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

• ClinicalTrials.gov Identifier: NCT00439725
• Recruitment Status: Completed
• First Posted: February 26, 2007
• Results First Posted: April 12, 2012
• Last Update Posted: November 4, 2014
• Sponsor: Bayer
• Collaborator: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Information provided by (Responsible Party): Bayer

Study Description

Brief 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 trial (Einstein-Extension study).

Condition or disease	Intervention/treatment	Phase
Venous Thromboembolism	Drug: Rivaroxaban (Xarelto, BAY59-7939); Drug: Placebo	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1197 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• 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
• Study Start Date: February 2007
• Actual Primary Completion Date: August 2009
• Actual Study Completion Date: September 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: Rivaroxaban (Xarelto, BAY59-7939); Participants were to receive rivaroxaban 20 mg oral tablet once daily	Drug: Rivaroxaban (Xarelto, BAY59-7939); Patients randomized to rivaroxaban will receive rivaroxaban 20 mg once-daily.
Placebo Comparator: Placebo; Participants were to receive matching placebo oral tablet once daily	Drug: Placebo; Patients allocated to placebo will receive a matching placebo tablet once daily.

Outcome Measures

Primary Outcome Measures :

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 [ Time Frame: 6- or 12-month study treatment period ]
   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.

Secondary Outcome Measures :

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 [ Time Frame: 6- or 12-month study treatment period ]
   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.
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 [ Time Frame: 6- or 12-month study treatment period ]
   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.
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 [ Time Frame: 6- or 12-month study treatment period ]
   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.
4. Percentage of Participants With Recurrent VTE (PE or DVT) Until the Intended End of Study Treatment [ Time Frame: 6- or 12-month study treatment period ]
   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.
5. Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment [ Time Frame: 6- or 12-month study treatment period ]
   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.
6. Percentage of Participants With Major Bleeding [ Time Frame: 6- or 12-month study treatment period ]
   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.
7. Percentage of Participants With Clinically Relevant Bleeding [ Time Frame: 6- or 12-month study treatment period ]
   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
8. Percentage of Participants With All Death [ Time Frame: 6- or 12-month study treatment period ]
   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)
9. Percentage of Participants With Other Vascular Events [ Time Frame: 6- or 12-month study treatment period ]
   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)

Other Outcome Measures:

1. Percentage of Participants With Death (PE) Until the Intended End of Study Treatment [ Time Frame: 6- or 12-month study treatment period ]
   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.
2. Percentage of Participants With Death (PE Cannot be Excluded) Until the Intended End of Study Treatment [ Time Frame: 6- or 12-month study treatment period ]
   All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.
3. Percentage of Participants With Symptomatic Recurrent PE Until the Intended End of Study Treatment [ Time Frame: 6- or 12-month study treatment period ]
   All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either spiral computed tomography (CT) scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, results/films/images of confirmatory testing, and/or case summaries.
4. 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]) During Observational Period [ Time Frame: 30 days observational period after last intake of study medication ]
   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), results/films/images of confirmatory testing, and/or case summaries.
5. Percentage of Participants With Symptomatic Recurrent PE During Observational Period [ Time Frame: 30 days observational period after last intake of study medication ]
   All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either spiral computed tomography (CT) scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, results/films/images of confirmatory testing, and/or case summaries.
6. Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality During Observational Period [ Time Frame: 30 days observational period after last intake of study medication ]
   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 deaths), results/films/images of confirmatory testing, and/or case summaries.
7. Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE, All Cause Mortality, Strokes and Myocardial Infarctions During Observational Period [ Time Frame: 30 days observational period after last intake of study medication ]
   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), results/films/images of confirmatory testing, and/or case summaries.
8. Percentage of Participants With Net Clinical Benefit as Composite of Recurrent DVT or Non-fatal or Fatal PE and Major Bleeding Events During Observational Period [ Time Frame: 30 days observational period after last intake of study medication ]
   Events were adjudicated/confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral CT 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 or more units, occurring in a critical site or contributing to death.
9. Percentage of Participants With Recurrent VTE (PE or DVT) During Observational Period [ Time Frame: 30 days observational period after last intake of study medication ]
   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.
10. Percentage of Participants With Recurrent DVT During Observational Period [ Time Frame: 30 days observational period after last intake of study medication ]
    All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound or venography, results/films/images of confirmatory testing, and/or case summaries.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

United States, Arkansas

Little Rock, Arkansas, United States, 72205

United States, California

Los Angeles, California, United States, 90095

Redlands, California, United States, 92373

United States, Florida

Bay Pines, Florida, United States, 33744

Melbourne, Florida, United States, 32901

Miami, Florida, United States, 33136-1096

Miami, Florida, United States, 33136

United States, Georgia

Decatur, Georgia, United States, 30033

United States, Idaho

Idaho Falls, Idaho, United States, 83404

United States, Louisiana

Covington, Louisiana, United States, 70433

United States, Maryland

Baltimore, Maryland, United States, 21215-5271

United States, Massachusetts

Boston, Massachusetts, United States, 02215

United States, New Mexico

Albuquerque, New Mexico, United States, 87108

United States, North Carolina

Chapel Hill, North Carolina, United States, 27599-7035

Greensboro, North Carolina, United States, 27401

Greensboro, North Carolina, United States, 27403

United States, Oklahoma

Oklahoma City, Oklahoma, United States, 73104

United States, Pennsylvania

Pittsburgh, Pennsylvania, United States, 15224

United States, Texas

Corsicana, Texas, United States, 75110

San Antonio, Texas, United States, 78229

United States, Utah

Murray, Utah, United States, 84107

Salt Lake City, Utah, United States, 84132

United States, Vermont

Burlington, Vermont, United States, 05401

United States, Virginia

Fredericksburg, Virginia, United States, 22401

United States, Washington

Spokane, Washington, United States, 99204

Australia, Australian Capital Territory

Garran, Australian Capital Territory, Australia, 2605

Australia, New South Wales

Gosford, New South Wales, Australia, 2250

Kogarah, New South Wales, Australia, 2217

Lismore, New South Wales, Australia, 2480

St Leonards, New South Wales, Australia, 2065

Sydney, New South Wales, Australia, 2010

Sydney, New South Wales, Australia, 2031

Sydney, New South Wales, Australia, 2139

Sydney, New South Wales, Australia, 2229

Australia, Queensland

Brisbane, Queensland, Australia, 4029

Redcliffe, Queensland, Australia, 4020

Southport, Queensland, Australia, 4215

Woolloongabba, Queensland, Australia, 4102

Australia, South Australia

Adelaide, South Australia, Australia, 5011

Adelaide, South Australia, Australia, 5042

Australia, Victoria

Box Hill, Victoria, Australia, 3128

Clayton, Victoria, Australia, 3168

Geelong, Victoria, Australia, 3220

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Australia, Western Australia

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Perth, Western Australia, Australia, 6000

Austria

Graz, Steiermark, Austria, 8036

Innsbruck, Tirol, Austria, 6020

Feldkirch, Vorarlberg, Austria, 6807

Salzburg, Austria, 5020

Wien, Austria, 1090

Wien, Austria, 1140

Belgium

Bruxelles - Brussel, Belgium, 1070

Bruxelles - Brussel, Belgium, 1200

Duffel, Belgium, 2570

Genk, Belgium, 3600

Gent, Belgium, 9000

Hasselt, Belgium, 3500

Leuven, Belgium, 3000

Liege, Belgium, 4000

Lier, Belgium, 2500

Namur, Belgium, 5000

Sint-Truiden, Belgium, 3800

Yvoir, Belgium, 5530

Zottegem, Belgium, 9620

Brazil

Uberaba, Minas Gerais, Brazil, 38010 380

Curitiba, Parana, Brazil, 80050-350

Londrina, Parana, Brazil, 86038440

Porto Alegre, Rio Grande do Sul, Brazil

Botucatu, Sao Paulo, Brazil, 18618 000

Sorocaba, Sao Paulo, Brazil, 18031-000

São Paulo, Sao Paulo, Brazil, 01323-001

São Paulo, Sao Paulo, Brazil, 01509-900

São Paulo, Sao Paulo, Brazil, 04039-004

Rio de Janeiro, Brazil

Sao Paulo, Brazil, 04023-061

Canada, Manitoba

Winnipeg, Manitoba, Canada, R2H 2A6

Canada, Ontario

Toronto, Ontario, Canada, M6R 1B5

China, Guangdong

Guangzhou, Guangdong, China, 510080

China, Heilongjiang

Harbin, Heilongjiang, China, 150086

China, Hubei

Wuhan, Hubei, China, 430022

China, Jiangsu

Suzhou, Jiangsu, China, 215004

China, Liaoning

Shenyang, Liaoning, China, 110016

China

Beijing, China, 100020

Beijing, China, 100029

Beijing, China, 100037

Beijing, China, 100038

Beijing, China, 100044

Beijing, China, 100730

Beijing, China, 100853

Shanghai, China, 200001

Shanghai, China, 200032

Shanghai, China, 200433

Czech Republic

Brno, Czech Republic, 65691

Karlovy Vary, Czech Republic, 360 00

Kladno, Czech Republic, 27259

Ostrava-Poruba, Czech Republic, 708 52

Ostrava, Czech Republic, 728 80

Prague 5, Czech Republic, 150 00

Praha 1, Czech Republic, 110 00

Praha 2, Czech Republic, 12800

Praha 4, Czech Republic, 140 21

Usti nad Lebem, Czech Republic, 401 13

Denmark

Aarhus C, Denmark, 8000

Braedstrup, Denmark, 8740

Frederiksberg, Denmark, 2000F

Hellerup, Denmark, 2900

Finland

Seinäjoki, Finland, 60220

France

Agen Cedex 9, France, 47923

Amiens, France, 80000

Angers Cedex 01, France, 49033

Arras, France, 62000

Bordeaux, France, 33075

Brest Cedex, France, 29609

Castelnau Le Lez, France, 34170

Clamart, France, 92141

Clermont Ferrand, France, 63000

Colombes, France, 92700

Creteil, France, 94000

Dijon, France, 21000

Grenoble, France, 38028

Grenoble, France, 38043

Lille Cedex, France, 59037

Limoges, France, 87042

Montpellier Cedex, France, 34295

Nantes, France, 44000

Nimes Cedex 9, France, 30029

Orthez, France, 64300

Paris Cedex 15, France, 75908

Paris, France, 75004

Paris, France, 75475

Paris, France, 75877

Pierre Benite, France, 69495

Roanne, France, 42328

Rouen Cedex, France, 76031

Saint Etienne, France, 42055

Strasbourg Cedex, France, 67091

Toulon, France, 83000

Toulouse, France, 31403

Tours, France, 37044

Valenciennes Cedex, France, 59322

Vandoeuvre Les Nancy, France, 54511

Vernon, France, 27200

Germany

Bruchsal, Baden-Württemberg, Germany, 76646

Heidelberg, Baden-Württemberg, Germany, 69115

Karlsbad, Baden-Württemberg, Germany, 76307

Mannheim, Baden-Württemberg, Germany, 68167

Neckargemünd, Baden-Württemberg, Germany, 69151

Tübingen, Baden-Württemberg, Germany, 72076

Augsburg, Bayern, Germany, 86156

München, Bayern, Germany, 80331

München, Bayern, Germany, 81377

Würzburg, Bayern, Germany, 97080

Darmstadt, Hessen, Germany, 64297

Frankfurt, Hessen, Germany, 60596

Gießen, Hessen, Germany, 35392

Wiesbaden, Hessen, Germany, 65183

Greifswald, Mecklenburg-Vorpommern, Germany, 17475

Hannover, Niedersachsen, Germany, 30625

Rotenburg, Niedersachsen, Germany, 27342

Düsseldorf, Nordrhein-Westfalen, Germany, 40225

Essen, Nordrhein-Westfalen, Germany, 45122

Paderborn, Nordrhein-Westfalen, Germany, 33098

Soest, Nordrhein-Westfalen, Germany, 59494

Witten, Nordrhein-Westfalen, Germany, 58455

Mainz, Rheinland-Pfalz, Germany, 55131

Homburg, Saarland, Germany, 66421

Homburg, Saarland, Germany, 66424

Halle, Sachsen-Anhalt, Germany, 06120

Magdeburg, Sachsen-Anhalt, Germany, 39112

Dresden, Sachsen, Germany, 01307

Leipzig, Sachsen, Germany, 04289

Berlin, Germany, 10713

Berlin, Germany, 12099

Hamburg, Germany, 20251

Hong Kong

Hong Kong, Hong Kong

Hungary

Budapest, Hungary, 1096

Budapest, Hungary, 1115

Debrecen, Hungary, 4032

Kecskemet, Hungary, 6000

Kistarcsa, Hungary, 2143

Miskolc, Hungary, 3526

Nyiregyhaza, Hungary, 4400

Szentes, Hungary, 6600

Szombathely, Hungary, 9700

India

Kochi, Kerala, India, 682026

Vellore, Kerala, India, 632004

Mumbai, Maharashtra, India, 400008

Mumbai, Maharashtra, India, 400016

Mumbai, Maharashtra, India, 400022

Hyderabad, India, 500082

Kolkata, India, 700029

New Delhi, India, 110060

Pune, India, 411001

Indonesia

Bandung, Indonesia, 40161

Jakarta, Indonesia, 10430

Medan, Indonesia, 20152

Semarang, Indonesia, 50241

Israel

Afula, Israel, 18101

Ashkelon, Israel, 78278

Beer Sheva, Israel, 84101

Haifa, Israel, 31048

Haifa, Israel, 31096

Haifa, Israel, 34362

Holon, Israel, 58100

Jerusalem, Israel, 91120

Kfar Saba, Israel, 44281

Petach Tikva, Israel, 49100

Rehovot, Israel, 76100

Safed, Israel, 13100

Tel Aviv, Israel, 64239

Italy

Bologna, Italy, 40138

Chieti, Italy, 66013

Milano, Italy, 20132

Milano, Italy, 20142

Napoli, Italy, 80131

Padova, Italy, 35128

Palermo, Italy, 90127

Parma, Italy, 43100

Pavia, Italy, 27100

Piacenza, Italy, 29100

Venezia, Italy, 30122

Korea, Republic of

Daegu, Daegu Gwang'yeogsi, Korea, Republic of, 700721

Seoul, Seoul Teugbyeolsi, Korea, Republic of, 110-744

Daegu, Korea, Republic of, 705-718

Seoul, Korea, Republic of, 120-752

Seoul, Korea, Republic of, 137-701

Taegu, Korea, Republic of, 700-712

Malaysia

Selangor, Malaysia, 68000

Netherlands

Amsterdam, Netherlands, 1105 AZ

Arnhem, Netherlands, 6815 AD

Den Bosch, Netherlands, 5223 GZ

Dordrecht, Netherlands, 3318 AT

Enschede, Netherlands, 7511 JX

Groningen, Netherlands, 9713 GZ

Hoofddorp, Netherlands, 2134 TM

Maastricht, Netherlands, 6229 HX

Rotterdam, Netherlands, 3083 AN

Zwijndrecht, Netherlands, 3331 LZ

Zwolle, Netherlands, 8025 AB

New Zealand

Auckland, New Zealand, 0622

Auckland, New Zealand, 1023

Christchurch, New Zealand, 8011

Palmerston North, New Zealand, 4414

Wellington South, New Zealand, 6021

Norway

Fredrikstad, Norway, 1603

Oslo, Norway, 0407

Oslo, Norway, 0514

Rud, Norway, 1309

Philippines

Quezon City, Philippines, 0850

Quezon City, Philippines, 1102

Poland

Bialystok, Poland, 15-276

Bydgoszcz, Poland, 85-168

Gdansk, Poland, 80-952

Katowice, Poland, 40-365

Krakow, Poland, 31-066

Lodz, Poland, 90-153

Lublin, Poland, 20-081

Poznan, Poland, 60-631

Poznan, Poland, 61-848

Torun, Poland, 87-100

Warszawa, Poland, 01-138

Warszawa, Poland, 02-097

Warszawa, Poland, 04-479

Wroclaw, Poland, 50-326

Wroclaw, Poland, 51-124

Singapore

Singapore, Singapore, 169608

Singapore, Singapore, 308433

South Africa

Cape Town, Cape, South Africa, 7500

Johannesburg, Gauteng, South Africa, 2132

Johannesburg, Gauteng, South Africa, 2157

Johannesburg, Gauteng, South Africa, 2191

Johannesburg, Gauteng, South Africa, 2193

Pretoria, Gauteng, South Africa, 0084

Pretoria, Gauteng, South Africa, 0157

Pretoria, Gauteng, South Africa, 0181

Roodepoort, Gauteng, South Africa, 1724

Cape Town, Western Cape, South Africa, 7460

Somerset West, Western Cape, South Africa, 7130

Worcester, Western Cape, South Africa, 6850

Spain

Terrassa, Barcelona, Spain, 08221

Alcorcón, Madrid, Spain, 28922

Fuenlabrada, Madrid, Spain, 28942

Xàtiva, Valencia, Spain, 46800

Barcelona, Spain, 08025

Barcelona, Spain, 08036

Girona, Spain, 17007

Madrid, Spain, 28034

Pamplona, Spain, 31008

Sweden

Borås, Sweden, 501 82

Göteborg, Sweden, 413 45

Göteborg, Sweden, 416 85

Jönköping, Sweden, 551 85

Sundsvall, Sweden, 851 86

Västervik, Sweden, 593 81

Switzerland

Bruderholz, Basel-Landschaft, Switzerland, 4101

Genéve 14, Genève 14, Switzerland, 1211

Chur, Graubünden, Switzerland, 7000

Brig, Valais, Switzerland, 3900

Lugano, Switzerland, 6903

Luzern, Switzerland, 6000

Zürich, Switzerland, 8091

Taiwan

Kaohsiung, Taiwan, 80756

Tainan, Taiwan, 704

Taipei, Taiwan, 10002

Taipei, Taiwan, 11217

Taoyuan, Taiwan, 333

Thailand

Bangkok, Thailand, 10400

Bangkok, Thailand, 10700

Pathumwan, Bangkok, Thailand, 10330

United Kingdom

Plymouth, Devon, United Kingdom, PL6 8DH

Chelmsford, Essex, United Kingdom, CM1 5ET

Romford, Essex, United Kingdom, RM7 0AG

Isleworth, London, United Kingdom, TW7 6AF

Edinburgh, Lothian, United Kingdom, EH16 4SA

Liverpool, Merseyside, United Kingdom, L7 8XP

London, United Kingdom, SE1 7EH

London, United Kingdom, SE5 9RS

London, United Kingdom, W1T 4EU

London, United Kingdom

Sponsors and Collaborators

Bayer

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Investigators

• Study Director: Bayer Study Director; Bayer

More Information

Additional Information:

Click here to find the definition for Deep Vein Thrombosis [DVT]. 

Click here to find the definition for Pulmonary Embolism [PE]. 

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Publications of Results:

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT00439725
• Other Study ID Numbers: 11899; 2006-004494-96 ( EudraCT Number )
• First Posted: February 26, 2007
• Results First Posted: April 12, 2012
• Last Update Posted: November 4, 2014
• Last Verified: October 2014

Additional relevant MeSH terms:

Pulmonary Embolism; Thrombosis; Embolism; Thromboembolism; Venous Thromboembolism; Venous Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Rivaroxaban; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anticoagulants