

  • Study site

    Dresden, Saxony, 01307

  • Study site

    Düsseldorf, North Rhine-Westphalia, 40225

  • Study site

    Essen, North Rhine-Westphalia, 45122

  • Study site

    Frankfurt am Main, Hesse, 60596

  • Study site

    Giessen, Hesse, 35392

  • Study site

    Greifswald, Mecklenburg-Vorpommern, 17475

  • Study site

    Halle, Saxony-Anhalt, 06120

  • Study site

    Hamburg, Free and Hanseatic City of Hamburg, 20251

  • Study site

    Hanover, Lower Saxony, 30625

  • Study site

    Heidelberg, Baden-Wurttemberg, 69115

  • Study site

    Homburg, Saarland, 66421

  • Study site

    Homburg, Saarland, 66424

  • Study site

    Karlsbad, Baden-Wurttemberg, 76307

  • Study site

    Leipzig, Saxony, 04289

  • Study site

    Magdeburg, Saxony-Anhalt, 39112

  • Study site

    Mainz, Rhineland-Palatinate, 55131

  • Study site

    Mannheim, Baden-Wurttemberg, 68167

  • Study site

    München, Bavaria, 80331

  • Study site

    München, Bavaria, 81377

  • Study site

    Neckargemünd, Baden-Wurttemberg, 69151

  • Study site

    Paderborn, North Rhine-Westphalia, 33098

  • Study site

    Rotenburg (Wümme), Lower Saxony, 27342

  • Study site

    Soest, North Rhine-Westphalia, 59494

  • Study site

    Tübingen, Baden-Wurttemberg, 72076

  • Study site

    Wiesbaden, Hesse, 65183

  • Study site

    Witten, North Rhine-Westphalia, 58455

  • Study site

    Würzburg, Bavaria, 97080

Other trials in Germany

United States25 sites

  • Study site

    Albuquerque, New Mexico, 87108

  • Study site

    Baltimore, Maryland, 21215-5271

  • Study site

    Bay Pines, Florida, 33744

  • Study site

    Boston, Massachusetts, 02215

  • Study site

    Burlington, Vermont, 05401

  • Study site

    Chapel Hill, North Carolina, 27599-7035

  • Study site

    Corsicana, Texas, 75110

  • Study site

    Covington, Louisiana, 70433

  • Study site

    Decatur, Georgia, 30033

  • Study site

    Fredericksburg, Virginia, 22401

  • Study site

    Greensboro, North Carolina, 27401

  • Study site

    Greensboro, North Carolina, 27403

  • Study site

    Idaho Falls, Idaho, 83404

  • Study site

    Little Rock, Arkansas, 72205

  • Study site

    Los Angeles, California, 90095

  • Study site

    Melbourne, Florida, 32901

  • Study site

    Miami, Florida, 33136-1096

  • Study site

    Miami, Florida, 33136

  • Study site

    Murray, Utah, 84107

  • Study site

    Oklahoma City, Oklahoma, 73104

  • Study site

    Pittsburgh, Pennsylvania, 15224

  • Study site

    Redlands, California, 92373

  • Study site

    Salt Lake City, Utah, 84132

  • Study site

    San Antonio, Texas, 78229

  • Study site

    Spokane, Washington, 99204

Other trials in United States

Australia23 sites

  • Study site

    Adelaide, South Australia, 5011

  • Study site

    Adelaide, South Australia, 5042

  • Study site

    Box Hill, Victoria, 3128

  • Study site

    Brisbane, Queensland, 4029

  • Study site

    Clayton, Victoria, 3168

  • Study site

    Fremantle, Western Australia, 6160

  • Study site

    Garran, Australian Capital Territory, 2605

  • Study site

    Geelong, Victoria, 3220

  • Study site

    Gosford, New South Wales, 2250

  • Study site

    Kogarah, New South Wales, 2217

  • Study site

    Lismore, New South Wales, 2480

  • Study site

    Melbourne, Victoria, 3135

  • Study site

    Melbourne, Victoria, 3181

  • Study site

    Perth, Western Australia, 6000

  • Study site

    Prahran, Victoria, 3181

  • Study site

    Redcliffe, Queensland, 4020

  • Study site

    Southport, Queensland, 4215

  • Study site

    St Leonards, New South Wales, 2065

  • Study site

    Sydney, New South Wales, 2010

  • Study site

    Sydney, New South Wales, 2031

  • Study site

    Sydney, New South Wales, 2139

  • Study site

    Sydney, New South Wales, 2229

  • Study site

    Woolloongabba, Queensland, 4102

Other trials in Australia

China15 sites

  • Study site

    Beijing, 100020

  • Study site

    Beijing, 100029

  • Study site

    Beijing, 100037

  • Study site

    Beijing, 100038

  • Study site

    Beijing, 100044

  • Study site

    Beijing, 100730

  • Study site

    Beijing, 100853

  • Study site

    Guangzhou, Guangdong, 510080

  • Study site

    Harbin, Heilongjiang, 150086

  • Study site

    Shanghai, 200001

  • Study site

    Shanghai, 200032

  • Study site

    Shanghai, 200433

  • Study site

    Shenyang, Liaoning, 110016

  • Study site

    Suzhou, Jiangsu, 215004

  • Study site

    Wuhan, Hubei, 430022

Other trials in China

Poland15 sites

  • Study site

    Bialystok, 15-276

  • Study site

    Bydgoszcz, 85-168

  • Study site

    Gdansk, 80-952

  • Study site

    Katowice, 40-365

  • Study site

    Krakow, 31-066

  • Study site

    Lodz, 90-153

  • Study site

    Lublin, 20-081

  • Study site

    Poznan, 60-631

  • Study site

    Poznan, 61-848

  • Study site

    Torun, 87-100

  • Study site

    Warsaw, 01-138

  • Study site

    Warsaw, 02-097

  • Study site

    Warsaw, 04-479

  • Study site

    Wroclaw, 50-326

  • Study site

    Wroclaw, 51-124

Other trials in Poland

Belgium13 sites

  • Study site

    Bruxelles - Brussel, 1070

  • Study site

    Bruxelles - Brussel, 1200

  • Study site

    Duffel, 2570

  • Study site

    Genk, 3600

  • Study site

    Ghent, 9000

  • Study site

    Hasselt, 3500

  • Study site

    Leuven, 3000

  • Study site

    Liège, 4000

  • Study site

    Lier, 2500

  • Study site

    Namur, 5000

  • Study site

    Sint-Truiden, 3800

  • Study site

    Yvoir, 5530

  • Study site

    Zottegem, 9620

Other trials in Belgium

Israel13 sites

  • Study site

    Afula, 18101

  • Study site

    Ashkelon, 78278

  • Study site

    Beersheba, 84101

  • Study site

    Haifa, Israel, 34362

  • Study site

    Haifa, 31048

  • Study site

    Haifa, 31096

  • Study site

    Holon, 58100

  • Study site

    Jerusalem, 91120

  • Study site

    Kfar Saba, 44281

  • Study site

    Petah Tikva, Israel, 49100

  • Study site

    Rehovot, 76100

  • Study site

    Safed, 13100

  • Study site

    Tel Aviv, 64239

Other trials in Israel

South Africa12 sites

  • Study site

    Cape Town, Cape, 7500

  • Study site

    Cape Town, Western Cape, 7460

  • Study site

    Johannesburg, Gauteng, 2132

  • Study site

    Johannesburg, Gauteng, 2157

  • Study site

    Johannesburg, Gauteng, 2191

  • Study site

    Johannesburg, Gauteng, 2193

  • Study site

    Pretoria, Gauteng, 0084

  • Study site

    Pretoria, Gauteng, 0157

  • Study site

    Pretoria, Gauteng, 0181

  • Study site

    Roodepoort, Gauteng, 1724

  • Study site

    Somerset West, Western Cape, 7130

  • Study site

    Worcester, Western Cape, 6850

Other trials in South Africa

Brazil11 sites

  • Study site

    Botucatu, São Paulo, 18618 000

  • Study site

    Curitiba, Paraná, 80050-350

  • Study site

    Londrina, Paraná, 86038440

  • Study site

    Porto Alegre, Rio Grande do Sul

  • Study site

    Rio de Janeiro

  • Study site

    São Paulo, São Paulo, 01323-001

  • Study site

    São Paulo, São Paulo, 01509-900

  • Study site

    São Paulo, São Paulo, 04023-061

  • Study site

    São Paulo, São Paulo, 04039-004

  • Study site

    Sorocaba, São Paulo, 18031-000

  • Study site

    Uberaba, Minas Gerais, 38010 380

Other trials in Brazil

Italy11 sites

  • Study site

    Bologna, 40138

  • Study site

    Chieti, 66013

  • Study site

    Milan, 20132

  • Study site

    Milan, 20142

  • Study site

    Naples, 80131

  • Study site

    Padova, 35128

  • Study site

    Palermo, 90127

  • Study site

    Parma, 43100

  • Study site

    Pavia, 27100

  • Study site

    Piacenza, 29100

  • Study site

    Venezia, 30122

Other trials in Italy

Netherlands11 sites

  • Study site

    's-Hertogenbosch, 5223 GZ

  • Study site

    Amsterdam, 1105 AZ

  • Study site

    Arnhem, 6815 AD

  • Study site

    Dordrecht, 3318 AT

  • Study site

    Enschede, 7511 JX

  • Study site

    Groningen, 9713 GZ

  • Study site

    Hoofddorp, 2134 TM

  • Study site

    Maastricht, 6229 HX

  • Study site

    Rotterdam, 3083 AN

  • Study site

    Zwijndrecht, 3331 LZ

  • Study site

    Zwolle, 8025 AB

Other trials in Netherlands

Czechia10 sites

  • Study site

    Brno, 65691

  • Study site

    Karlovy Vary, 360 00

  • Study site

    Kladno, 27259

  • Study site

    Ostrava, 728 80

  • Study site

    Ostrava-Poruba, 708 52

  • Study site

    Prague, 110 00

  • Study site

    Prague, 12800

  • Study site

    Prague, 140 21

  • Study site

    Prague, 150 00

  • Study site

    Usti Nad Lebem, 401 13

Other trials in Czechia

United Kingdom10 sites

  • Study site

    Chelmsford, Essex, CM1 5ET

  • Study site

    Edinburgh, Lothian, EH16 4SA

  • Study site

    Isleworth, London, TW7 6AF

  • Study site

    Liverpool, Merseyside, L7 8XP

  • Study site

    London, London, SE1 7EH

  • Study site

    London, London, SE5 9RS

  • Study site

    London, W1T 4EU

  • Study site

    London

  • Study site

    Plymouth, Devon, PL6 8DH

  • Study site

    Romford, Essex, RM7 0AG

Other trials in United Kingdom

Hungary9 sites

  • Study site

    Budapest, 1096

  • Study site

    Budapest, 1115

  • Study site

    Debrecen, 4032

  • Study site

    Kecskemét, 6000

  • Study site

    Kistarcsa, 2143

  • Study site

    Miskolc, 3526

  • Study site

    Nyíregyháza, 4400

  • Study site

    Szentes, 6600

  • Study site

    Szombathely, 9700

Other trials in Hungary

India9 sites

  • Study site

    Hyderabad, 500082

  • Study site

    Kochi, Kerala, 682026

  • Study site

    Kolkata, 700029

  • Study site

    Mumbai, Maharashtra, 400008

  • Study site

    Mumbai, Maharashtra, 400016

  • Study site

    Mumbai, Maharashtra, 400022

  • Study site

    New Delhi, 110060

  • Study site

    Pune, 411001

  • Study site

    Vellore, Kerala, 632004

Other trials in India

Spain9 sites

  • Study site

    Alcorcón, Madrid, 28922

  • Study site

    Barcelona, Barcelona, 08025

  • Study site

    Barcelona, Barcelona, 08036

  • Study site

    Fuenlabrada, Madrid, 28942

  • Study site

    Girona, Girona, 17007

  • Study site

    Madrid, Madrid, 28034

  • Study site

    Pamplona, Pamplona, 31008

  • Study site

    Terrassa, Barcelona, 08221

  • Study site

    Xàtiva, Valencia, 46800

Other trials in Spain

Switzerland7 sites

  • Study site

    Brig, Valais, 3900

  • Study site

    Bruderholz, Basel-Landschaft, 4101

  • Study site

    Chur, Kanton Graubünden, 7000

  • Study site

    Genéve 14, Genève 14, 1211

  • Study site

    Lucerne, 6000

  • Study site

    Lugano, 6903

  • Study site

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

Austria6 sites

  • Study site

    Feldkirch, Vorarlberg, 6807

  • Study site

    Graz, Styria, 8036

  • Study site

    Innsbruck, Tyrol, 6020

  • Study site

    Salzburg, State of Salzburg, 5020

  • Study site

    Vienna, State of Vienna, 1090

  • Study site

    Vienna, State of Vienna, 1140

Other trials in Austria

South Korea6 sites

  • Study site

    Daegu, Daegu Gwang'yeogsi, 700721

  • Study site

    Daegu, 705-718

  • Study site

    Seoul, Seoul Teugbyeolsi, 110-744

  • Study site

    Seoul, 120-752

  • Study site

    Seoul, 137-701

  • Study site

    Taegu, 700-712

Other trials in South Korea

Sweden6 sites

  • Study site

    Borås, 501 82

  • Study site

    Gothenburg, 413 45

  • Study site

    Gothenburg, 416 85

  • Study site

    Jönköping, 551 85

  • Study site

    Sundsvall, 851 86

  • Study site

    Västervik, 593 81

Other trials in Sweden

New Zealand5 sites

  • Study site

    Auckland, 0622

  • Study site

    Auckland, 1023

  • Study site

    Christchurch, 8011

  • Study site

    Palmerston North, 4414

  • Study site

    Wellington South, 6021

Other trials in New Zealand

Taiwan5 sites

  • Study site

    Kaohsiung City, 80756

  • Study site

    Tainan, 704

  • Study site

    Taipei, 10002

  • Study site

    Taipei, 11217

  • Study site

    Taoyuan, 333

Other trials in Taiwan

Denmark4 sites

  • Study site

    Aarhus C, 8000

  • Study site

    Brædstrup, 8740

  • Study site

    Frederiksberg, 2000F

  • Study site

    Hellerup, 2900

Other trials in Denmark

Indonesia4 sites

  • Study site

    Bandung, 40161

  • Study site

    Jakarta, 10430

  • Study site

    Medan, 20152

  • Study site

    Semarang, 50241

Other trials in Indonesia

Norway4 sites

  • Study site

    Fredrikstad, 1603

  • Study site

    Oslo, 0407

  • Study site

    Oslo, 0514

  • Study site

    Rud, 1309

Other trials in Norway

Thailand3 sites

  • Study site

    Bangkok, Bangkok, 10700

  • Study site

    Bangkok, 10400

  • Study site

    Pathumwan, Bangkok, Thailand, 10330

Other trials in Thailand

Canada2 sites

  • Study site

    Toronto, Ontario, M6R 1B5

  • Study site

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

Philippines2 sites

  • Study site

    Quezon City, 0850

  • Study site

    Quezon City, 1102

Other trials in Philippines

Singapore2 sites

  • Study site

    Singapore, 169608

  • Study site

    Singapore, 308433

Other trials in Singapore

Finland1 site

  • Study site

    Seinäjoki, 60220

Other trials in Finland

Hong Kong1 site

  • Study site

    Hong Kong

Other trials in Hong Kong

Malaysia1 site

  • Study site

    Kuala Selangor, 68000

Other trials in Malaysia

About this study

Official title: Once-daily Oral Direct Factor Xa Inhibitor Rivaroxaban in the Long-term Prevention of Recurrent Symptomatic Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis or Pulmonary Embolism. The Einstein-Extension Study

This is a multicenter, randomized, double-blind, placebo-controlled, event-driven, superiority study for efficacy. Patients with confirmed symptomatic DVT (deep vein thrombosis) or PE (pulmonary embolism) who completed 6 or 12 months of treatment with rivaroxaban or VKA (vitamin K antagonist) are eligible for this trial (Einstein-Extension study).

Read the detailed description

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

The treatment period was followed by an observational period of 30 days starting the day after the last intake of study medication, regardless of the actual duration of study drug administration. Participants who did not complete the treatment period also entered the observational period. It was also possible that participants did not enter the observational period, e.g. due to withdrawal of consent or termination of study participation.

Being tested
Rivaroxaban (Xarelto, BAY59-7939), Placebo
Medical subject headings
Venous Thromboembolism

What participants receive

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

  • Rivaroxaban (Xarelto, BAY59-7939)Drug

    Patients randomized to rivaroxaban will receive rivaroxaban 20 mg once-daily.

  • PlaceboDrug

    Patients allocated to placebo will receive a matching placebo tablet once daily.

Study groups in NCT00439725
Study groupRoleWhat they receive
Rivaroxaban (Xarelto, BAY59-7939)ExperimentalParticipants were to receive rivaroxaban 20 mg oral tablet once daily
Receives: Drug: Rivaroxaban (Xarelto, BAY59-7939)
PlaceboPlacebo comparatorParticipants were to receive matching placebo oral tablet once daily
Receives: Drug: Placebo

What is being measured

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

  1. Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment

    All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), and/or case summaries. For definition of DVT/PE, kindly refer to the link in the Protocol section.

    Measured: 6- or 12-month study treatment period

Secondary outcomes (9)

  1. Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality Until the Intended End of Study Treatment

    All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), or lung scintigraphy (for PE), and/or case summaries.

    Measured: 6- or 12-month study treatment period

  2. Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE, All Cause Mortality, Strokes and Myocardial Infarctions Until the Intended End of Study Treatment

    All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), results/films/images of confirmatory testing, and/or case summaries.

    Measured: 6- or 12-month study treatment period

  3. Percentage of Participants With Net Clinical Benefit as Composite of Recurrent DVT or Non-fatal or Fatal PE and Major Bleeding Events Until the Intended End of Study Treatment

    All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death.

    Measured: 6- or 12-month study treatment period

  4. Percentage of Participants With Recurrent VTE (PE or DVT) Until the Intended End of Study Treatment

    All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), results/films/images of confirmatory testing, and/or case summaries.

    Measured: 6- or 12-month study treatment period

  5. Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment

    All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound, venography, results/films/images of confirmatory testing, and/or case summaries.

    Measured: 6- or 12-month study treatment period

  6. Percentage of Participants With Major Bleeding

    All events were adjudicated and confirmed by a central independent adjudication committee (CIAC) blinded to treatment. Major bleeding event was overt bleeding associated with a 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death. Treatment-emergent [after intake of first tablet of study medication as randomized but not more than 2 days after stop of study medication (referred to as time window: 2 days)] events and all events post randomization were reported.

    Measured: 6- or 12-month study treatment period

  7. Percentage of Participants With Clinically Relevant Bleeding

    All events adjudicated/confirmed by CIAC blinded to treatment. Clinically relevant bleeding included major bleeding (definition: see outcome 7) and non-major bleeding associated with medical intervention, unscheduled physician contact, (temporary) cessation of study treatment, discomfort for the participants such as pain, or impairment of daily life activities. Treatment-emergent events (after intake of 1st study medication tablet as randomized up to 2 days after stop of study medication ['time window: 2 days']) and all events post randomization were reported

    Measured: 6- or 12-month study treatment period

  8. Percentage of Participants With All Death

    All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either autopsy, results/films/images of confirmatory testing, and/or case summaries. Treatment-emergent events and all events post randomization were reported. Treatment-emergent: after intake of first tablet of study medication as randomized but not more than 2 days after stop of study medication (referred to as time window: 2 days)

    Measured: 6- or 12-month study treatment period

  9. Percentage of Participants With Other Vascular Events

    All pre-defined vascular events (acute coronary syndromes, ischemic stroke, transient ischemic attack, non-central nervous system systemic embolism and vascular death) were adjudicated/confirmed by a central independent adjudication committee blinded to treatment, based on results/films/images of confirmatory testing, and/or case summaries. On treatment events and all events post randomization were reported. On treatment: after intake of first tablet of study medication as randomized but not more than 1 day after stop of study medication (referred to as time window: 1 day)

    Measured: 6- or 12-month study treatment period

Timeline

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

  1. First posted26 Feb 2007 (estimated)
  2. Study startFeb 2007
  3. Primary completionAug 2009
  4. Study completionSep 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,197 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00439725
Sponsor's protocol ID
11899
Other IDs
2006-004494-96
Status last verified
Oct 2014
First submitted
23 Feb 2007
Last updated
4 Nov 2014
Data monitoring committee
No

Publications

  • Cohen AT, Dobromirski M. The use of rivaroxaban for short- and long-term treatment of venous thromboembolism. Thromb Haemost. 2012 Jun;107(6):1035-43. doi: 10.1160/TH11-12-0859. Epub 2012 Feb 28.

    PubMed 22371186

  • EINSTEIN Investigators; Bauersachs R, Berkowitz SD, Brenner B, Buller HR, Decousus H, Gallus AS, Lensing AW, Misselwitz F, Prins MH, Raskob GE, Segers A, Verhamme P, Wells P, Agnelli G, Bounameaux H, Cohen A, Davidson BL, Piovella F, Schellong S. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010 Dec 23;363(26):2499-510. doi: 10.1056/NEJMoa1007903. Epub 2010 Dec 3.

    PubMed 21128814

  • Dobesh PP, Volkl AA, Pap AF, Damaraju CV, Levitan B, Yuan Z, Amin AN. Benefit-Risk Assessment of Rivaroxaban in Older Patients With Nonvalvular Atrial Fibrillation or Venous Thromboembolism. Drugs Aging. 2025 May;42(5):469-484. doi: 10.1007/s40266-025-01192-7. Epub 2025 Mar 31.

    PubMed 40163217

  • Yamada N, Fu W, Shi Z, Park KH, Kim HS, Dai X, Lensing AW, Pap AF, Kohno T, Tajima T, Watakabe T, Mitsumori T. Risk of recurrent venous thromboembolism and major bleeding according to risk factor profiles in Asian patients: a subgroup analysis EINSTEIN-Extension and EINSTEIN-CHOICE. Thromb J. 2024 Jun 6;22(1):48. doi: 10.1186/s12959-024-00609-4.

    PubMed 38844941

  • Wells PS, Prins MH, Levitan B, Beyer-Westendorf J, Brighton TA, Bounameaux H, Cohen AT, Davidson BL, Prandoni P, Raskob GE, Yuan Z, Katz EG, Gebel M, Lensing AWA. Long-term Anticoagulation With Rivaroxaban for Preventing Recurrent VTE: A Benefit-Risk Analysis of EINSTEIN-Extension. Chest. 2016 Nov;150(5):1059-1068. doi: 10.1016/j.chest.2016.05.023. Epub 2016 Jun 1.

    PubMed 27262225

  • Wells PS, Gebel M, Prins MH, Davidson BL, Lensing AW. Influence of statin use on the incidence of recurrent venous thromboembolism and major bleeding in patients receiving rivaroxaban or standard anticoagulant therapy. Thromb J. 2014 Nov 26;12:26. doi: 10.1186/1477-9560-12-26. eCollection 2014.

    PubMed 25698905

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rivaroxaban (Xarelto, BAY59-7939) in people with Venous Thromboembolism, run by Bayer at 322 sites in 33 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 1 inclusion and 4 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 4 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 322 sites in France, Germany, United States, Australia, China and 28 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment (time frame: 6- or 12-month study treatment period). 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 NCT00439725, which also lists 6 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 4 Nov 2014.

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