Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep Vein Thrombosis - The EINSTEIN DVT Study

January 26, 2014 updated by: Bayer

Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep-Vein Thrombosis or Pulmonary Embolism

This is a multicenter, randomized, open-label, assessor-blind, event-driven, non-inferiority program for efficacy with a study treatment duration of 3, 6 or 12 months in patients with confirmed acute symptomatic DVT without symptomatic PE (Einstein-DVT).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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. Participants who were transferring from study 11702 DVT (NCT00440193) to the extension study 11899 (NCT00439725) did not enter the observational period.

Study Type

Interventional

Enrollment (Actual)

3449

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
      • 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, 2031
      • Sydney, New South Wales, Australia, 2229
      • Sydney, New South Wales, Australia, 2139
    • Queensland
      • Brisbane, Queensland, Australia, 4029
      • Redcliffe, Queensland, Australia, 4020
      • Southport, Queensland, Australia, 4215
      • Woolloongabba, Queensland, Australia, 4102
    • South Australia
      • Adelaide, South Australia, Australia, 5042
      • Woodville South, South Australia, Australia, 5011
    • Victoria
      • Box Hill, Victoria, Australia, 3128
      • Clayton, Victoria, Australia, 3168
      • Geelong, Victoria, Australia, 3220
      • Melbourne, Victoria, Australia, 3135
      • Melbourne, Victoria, Australia, 3181
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
      • Perth, Western Australia, Australia, 6000
  • Austria
      • Innsbruck, Austria, 6020
      • Salzburg, Austria, 5020
      • Wien, Austria, 1090
      • Wien, Austria, 1140
    • Steiermark
      • Graz, Steiermark, Austria, 8036
    • Vorarlberg
      • Feldkirch, Vorarlberg, Austria, 6807
  • 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
      • Yvoir, Belgium, 5530
      • Zottegem, Belgium, 9620
  • Brazil
      • Rio de Janeiro, Brazil
    • Minas Gerais
      • Uberaba, Minas Gerais, Brazil, 38010 380
    • Parana
      • Curitiba, Parana, Brazil, 80050-350
      • Londrina, Parana, Brazil, 86038440
    • SP
      • Sao Paulo, SP, Brazil, 01509-900
      • Sao Paulo, SP, Brazil, 04023-061
      • São Paulo, SP, Brazil, 01323-001
    • Sao Paulo
      • Botucatu, Sao Paulo, Brazil, 18618 000
      • Sorocaba, Sao Paulo, Brazil, 18031-000
      • São Paulo, Sao Paulo, Brazil, 04039-004
  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
    • Ontario
      • London, Ontario, Canada, N6A 4G5
      • Ottawa, Ontario, Canada, K1Y 4E9
      • Toronto, Ontario, Canada, M4N 3M5
      • Toronto, Ontario, Canada, M6R 1B5
  • China
      • Beijing, China, 100044
      • Beijing, China, 100730
      • Beijing, China, 100020
      • Beijing, China, 100029
      • Beijing, China, 100037
      • Beijing, China, 100038
      • Beijing, China, 100853
      • Shanghai, China, 200032
      • Shanghai, China, 200001
      • Shanghai, China, 200433
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
      • Guangzhou, Guangdong, China, 510000
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150086
    • Hubei
      • Wuhan, Hubei, China, 430022
    • Jiangsu
      • Suzhou, Jiangsu, China, 215004
    • Liaoning
      • Shenyang, Liaoning, China, 110016
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
  • Czech Republic
      • Karlovy Vary, Czech Republic, 360 00
      • Kladno, Czech Republic, 27259
      • Ostrava, Czech Republic, 728 80
      • Ostrava-Poruba, Czech Republic, 708 52
      • Prague, Czech Republic, 140 21
      • Prague 5, Czech Republic, 150 00
      • Praha 1, Czech Republic, 110 00
      • Praha 2, Czech Republic, 12800
      • 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
      • Besancon, France, 25000
      • Bordeaux, France, 33000
      • Brest Cedex, France, 29609
      • Castelnau Le Lez, France, 34170
      • Clamart, France, 92141
      • Clermont Ferrand, France, 63000
      • Colombes Cedex, France, 92701
      • Creteil, France, 94000
      • Dijon, France, 21000
      • Grenoble, France, 38043
      • Grenoble, France, 38028
      • Lille Cedex, France, 59037
      • Limoges, France, 87042
      • Metz-tessy, France, 74370
      • Montpellier Cedex, France, 34295
      • Nantes, France, 44000
      • Nice, France, 06002
      • Nimes Cedex 9, France, 30029
      • Orthez, France, 64300
      • Paris, France, 75475
      • Paris, France, 75015
      • Paris, France, 75877
      • Paris, France, 75004
      • Paris Cedex 15, France, 75908
      • 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
      • Berlin, Germany, 10713
      • Berlin, Germany, 12099
      • Hamburg, Germany, 20251
    • Baden-Württemberg
      • 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
    • Bayern
      • Augsburg, Bayern, Germany, 86156
      • München, Bayern, Germany, 81377
      • München, Bayern, Germany, 80331
      • Würzburg, Bayern, Germany, 97080
    • Hessen
      • Darmstadt, Hessen, Germany, 64297
      • Frankfurt, Hessen, Germany, 60590
      • Frankfurt, Hessen, Germany, 60596
      • Gießen, Hessen, Germany, 35392
      • Wiesbaden, Hessen, Germany, 65183
    • Mecklenburg-Vorpommern
      • Greifswald, Mecklenburg-Vorpommern, Germany, 17475
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
      • Rotenburg, Niedersachsen, Germany, 27342
    • Nordrhein-Westfalen
      • 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
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55131
    • Saarland
      • Homburg, Saarland, Germany, 66424
      • Homburg, Saarland, Germany, 66421
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
      • Leipzig, Sachsen, Germany, 04289
    • Sachsen-Anhalt
      • Halle, Sachsen-Anhalt, Germany, 06120
      • Magdeburg, Sachsen-Anhalt, Germany, 39112
  • Hong Kong
      • Hong Kong, Hong Kong
      • Wanchai, Hong Kong
  • Hungary
      • Budapest, Hungary, 1115
      • Budapest, Hungary, 1096
      • Debrecen, Hungary, 4032
      • Kecskemet, Hungary, 6000
      • Kistarcsa, Hungary, 2143
      • Miskolc, Hungary, 3526
      • Szentes, Hungary, 6600
      • Szombathely, Hungary, 9700
  • India
      • Hyderabad, India, 500082
      • Kolkata, India, 700029
      • New Delhi, India, 110060
      • Pune, India, 411001
    • Kerala
      • Kochi, Kerala, India, 682026
    • Maharashtra
      • Mumbai, Maharashtra, India, 400016
  • Indonesia
      • Bandung, Indonesia, 40161
      • Jakarta, Indonesia, 10430
      • Jakarta, Indonesia, 10330
      • Medan, Indonesia, 20152
      • Semarang, Indonesia, 50241
  • Israel
      • Afula, Israel, 18101
      • Ashkelon, Israel, 78306
      • Beer Sheva, Israel, 84101
      • Haifa, Israel, 31048
      • Haifa, Israel, 34362
      • Haifa, Israel, 31096
      • 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
      • Cremona, Italy, 26100
      • Milano, Italy, 20122
      • Milano, Italy, 20132
      • Milano, Italy, 20142
      • Napoli, Italy, 80131
      • Padova, Italy, 35128
      • Palermo, Italy, 90127
      • Parma, Italy, 43100
      • Pavia, Italy, 27100
      • Piacenza, Italy, 29100
      • Reggio Emilia, Italy, 42100
      • Varese, Italy, 21100
      • Venezia, Italy, 30122
  • Korea, Republic of
      • Daegu, Korea, Republic of, 705-718
      • Daegu, Korea, Republic of, 700721
      • Seoul, Korea, Republic of, 137-701
      • Seoul, Korea, Republic of, 120-752
      • Taegu, Korea, Republic of, 700-712
    • Korea
      • Seoul, Korea, Korea, Republic of, 110-744
  • Malaysia
      • Selangor, Malaysia, 68000
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
      • Arnhem, Netherlands, 6815 AD
      • 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, 1023
      • Auckland, New Zealand, 2024
      • Auckland, New Zealand, 0622
      • Christchurch, New Zealand, 8011
      • Palmerston North, New Zealand, 4414
      • Wellington South, New Zealand, 6021
  • Norway
      • Fredrikstad, Norway, 1603
      • Oslo, Norway, 0407
      • Rud, Norway, 1309
      • Trondheim, Norway, 7006
  • Philippines
      • Quezon City, Philippines, 1102
      • Quezon City, Philippines, 0850
  • 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, 51-124
      • Wroclaw, Poland, 50-326
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
  • Singapore
      • Singapore, Singapore, 169608
      • Singapore, Singapore, 308433
  • South Africa
    • Cape
      • Cape Town, Cape, South Africa, 7500
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2132
      • Johannesburg, Gauteng, South Africa, 2191
      • Johannesburg, Gauteng, South Africa, 2193
      • Johannesburg, Gauteng, South Africa, 2157
      • Johannesburg, Gauteng, South Africa, 1724
      • Pretoria, Gauteng, South Africa, 0181
      • Pretoria, Gauteng, South Africa, 0084
      • Pretoria, Gauteng, South Africa, 0157
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7460
      • Somerset West, Western Cape, South Africa, 7130
      • Worcester, Western Cape, South Africa, 6850
  • Spain
      • Barcelona, Spain, 08036
      • Barcelona, Spain, 08025
      • Girona, Spain, 17007
      • Madrid, Spain, 28034
      • Pamplona, Spain, 31008
    • Barcelona
      • Terrassa, Barcelona, Spain, 08221
    • Madrid
      • Alcorcón, Madrid, Spain, 28922
      • Fuenlabrada, Madrid, Spain, 28942
    • Valencia
      • Xàtiva, Valencia, Spain, 46800
  • Sweden
      • Borås, Sweden, 501 82
      • Göteborg, Sweden, 416 85
      • Göteborg, Sweden, 413 45
      • Jönköping, Sweden, 551 85
      • Sundsvall, Sweden, 851 86
      • Västervik, Sweden, 593 81
  • Switzerland
      • Luzern, Switzerland, 6000
      • Zürich, Switzerland, 8091
    • Genève 14
      • Genéve 14, Genève 14, Switzerland, 1211
    • Graubünden
      • Chur, Graubünden, Switzerland, 7000
    • Waadt
      • Lausanne, Waadt, Switzerland, 1005
      • Lausanne, Waadt, Switzerland, 1011
  • Taiwan
      • Taichung, Taiwan, 40705
      • Taipei, Taiwan, 112
      • Taipei, Taiwan, 10016
      • Taipei, Taiwan, 220
    • Kaoshiong
      • Kaosiung, Kaoshiong, Taiwan, 807
  • Thailand
      • Bangkok, Thailand, 10400
      • Bangkok, Thailand, 10700
      • Pathumwan, Bangkok, Thailand, 10330
  • United Kingdom
      • London, United Kingdom
    • Devon
      • Plymouth, Devon, United Kingdom, PL6 8DH
    • Essex
      • Chelmsford, Essex, United Kingdom, CM1 5ET
    • Greater London
      • Isleworth, Greater London, United Kingdom, TW7 6AF
      • London, Greater London, United Kingdom, SE5 9RS
      • London, Greater London, United Kingdom, SE1 7EH
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
    • California
      • Redlands, California, United States, 92373
    • Florida
      • Bay Pines, Florida, United States, 33744
      • Miami, Florida, United States, 33136
      • Miami, Florida, United States, 33136-1096
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
    • Louisiana
      • Covington, Louisiana, United States, 70433
    • Maryland
      • Baltimore, Maryland, United States, 21215
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108-4763
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7035
      • Greensboro, North Carolina, United States, 27401
      • Greensboro, North Carolina, United States, 27403
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
      • Pittsburgh, Pennsylvania, United States, 15224
    • Texas
      • Corsicana, Texas, United States, 75110
      • San Antonio, Texas, United States, 78229
    • Utah
      • Murray, Utah, United States, 84157
      • Salt Lake City, Utah, United States, 84132
    • Virginia
      • Fredericksburg, Virginia, United States, 22401
    • Washington
      • Spokane, Washington, United States, 99204
      • Tacoma, Washington, United States, 98405

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Confirmed acute symptomatic proximal DVT without symptomatic PE

Exclusion Criteria:

  • Legal lower age limitations (country specific)
  • Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT and/or PE
  • Other indication for VKA than DVT and/or PE
  • The pre-randomization anti-coagulant treatment (Criteria # 4) has been prolonged from 36 hours to a maximum of 48 hours.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rivaroxaban (Xarelto, BAY59-7939)
Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
Drug: Rivaroxaban (Xarelto, BAY59-7939)
During the first 3 weeks patients will receive 15 mg rivaroxaban twice-daily. Thereafter, patients will receive rivaroxaban 20 mg once-daily. Rivaroxaban will be administered orally and should be taken with food.
Active Comparator: Enoxaparin/VKA
Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
Drug: Enoxaparin followed by VKA
Enoxaparin 1.0 mg/kg twice daily with a minimal duration of 5 days. This 5 days treatment could include the period up to 36 h before randomization if enoxaparin twice-daily was used. VKA should be started as soon as possible but not later than 48 hours after randomization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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: 3-, 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.
3-, 6- or 12-month study treatment period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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: 3-, 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 deaths), results/films/images of confirmatory testing, and/or case summaries.
3-, 6- or 12-month study treatment period
Percentage of Participants With an Event for Net Clinical Benefit 1 Until the Intended End of Study Treatment
Time Frame: 3-, 6- or 12-month study treatment period
Net clinical benefit 1: composite of recurrent DVT or non-fatal or fatal PE, and major bleeding. 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. Net clinical benefit was considered greater in those participants with fewer composite events. 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.
3-, 6- or 12-month study treatment period
Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment
Time Frame: 3-, 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.
3-, 6- or 12-month study treatment period
Percentage of Participants With Clinically Relevant Bleeding, Treatment-emergent (Time Window: Until 2 Days After Last Dose)
Time Frame: 3-, 6- or 12-month study treatment period
All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Clinically relevant bleeding included major bleeding (overt bleeding associated with 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) 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 activities of daily life.
3-, 6- or 12-month study treatment period
Percentage of Participants With All Deaths
Time Frame: 3-, 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.
3-, 6- or 12-month study treatment period
Percentage of Participants With Other Vascular Events, On-treatment (Time Window: Until 1 Day After Last Dose)
Time Frame: 3-, 6- or 12-month study treatment period
All pre-defined vascular events (ST segment elevation myocardial infarction, non ST segment elevation myocardial infarction, unstable angina, ischemic stroke, transient ischemic attack, non-central nervous system systemic embolism or vascular death) were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based results/films/images of confirmatory testing, and/or case summaries.
3-, 6- or 12-month study treatment period

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With the Individual Components of Efficacy Outcomes Until the Intended End of Study Treatment
Time Frame: 3-, 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.
3-, 6- or 12-month study treatment period
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: Up to 30 days after the 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.
Up to 30 days after the last intake of study medication
Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality During Observational Period
Time Frame: Up to 30 days after the 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.
Up to 30 days after the last intake of study medication
Percentage of Participants With an Event for Net Clinical Benefit 1 During Observational Period
Time Frame: Up to 30 days after the last intake of study medication
Net clinical benefit 1: composite of recurrent DVT or non-fatal or fatal PE or major bleeding. 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. Net clinical benefit was considered greater in those participants with fewer composite events. 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.
Up to 30 days after the last intake of study medication
Percentage of Participants With Recurrent DVT During Observational Period
Time Frame: Up to 30 days after the 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, venography, results/films/images of confirmatory testing, and/or case summaries.
Up to 30 days after the last intake of study medication
Percentage of Participants With the Individual Components of Efficacy Outcomes During Observational Period
Time Frame: Up to 30 days after the last intake of study medication
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.
Up to 30 days after the last intake of study medication

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

February 23, 2007

First Submitted That Met QC Criteria

February 23, 2007

First Posted (Estimate)

February 26, 2007

Study Record Updates

Last Update Posted (Estimate)

February 27, 2014

Last Update Submitted That Met QC Criteria

January 26, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11702a
  • 2006-004495-13 (EudraCT Number)
  • 11702b (Company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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