Efficacy and Safety of Dabigatran Compared to Warfarin for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism (RE-COVER I)

A Phase III, Randomised, Double Blind, Parallel-group Study of the Efficacy and Safety of Oral Dabigatran Etexilate 150 mg Twice Daily Compared to Warfarin (INR 2.0-3.0) for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism (VTE), Following Initial Treatment (5-10 Days) With a Parenteral Anticoagulant Approved for This Indication.

The purpose of this trial is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin as needed (pro re nata - prn) to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic venous thromboembolism (VTE), following initial treatment (5-10 days) with a parenteral anticoagulant approved for this indication. This trial aims to demonstrate non-inferiority of dabigatran compared with warfarin in patients with acute symptomatic VTE. After achieving non-inferiority, this trial also aims to establish superiority (by means of hierarchical tests) of dabigatran over warfarin.

Study Overview

• Status: Completed
• Conditions: Thromboembolism
• Intervention / Treatment: Drug: dabigatran etexilate 150 mg; Drug: warfarin (INR 2-3)

• Study Type: Interventional
• Enrollment (Actual): 2564
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Adrogué, Argentina
    • 1160.53.54017 Boehringer Ingelheim Investigational Site
  • Capital Federal, Argentina
    • 1160.53.54003 Boehringer Ingelheim Investigational Site
  • Capital Federal, Argentina
    • 1160.53.54005 Boehringer Ingelheim Investigational Site
  • Capital Federal, Argentina
    • 1160.53.54006 Boehringer Ingelheim Investigational Site
  • Capital Federal, Argentina
    • 1160.53.54007 Boehringer Ingelheim Investigational Site
  • Capital Federal, Argentina
    • 1160.53.54010 Boehringer Ingelheim Investigational Site
• Australia
  • Queensland
    • Woolloongabba, Queensland, Australia
      • 1160.53.61002 Boehringer Ingelheim Investigational Site
  • South Australia
    • Bedford Park, South Australia, Australia
      • 1160.53.61004 Boehringer Ingelheim Investigational Site
  • Victoria
    • Box Hill, Victoria, Australia
      • 1160.53.61003 Boehringer Ingelheim Investigational Site
    • Clayton, Victoria, Australia
      • 1160.53.61001 Boehringer Ingelheim Investigational Site
    • Windsor, Victoria, Australia
      • 1160.53.61006 The Avenue Cardiovascular Centre
  • Western Australia
    • Perth, Western Australia, Australia
      • 1160.53.61005 Boehringer Ingelheim Investigational Site
• Austria
  • Graz, Austria
    • 1160.53.43001 Boehringer Ingelheim Investigational Site
  • Innsbruck, Austria
    • 1160.53.43003 Boehringer Ingelheim Investigational Site
  • Wien, Austria
    • 1160.53.43002 Boehringer Ingelheim Investigational Site
• Belgium
  • Brussel, Belgium
    • 1160.53.32003 Boehringer Ingelheim Investigational Site
  • Bruxelles, Belgium
    • 1160.53.32001 Boehringer Ingelheim Investigational Site
  • Bruxelles, Belgium
    • 1160.53.32002 Boehringer Ingelheim Investigational Site
  • Edegem, Belgium
    • 1160.53.32007 Boehringer Ingelheim Investigational Site
  • Leuven, Belgium
    • 1160.53.32005 Boehringer Ingelheim Investigational Site
  • Liège, Belgium
    • 1160.53.32004 Boehringer Ingelheim Investigational Site
• Brazil
  • Brasília, Brazil
    • 1160.53.55010 Boehringer Ingelheim Investigational Site
  • Campinas, Brazil
    • 1160.53.55007 Boehringer Ingelheim Investigational Site
  • Cerqueira César - Sao Paulo, Brazil
    • 1160.53.55001 Boehringer Ingelheim Investigational Site
  • Cerqueira César - São Paulo, Brazil
    • 1160.53.55002 Boehringer Ingelheim Investigational Site
  • Cristo Rei - Curitiba, Brazil
    • 1160.53.55014 Boehringer Ingelheim Investigational Site
  • Goiânia -, Brazil
    • 1160.53.55011 Boehringer Ingelheim Investigational Site
  • Paraná -, Brazil
    • 1160.53.55017 Boehringer Ingelheim Investigational Site
  • Porto Alegre, Brazil
    • 1160.53.55012 Boehringer Ingelheim Investigational Site
  • Rio de Janeiro - RJ, Brazil
    • 1160.53.55016 Boehringer Ingelheim Investigational Site
  • Santo André, Brazil
    • 1160.53.55004 Boehringer Ingelheim Investigational Site
  • São José do Rio Preto, Brazil
    • 1160.53.55005 Boehringer Ingelheim Investigational Site
• Canada
  • Quebec, Canada
    • 1160.53.02020 Boehringer Ingelheim Investigational Site
  • Alberta
    • Edmonton, Alberta, Canada
      • 1160.53.02006 Boehringer Ingelheim Investigational Site
    • Edmonton, Alberta, Canada
      • 1160.53.02013 Boehringer Ingelheim Investigational Site
  • British Columbia
    • Victoria, British Columbia, Canada
      • 1160.53.02021 Boehringer Ingelheim Investigational Site
  • New Brunswick
    • Saint Johns, New Brunswick, Canada
      • 1160.53.02004 Boehringer Ingelheim Investigational Site
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
      • 1160.53.02001 Boehringer Ingelheim Investigational Site
  • Ontario
    • Hamilton, Ontario, Canada
      • 1160.53.02002 Boehringer Ingelheim Investigational Site
    • Hamilton, Ontario, Canada
      • 1160.53.02005 Boehringer Ingelheim Investigational Site
    • Hamilton, Ontario, Canada
      • 1160.53.02010 Boehringer Ingelheim Investigational Site
    • Hamilton, Ontario, Canada
      • 1160.53.02022 Boehringer Ingelheim Investigational Site
    • London, Ontario, Canada
      • 1160.53.02011 Boehringer Ingelheim Investigational Site
    • Ottawa, Ontario, Canada
      • 1160.53.02015 Boehringer Ingelheim Investigational Site
    • Toronto, Ontario, Canada
      • 1160.53.02019 Boehringer Ingelheim Investigational Site
  • Quebec
    • Montreal, Quebec, Canada
      • 1160.53.02008 Boehringer Ingelheim Investigational Site
    • Montreal, Quebec, Canada
      • 1160.53.02009 Boehringer Ingelheim Investigational Site
    • Montreal, Quebec, Canada
      • 1160.53.02014 Boehringer Ingelheim Investigational Site
    • Montreal, Quebec, Canada
      • 1160.53.02017 Boehringer Ingelheim Investigational Site
    • Sainte-Foy, Quebec, Canada
      • 1160.53.02003 Boehringer Ingelheim Investigational Site
• Czech Republic
  • Brno, Czech Republic
    • 1160.53.42001 Boehringer Ingelheim Investigational Site
  • Hradec Kralove, Czech Republic
    • 1160.53.42002 Boehringer Ingelheim Investigational Site
  • Hranice, Czech Republic
    • 1160.53.42011 Boehringer Ingelheim Investigational Site
  • Jihlava, Czech Republic
    • 1160.53.42009 Boehringer Ingelheim Investigational Site
  • Liberec, Czech Republic
    • 1160.53.42012 Boehringer Ingelheim Investigational Site
  • Novy Jicin, Czech Republic
    • 1160.53.42015 Boehringer Ingelheim Investigational Site
  • Ostrava-Vitkovice, Czech Republic
    • 1160.53.42005 Boehringer Ingelheim Investigational Site
  • Praha 2, Czech Republic
    • 1160.53.42004 Boehringer Ingelheim Investigational Site
  • Tabor, Czech Republic
    • 1160.53.42014 Boehringer Ingelheim Investigational Site
  • Teplice, Czech Republic
    • 1160.53.42016 Boehringer Ingelheim Investigational Site
  • Usti nad Labem, Czech Republic
    • 1160.53.42010 Boehringer Ingelheim Investigational Site
  • Zlin, Czech Republic
    • 1160.53.42007 Boehringer Ingelheim Investigational Site
• Denmark
  • Esbjerg, Denmark
    • 1160.53.45008 Boehringer Ingelheim Investigational Site
  • Holbæk, Denmark
    • 1160.53.45009 Boehringer Ingelheim Investigational Site
  • Kolding, Denmark
    • 1160.53.45002 Boehringer Ingelheim Investigational Site
  • København NV, Denmark
    • 1160.53.45004 Boehringer Ingelheim Investigational Site
  • København S, Denmark
    • 1160.53.45007 Boehringer Ingelheim Investigational Site
  • Slagelse, Denmark
    • 1160.53.45006 Boehringer Ingelheim Investigational Site
• France
  • Brest Cedex, France
    • 1160.53.3301A Boehringer Ingelheim Investigational Site
  • Brest Cedex, France
    • 1160.53.3301B Boehringer Ingelheim Investigational Site
  • Brest Cedex, France
    • 1160.53.3301C Boehringer Ingelheim Investigational Site
  • Brest Cedex, France
    • 1160.53.3301D Boehringer Ingelheim Investigational Site
  • Brest Cedex, France
    • 1160.53.3301E Boehringer Ingelheim Investigational Site
  • Brest Cedex, France
    • 1160.53.3301F Boehringer Ingelheim Investigational Site
  • Brest Cedex, France
    • 1160.53.3301H Boehringer Ingelheim Investigational Site
  • Brest Cedex, France
    • 1160.53.3301I Boehringer Ingelheim Investigational Site
  • Lorient, France
    • 1160.53.3302A Boehringer Ingelheim Investigational Site
  • Montpellier Cedex 5, France
    • 1160.53.3310A Boehringer Ingelheim Investigational Site
  • Montpellier Cedex 5, France
    • 1160.53.3310B Boehringer Ingelheim Investigational Site
  • Montpellier Cedex 5, France
    • 1160.53.3310C Boehringer Ingelheim Investigational Site
  • Nancy, France
    • 1160.53.3308B Boehringer Ingelheim Investigational Site
  • St Etienne Cedex 2, France
    • 1160.53.3303B Boehringer Ingelheim Investigational Site
  • St Etienne Cedex 2, France
    • 1160.53.3303C Boehringer Ingelheim Investigational Site
  • St Etienne Cedex 2, France
    • 1160.53.3303D Boehringer Ingelheim Investigational Site
  • St Etienne Cedex 2, France
    • 1160.53.3303E Boehringer Ingelheim Investigational Site
  • St Priest en Jarez, France
    • 1160.53.3303A Boehringer Ingelheim Investigational Site
  • Toulon Naval, France
    • 1160.53.3311A Boehringer Ingelheim Investigational Site
  • Toulon Naval, France
    • 1160.53.3311B Boehringer Ingelheim Investigational Site
  • Toulon Naval, France
    • 1160.53.3311C Boehringer Ingelheim Investigational Site
  • Toulon Naval, France
    • 1160.53.3311D Boehringer Ingelheim Investigational Site
  • Toulon Naval, France
    • 1160.53.3311E Boehringer Ingelheim Investigational Site
  • Vandoeuvre les Nancy, France
    • 1160.53.3308A Boehringer Ingelheim Investigational Site
• Germany
  • Dresden, Germany
    • 1160.53.49017 Boehringer Ingelheim Investigational Site
  • Dresden, Germany
    • 1160.53.49018 Boehringer Ingelheim Investigational Site
  • Köln, Germany
    • 1160.53.49003 Boehringer Ingelheim Investigational Site
  • Mannheim, Germany
    • 1160.53.49005 Boehringer Ingelheim Investigational Site
  • München, Germany
    • 1160.53.49007 Boehringer Ingelheim Investigational Site
  • Püttlingen, Germany
    • 1160.53.49009 Boehringer Ingelheim Investigational Site
• Greece
  • Athens, Greece
    • 1160.53.30001 Boehringer Ingelheim Investigational Site
  • Athens, Greece
    • 1160.53.30005 Boehringer Ingelheim Investigational Site
  • Athens, Greece
    • 1160.53.30006 Boehringer Ingelheim Investigational Site
• Hungary
  • Budapest, Hungary
    • 1160.53.36001 Boehringer Ingelheim Investigational Site
  • Budapest, Hungary
    • 1160.53.36006 Boehringer Ingelheim Investigational Site
  • Debrecen, Hungary
    • 1160.53.36002 Boehringer Ingelheim Investigational Site
  • Eger, Hungary
    • 1160.53.36013 Boehringer Ingelheim Investigational Site
  • Gyula, Hungary
    • 1160.53.36012 Boehringer Ingelheim Investigational Site
  • Miskolc, Hungary
    • 1160.53.36004 Boehringer Ingelheim Investigational Site
  • Pecs, Hungary
    • 1160.53.36003 Boehringer Ingelheim Investigational Site
  • Szombathely, Hungary
    • 1160.53.36011 Boehringer Ingelheim Investigational Site
  • Székesfehérvár, Hungary
    • 1160.53.36010 Boehringer Ingelheim Investigational Site
• India
  • Bangalore, India
    • 1160.53.91011 Boehringer Ingelheim Investigational Site
  • Chennai, India
    • 1160.53.91012 Boehringer Ingelheim Investigational Site
  • Chennai, India
    • 1160.53.91019 Boehringer Ingelheim Investigational Site
  • Indore, India
    • 1160.53.91013 Boehringer Ingelheim Investigational Site
  • Karna, India
    • 1160.53.91021 Boehringer Ingelheim Investigational Site
  • Kerala, India
    • 1160.53.91022 Boehringer Ingelheim Investigational Site
  • Ludhiana, India
    • 1160.53.91020 Boehringer Ingelheim Investigational Site
  • Mysore, India
    • 1160.53.91007 Boehringer Ingelheim Investigational Site
  • Nagpur, India
    • 1160.53.91015 Boehringer Ingelheim Investigational Site
  • New Delhi, India
    • 1160.53.91010 Boehringer Ingelheim Investigational Site
  • Pune, India
    • 1160.53.91005 Boehringer Ingelheim Investigational Site
  • Pune, India
    • 1160.53.91008 Boehringer Ingelheim Investigational Site
  • Vadodara, India
    • 1160.53.91004 Boehringer Ingelheim Investigational Site
• Israel
  • Afula, Israel
    • 1160.53.97202 Boehringer Ingelheim Investigational Site
  • Ashkelon, Israel
    • 1160.53.97207 Boehringer Ingelheim Investigational Site
  • Haifa, Israel
    • 1160.53.97211 Boehringer Ingelheim Investigational Site
  • Holon, Israel
    • 1160.53.97203 Boehringer Ingelheim Investigational Site
  • KfarSaba, Israel
    • 1160.53.97205 Boehringer Ingelheim Investigational Site
  • Petah Tiqwa, Israel
    • 1160.53.97206 Boehringer Ingelheim Investigational Site
  • Tel Hashomer, Israel
    • 1160.53.97204 Boehringer Ingelheim Investigational Site
  • Tel-Aviv, Israel
    • 1160.53.97210 Boehringer Ingelheim Investigational Site
  • Zerifin, Israel
    • 1160.53.97201 Boehringer Ingelheim Investigational Site
• Italy
  • Bologna, Italy
    • 1160.53.39003 Boehringer Ingelheim Investigational Site
  • Padova, Italy
    • 1160.53.39002 Boehringer Ingelheim Investigational Site
  • Perugia, Italy
    • 1160.53.39001 Boehringer Ingelheim Investigational Site
  • Reggio Emilia, Italy
    • 1160.53.39004 Boehringer Ingelheim Investigational Site
  • Vimercate, Italy
    • 1160.53.39007 Boehringer Ingelheim Investigational Site
  • Vittorio Veneto (tv), Italy
    • 1160.53.39005 Boehringer Ingelheim Investigational Site
• Mexico
  • Chihuahua, Mexico
    • 1160.53.5264 Boehringer Ingelheim Investigational Site
  • Culiacan, Mexico
    • 1160.53.5270 Boehringer Ingelheim Investigational Site
  • San Luis Potosí, Mexico
    • 1160.53.5262 Boehringer Ingelheim Investigational Site
• Netherlands
  • 's Hertogenbosch, Netherlands
    • 1160.53.31010 Boehringer Ingelheim Investigational Site
  • Amersfoort, Netherlands
    • 1160.53.31001 Boehringer Ingelheim Investigational Site
  • Amsterdam, Netherlands
    • 1160.53.31006 Boehringer Ingelheim Investigational Site
  • Eindhoven, Netherlands
    • 1160.53.31013 Boehringer Ingelheim Investigational Site
  • Maastricht, Netherlands
    • 1160.53.31005 Boehringer Ingelheim Investigational Site
  • Nieuwegein, Netherlands
    • 1160.53.31002 Boehringer Ingelheim Investigational Site
  • Rotterdam, Netherlands
    • 1160.53.31004 Boehringer Ingelheim Investigational Site
  • Rotterdam, Netherlands
    • 1160.53.31009 Boehringer Ingelheim Investigational Site
• New Zealand
  • Auckland, New Zealand
    • 1160.53.64003 Boehringer Ingelheim Investigational Site
  • Christchurch, New Zealand
    • 1160.53.64004 Boehringer Ingelheim Investigational Site
  • Otahuhu Auckland, New Zealand
    • 1160.53.64002 Boehringer Ingelheim Investigational Site
  • Takapuna Auckland, New Zealand
    • 1160.53.64001 Boehringer Ingelheim Investigational Site
• Norway
  • Oslo, Norway
    • 1160.53.47001 Boehringer Ingelheim Investigational Site
  • Oslo, Norway
    • 1160.53.47004 Boehringer Ingelheim Investigational Site
  • Rud, Norway
    • 1160.53.47003 Boehringer Ingelheim Investigational Site
  • Trondheim, Norway
    • 1160.53.47005 Boehringer Ingelheim Investigational Site
• Portugal
  • Almada, Portugal
    • 1160.53.35104 Boehringer Ingelheim Investigational Site
  • Coimbra, Portugal
    • 1160.53.35109 Boehringer Ingelheim Investigational Site
  • Lisboa, Portugal
    • 1160.53.35101 Boehringer Ingelheim Investigational Site
  • Lisboa, Portugal
    • 1160.53.35102 Boehringer Ingelheim Investigational Site
  • Lisboa, Portugal
    • 1160.53.35105 Boehringer Ingelheim Investigational Site
• Russian Federation
  • Chelyabinsk, Russian Federation
    • 1160.53.07011 Boehringer Ingelheim Investigational Site
  • Chelyabinsk, Russian Federation
    • 1160.53.07021 Boehringer Ingelheim Investigational Site
  • Ekaterinburg, Russian Federation
    • 1160.53.07007 Boehringer Ingelheim Investigational Site
  • Krasnodar, Russian Federation
    • 1160.53.07016 Boehringer Ingelheim Investigational Site
  • Kursk, Russian Federation
    • 1160.53.07004 Boehringer Ingelheim Investigational Site
  • Moscow, Russian Federation
    • 1160.53.07003 Boehringer Ingelheim Investigational Site
  • Novosibirsk, Russian Federation
    • 1160.53.07010 Boehringer Ingelheim Investigational Site
  • Omsk, Russian Federation
    • 1160.53.07020 Boehringer Ingelheim Investigational Site
  • Pskov, Russian Federation
    • 1160.53.07018 Boehringer Ingelheim Investigational Site
  • Rostov-na-Donu, Russian Federation
    • 1160.53.07009 Boehringer Ingelheim Investigational Site
  • Rostov-na-Donu, Russian Federation
    • 1160.53.07023 Boehringer Ingelheim Investigational Site
  • Rostov-na-Donu, Russian Federation
    • 1160.53.07024 Boehringer Ingelheim Investigational Site
  • Rostov-na-Donu, Russian Federation
    • 1160.53.07025 Boehringer Ingelheim Investigational Site
  • St. Petersburg, Russian Federation
    • 1160.53.07001 Boehringer Ingelheim Investigational Site
  • Ufa, Russian Federation
    • 1160.53.07014 Boehringer Ingelheim Investigational Site
  • Yaroslavl, Russian Federation
    • 1160.53.07005 Boehringer Ingelheim Investigational Site
  • Yaroslavl, Russian Federation
    • 1160.53.07006 Boehringer Ingelheim Investigational Site
• Slovakia
  • Banska Bystrica, Slovakia
    • 1160.53.42107 Boehringer Ingelheim Investigational Site
  • Lucenec, Slovakia
    • 1160.53.42106 Boehringer Ingelheim Investigational Site
  • Nitra, Slovakia
    • 1160.53.42102 Boehringer Ingelheim Investigational Site
  • Nove Zamky, Slovakia
    • 1160.53.42103 Boehringer Ingelheim Investigational Site
  • Zilina, Slovakia
    • 1160.53.42104 Boehringer Ingelheim Investigational Site
• South Africa
  • Centurion, South Africa
    • 1160.53.27007 Boehringer Ingelheim Investigational Site
  • Johannesburg, South Africa
    • 1160.53.27001 Boehringer Ingelheim Investigational Site
  • Johannesburg, South Africa
    • 1160.53.27002 Boehringer Ingelheim Investigational Site
  • Johannesburg, South Africa
    • 1160.53.27004 Boehringer Ingelheim Investigational Site
  • Johannesburg, South Africa
    • 1160.53.27006 Boehringer Ingelheim Investigational Site
  • Pretoria, South Africa
    • 1160.53.27009 Suite 404, Medical Centre
  • Randburg, South Africa
    • 1160.53.27003 Boehringer Ingelheim Investigational Site
  • Richards Bay, South Africa
    • 1160.53.27008 Suite M5, Second Floor
  • Roodepoort, South Africa
    • 1160.53.27005 Boehringer Ingelheim Investigational Site
• Spain
  • Badalona (Barcelona), Spain
    • 1160.53.34012 Boehringer Ingelheim Investigational Site
  • Barcelona, Spain
    • 1160.53.34001 Boehringer Ingelheim Investigational Site
  • Barcelona, Spain
    • 1160.53.34002 Boehringer Ingelheim Investigational Site
  • Cartagena. Murcia, Spain
    • 1160.53.34007 Boehringer Ingelheim Investigational Site
  • Cuenca, Spain
    • 1160.53.34003 Boehringer Ingelheim Investigational Site
  • Madrid, Spain
    • 1160.53.34009 Boehringer Ingelheim Investigational Site
  • Madrid, Spain
    • 1160.53.34010 Boehringer Ingelheim Investigational Site
  • Santander, Spain
    • 1160.53.34004 Boehringer Ingelheim Investigational Site
  • Torrelavega.Santander, Spain
    • 1160.53.34005 Boehringer Ingelheim Investigational Site
  • Valencia, Spain
    • 1160.53.34011 Boehringer Ingelheim Investigational Site
• Sweden
  • Göteborg, Sweden
    • 1160.53.46002 Boehringer Ingelheim Investigational Site
  • Jönköping, Sweden
    • 1160.53.46006 Boehringer Ingelheim Investigational Site
  • Stockholm, Sweden
    • 1160.53.46001 Boehringer Ingelheim Investigational Site
  • Stockholm, Sweden
    • 1160.53.46007 Boehringer Ingelheim Investigational Site
  • Stockholm, Sweden
    • 1160.53.46008 Boehringer Ingelheim Investigational Site
  • Sundsvall, Sweden
    • 1160.53.46005 Boehringer Ingelheim Investigational Site
  • Uppsala, Sweden
    • 1160.53.46003 Boehringer Ingelheim Investigational Site
• Turkey
  • Ankara, Turkey
    • 1160.53.90003 Boehringer Ingelheim Investigational Site
  • Ankara, Turkey
    • 1160.53.90004 Boehringer Ingelheim Investigational Site
  • Ankara, Turkey
    • 1160.53.90005 Boehringer Ingelheim Investigational Site
  • Istanbul, Turkey
    • 1160.53.90001 Boehringer Ingelheim Investigational Site
  • Istanbul, Turkey
    • 1160.53.90002 Boehringer Ingelheim Investigational Site
  • Istanbul, Turkey
    • 1160.53.90007 Boehringer Ingelheim Investigational Site
  • Izmir, Turkey
    • 1160.53.90006 Boehringer Ingelheim Investigational Site
• Ukraine
  • Kiev, Ukraine
    • 1160.53.38006 Boehringer Ingelheim Investigational Site
  • Vinnitsa, Ukraine
    • 1160.53.38005 Boehringer Ingelheim Investigational Site
  • Zaporozhye, Ukraine
    • 1160.53.38003 Boehringer Ingelheim Investigational Site
• United Kingdom
  • Aberdeen, United Kingdom
    • 1160.53.44008 Boehringer Ingelheim Investigational Site
  • Headington, Oxford, United Kingdom
    • 1160.53.44005 Boehringer Ingelheim Investigational Site
  • London, United Kingdom
    • 1160.53.44004 Boehringer Ingelheim Investigational Site
  • London, United Kingdom
    • 1160.53.44009 Boehringer Ingelheim Investigational Site
  • London, United Kingdom
    • 1160.53.44011 Boehringer Ingelheim Investigational Site
  • Newcastle upon Tyne, United Kingdom
    • 1160.53.44006 Boehringer Ingelheim Investigational Site
  • Sheffield, United Kingdom
    • 1160.53.44012 Boehringer Ingelheim Investigational Site
• United States
  • Alabama
    • Mobile, Alabama, United States
      • 1160.53.01035 Boehringer Ingelheim Investigational Site
  • Connecticut
    • Hartford, Connecticut, United States
      • 1160.53.01056 Boehringer Ingelheim Investigational Site
  • Florida
    • Clearwater, Florida, United States
      • 1160.53.01044 Boehringer Ingelheim Investigational Site
    • Sarasota, Florida, United States
      • 1160.53.01033 Boehringer Ingelheim Investigational Site
    • Sarasota, Florida, United States
      • 1160.53.01046 Boehringer Ingelheim Investigational Site
  • Georgia
    • Augusta, Georgia, United States
      • 1160.53.01019 Boehringer Ingelheim Investigational Site
    • Decatur, Georgia, United States
      • 1160.53.01008 Boehringer Ingelheim Investigational Site
    • Marietta, Georgia, United States
      • 1160.53.01010 Boehringer Ingelheim Investigational Site
  • Maryland
    • Baltimore, Maryland, United States
      • 1160.53.01014 Boehringer Ingelheim Investigational Site
  • Michigan
    • Detroit, Michigan, United States
      • 1160.53.01023 Boehringer Ingelheim Investigational Site
    • Pontiac, Michigan, United States
      • 1160.53.01029 Boehringer Ingelheim Investigational Site
  • Minnesota
    • St. Louis Park, Minnesota, United States
      • 1160.53.01009 Boehringer Ingelheim Investigational Site
  • New Hampshire
    • Lebanon, New Hampshire, United States
      • 1160.53.01031 Boehringer Ingelheim Investigational Site
  • New Mexico
    • Albuquerque, New Mexico, United States
      • 1160.53.01036 Boehringer Ingelheim Investigational Site
  • New York
    • Valhalla, New York, United States
      • 1160.53.01025 Boehringer Ingelheim Investigational Site
  • North Carolina
    • Chapel Hill, North Carolina, United States
      • 1160.53.01027 Boehringer Ingelheim Investigational Site
    • Winston-Salem, North Carolina, United States
      • 1160.53.01039 Boehringer Ingelheim Investigational Site
  • North Dakota
    • Grand Forks, North Dakota, United States
      • 1160.53.01030 Boehringer Ingelheim Investigational Site
  • Ohio
    • Toledo, Ohio, United States
      • 1160.53.01013 Boehringer Ingelheim Investigational Site
  • Oregon
    • Portland, Oregon, United States
      • 1160.53.01028 Boehringer Ingelheim Investigational Site
  • Pennsylvania
    • Altoona, Pennsylvania, United States
      • 1160.53.01052 Boehringer Ingelheim Investigational Site
  • South Carolina
    • Summerville, South Carolina, United States
      • 1160.53.01055 Boehringer Ingelheim Investigational Site
  • Virginia
    • Richmond, Virginia, United States
      • 1160.53.01017 Boehringer Ingelheim Investigational Site

Participation Criteria

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

1. Acute deep vein thrombosis (DVT) of the leg involving proximal veins, and/or pulmonary embolism (PE) iin patients for whom at least 6 months of anticoagulant therapy is considered appropriate
2. Male or female, being 18 years of age or older
3. Written informed consent for study participation

Exclusion criteria

1. Overt symptoms of VTE for longer than 2 weeks prior to enrolment
2. PE satisfying at least one of the following criteria: Haemodynamic instability, embolectomy is indicated or performed, thrombolytic therapy is indicated or performed, or suspected source of PE is other than the legs
3. Actual or anticipated use of vena cava filter
4. Contraindications to anticoagulant therapy
5. Patients who in the investigators opinion should not be treated with warfarin
6. Allergy to heparins or other alternate approved therapy used for initial treatment, warfarin or dabigatran, or to one of the excipients included in these medications
7. Patients who in the investigators judgement are perceived as having an excessive risk of bleeding
8. Known anaemia
9. Need of anticoagulant treatment for disorders other than VTE
10. Recent unstable cardiovascular disease
11. Elevated AST or ALT > 2x ULN
12. Liver disease expected to have any potential impact on survival
13. Patients who have developed transaminase elevations upon exposure to ximelagatran
14. Severe renal impairment
15. Women who are pregnant, nursing, or of childbearing potential who refuse to use a medically acceptable form of contraception
16. Participation in another clinical trial with an investigational drug during the last 30 days or previous participation in this study
17. Patients considered unsuitable for inclusion by the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dabigatran etexilate 150 mg; twice daily	Drug: dabigatran etexilate 150 mg; twice daily
Active Comparator: warfarin (INR 2-3); prn to maintain INR (2-3)	Drug: warfarin (INR 2-3); prn to maintain INR (2-3)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE	All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.	For statistical analysis 1: from randomisation to end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Recurrent Symptomatic VTE and All Deaths	VTE or any death which occured from randomisation to end of post treatment period. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.	For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
Number of Participants With Recurrent Symptomatic DVT	Symptomatic DVT which occured from randomisation to end of post treatment period. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.	For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
Number of Participants With Recurrent Symptomatic Non-fatal PE	Symptomatic non-fatal PE which occured from randomisation to end of post treatment period. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.	For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
Number of Participants Who Died Due to VTE	VTE - related deaths which occured from randomisation to end of post treatment period. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.	For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
Number of Participants Who Died (Any Cause)	Any deaths which occured from randomisation to end of post treatment period. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.	For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
Number of Participants With Bleeding Events	Major bleeding events (MBE) were defined as; Fatal bleeding; Symptomatic bleeding in a critical area or organ; Bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells Clinically-relevant bleeding events (CRBE) was defined as; spontaneous skin hematoma >=25 cm²; spontaneous nose bleed >5 min; macroscopic hematuria spontaneous or >24 hours if associated with an intervention; spontaneous rectal bleeding (more than spotting on toilet paper); gingival bleeding >5 min; leading to hospitalisation and / or requiring surgical treatment; leading to a transfusion of <2 units of whole blood or red cells; any other bleeding event considered clinically relevant by the investigator Any bleeding events were defined as major, clinically-relevant and nuisance bleeding events. Nuisance bleeding events were defined as all other bleeding events that did not fulfil the criteria from above.	From first intake of study drug to last intake of study drug + 6 days washout (washout time can be reduced until 0 day if the patient takes an other anti-coagulant therapy on and after last intake of active study drug)
Number of Participants With Acute Coronary Syndrome (ACS)	Any ACS occurring during the conduct of the study (centrally adjudicated as definite). Counts of patients having a centrally adjudicated definite ACS during intake of active study drug, after stopping active study drug and before or without intake of active study drug, according to treatment group. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.	From first intake of study drug to end of study conduct
Laboratory Analyses	Frequency of patients with possible clinically significant abnormalities.	From first intake of study drug to last intake of study drug + 6 days washout (washout time can be reduced until 0 day if the patient takes an other anti-coagulant therapy on and after last intake of active study drug)

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

General Publications

• Majeed A, Hwang HG, Connolly SJ, Eikelboom JW, Ezekowitz MD, Wallentin L, Brueckmann M, Fraessdorf M, Yusuf S, Schulman S. Management and outcomes of major bleeding during treatment with dabigatran or warfarin. Circulation. 2013 Nov 19;128(21):2325-32. doi: 10.1161/CIRCULATIONAHA.113.002332. Epub 2013 Sep 30.
• Goldhaber SZ, Eriksson H, Kakkar A, Schellong S, Feuring M, Fraessdorf M, Kreuzer J, Schueler E, Schulman S. Efficacy of dabigatran versus warfarin in patients with acute venous thromboembolism in the presence of thrombophilia: Findings from RE-COVER(R), RE-COVER II, and RE-MEDY. Vasc Med. 2016 Dec;21(6):506-514. doi: 10.1177/1358863X16668588. Epub 2016 Nov 1.
• Schulman S, Kakkar AK, Goldhaber SZ, Schellong S, Eriksson H, Mismetti P, Christiansen AV, Friedman J, Le Maulf F, Peter N, Kearon C; RE-COVER II Trial Investigators. Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis. Circulation. 2014 Feb 18;129(7):764-72. doi: 10.1161/CIRCULATIONAHA.113.004450. Epub 2013 Dec 16.
• Schulman S, Kearon C, Kakkar AK, Mismetti P, Schellong S, Eriksson H, Baanstra D, Schnee J, Goldhaber SZ; RE-COVER Study Group. Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med. 2009 Dec 10;361(24):2342-52. doi: 10.1056/NEJMoa0906598.

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: February 13, 2006
• First Submitted That Met QC Criteria: February 13, 2006
• First Posted (Estimate): February 14, 2006

Study Record Updates

• Last Update Posted (Estimate): June 6, 2014
• Last Update Submitted That Met QC Criteria: June 3, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism; Venous Thromboembolism; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Dabigatran; Warfarin
• Other Study ID Numbers: 1160.53; 2005-001999-12 (EudraCT Number: EudraCT)