Secondary Prevention of Venous Thrombo Embolism (VTE).

NCT00329238 | Completed Phase 3 Results

• 2 other identifiers: 1160.472005-002536-94
• Study Type: interventional
• Target: 2,867
• Locations: 32 countries
• Sites: 271

Brief Summary

The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate administered orally and warfarin (International Normalized Ratio (INR) of 2.0-3.0) for the long-term treatment and secondary prevention of symptomatic venous thromboembolism in patients who have been successfully treated with standard doses of an approved anticoagulant for three to twelve months for confirmed acute symptomatic Venous Thrombo-embolism.

Conditions

Thromboembolism

Outcome Measures

Primary Outcomes (2)

• Composite of Recurrent VTE or VTE Death at 36 Months

  Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE.

  36 months

• Composite of Recurrent VTE or VTE Death at 18 Months

  Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE.

  18 months

Secondary Outcomes (13)

• Composite of Recurrent VTE or All Cause Death at 36 Months

  36 months

• Composite of Recurrent VTE or All Cause Death at 18 Months

  18 months

• Deep Vein Thrombosis (DVT) at 36 Months

  36 months

• DVT at 18 Months

  18 months

• Symptomatic Pulmonary Embolism (PE) at 36 Months

  36 months

Study Arms (2)

Dabigatran

EXPERIMENTAL

Patient to receive 1 capsule containing dabigatran 150 mg twice daily plus placebo tablets for warfarin as decided by sham INR measurements

Drug: Dabigatran

Warfarin (INR of 2.0-3.0)

ACTIVE COMPARATOR

Patient to receive warfarin tablets to target INR 2.0-3.0 plus placebo capsules for dabigatran twice daily

Drug: Warfarin

Interventions

Dabigatran DRUG

Dabigatran 150 mg BID (twice daily)

Dabigatran

Warfarin DRUG

Warfarin dosed individually to maintain INR 2.0-3.0

Warfarin (INR of 2.0-3.0)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute symptomatic deep vein thrombosis (DVT)
• Pulmonary embolism (PE) 3-12 months prior to screening, which has been documented by objective testing

You may not qualify if:

• Symptomatic DVT or PE at screening Interruption of anticoagulant therapy for 2 or more weeks during the 3-12 months of treatment for the prior VTE.
• Patients who in the investigators judgement are perceived as having an excessive risk of bleeding Elevated Aspartate aminotransferase (AST) or Alanine tranminase (ALT) \> 2x ULN
• Severe renal impairment (estimated creatinine clearance \<= 30 ml/min)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (275)

1160.47.01035 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

Location

1160.47.01056 Boehringer Ingelheim Investigational Site

Hartford, Connecticut, United States

Location

1160.47.01044 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

Location

1160.47.01019 Boehringer Ingelheim Investigational Site

Augusta, Georgia, United States

Location

1160.47.01008 Boehringer Ingelheim Investigational Site

Decatur, Georgia, United States

Location

1160.47.01014 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

Location

1160.47.01018 Boehringer Ingelheim Investigational Site

Roxbury Crossing, Massachusetts, United States

Location

1160.47.01023 Boehringer Ingelheim Investigational Site

Detroit, Michigan, United States

Location

1160.47.01009 Boehringer Ingelheim Investigational Site

Saint Louis Park, Minnesota, United States

Location

1160.47.01031 Boehringer Ingelheim Investigational Site

Lebanon, New Hampshire, United States

Location

1160.47.01036 Boehringer Ingelheim Investigational Site

Albuquerque, New Mexico, United States

Location

1160.47.01027 Boehringer Ingelheim Investigational Site

Chapel Hill, North Carolina, United States

Location

1160.47.01039 Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

Location

1160.47.01030 Boehringer Ingelheim Investigational Site

Grand Forks, North Dakota, United States

Location

1160.47.01013 Boehringer Ingelheim Investigational Site

Toledo, Ohio, United States

Location

1160.47.01052 Boehringer Ingelheim Investigational Site

Altoona, Pennsylvania, United States

Location

1160.47.01055 Boehringer Ingelheim Investigational Site

Summerville, South Carolina, United States

Location

1160.47.01017 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Location

1160.47.54017 Boehringer Ingelheim Investigational Site

Adrogué, Argentina

Location

1160.47.54015 Boehringer Ingelheim Investigational Site

Bahía Blanca, Argentina

Location

1160.47.54001 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

1160.47.54003 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

1160.47.54005 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

1160.47.54006 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

1160.47.54007 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

1160.47.54010 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

1160.47.54016 Boehringer Ingelheim Investigational Site

La Plata, Argentina

Location

1160.47.54014 Boehringer Ingelheim Investigational Site

Mar del Plata, Argentina

Location

1160.47.54013 Boehringer Ingelheim Investigational Site

Quilmes, Argentina

Location

1160.47.54011 Boehringer Ingelheim Investigational Site

Rosario, Argentina

Location

1160.47.54018 Boehringer Ingelheim Investigational Site

Salta, Argentina

Location

1160.47.54012 Boehringer Ingelheim Investigational Site

Santa Fe, Argentina

Location

1160.47.61002 Princess Alexandra Hospital

Wooloongabba, Queensland, Australia

Location

1160.47.61004 Boehringer Ingelheim Investigational Site

Bedford Park, South Australia, Australia

Location

1160.47.61003 Boehringer Ingelheim Investigational Site

Box Hill, Victoria, Australia

Location

1160.47.61001 Boehringer Ingelheim Investigational Site

Clayton, Victoria, Australia

Location

1160.47.61006 Boehringer Ingelheim Investigational Site

Windsor, Victoria, Australia

Location

1160.47.61005 Boehringer Ingelheim Investigational Site

Perth, Western Australia, Australia

Location

1160.47.43001 Boehringer Ingelheim Investigational Site

Graz, Austria

Location

1160.47.43003 Boehringer Ingelheim Investigational Site

Innsbruck, Austria

Location

1160.47.43002 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

1160.47.43004 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

1160.47.32001 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1160.47.32002 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1160.47.32005 Boehringer Ingelheim Investigational Site

Leuven, Belgium

Location

1160.47.32004 Boehringer Ingelheim Investigational Site

Liège, Belgium

Location

1160.47.55010 Boehringer Ingelheim Investigational Site

Brasília, Brazil

Location

1160.47.55007 Boehringer Ingelheim Investigational Site

Campinas - SP, Brazil

Location

1160.47.55014 Boehringer Ingelheim Investigational Site

Curitiba, Brazil

Location

1160.47.55017 Boehringer Ingelheim Investigational Site

Juvene - Paraná -, Brazil

Location

1160.47.55012 Boehringer Ingelheim Investigational Site

pTO aLEGRE, Brazil

Location

1160.47.55016 Boehringer Ingelheim Investigational Site

Rio de Janeiro - RJ, Brazil

Location

1160.47.55018 Boehringer Ingelheim Investigational Site

São Bernardo do Campo, Brazil

Location

1160.47.55005 Boehringer Ingelheim Investigational Site

São José do Rio Preto, Brazil

Location

1160.47.35910 Boehringer Ingelheim Investigational Site

Plovdiv, Bulgaria

Location

1160.47.35908 Boehringer Ingelheim Investigational Site

Rousse, Bulgaria

Location

1160.47.35901 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

1160.47.35903 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

1160.47.35904 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

1160.47.35906 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

1160.47.35907 Boehringer Ingelheim Investigational Site

Sofia, Bulgaria

Location

1160.47.35905 Boehringer Ingelheim Investigational Site

Varna, Bulgaria

Location

1160.47.02006 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

Location

1160.47.02013 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

Location

1160.47.02021 Boehringer Ingelheim Investigational Site

Victoria, British Columbia, Canada

Location

1160.47.02004 Boehringer Ingelheim Investigational Site

Saint Johns, New Brunswick, Canada

Location

1160.47.02001 Boehringer Ingelheim Investigational Site

Halifax, Nova Scotia, Canada

Location

1160.47.02002 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Location

1160.47.02005 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Location

1160.47.02010 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Location

1160.47.02022 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Location

1160.47.02015 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

Location

1160.47.02019 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

1160.47.02008 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

1160.47.02009 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

1160.47.02014 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

1160.47.02017 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

1160.47.86001 Boehringer Ingelheim Investigational Site

Beijing, China

Location

1160.47.86015 Boehringer Ingelheim Investigational Site

Beijing, China

Location

1160.47.86014 Boehringer Ingelheim Investigational Site

Chengdu, China

Location

1160.47.86012 Boehringer Ingelheim Investigational Site

Guangzhou, China

Location

1160.47.86009 Boehringer Ingelheim Investigational Site

Hangzhou, China

Location

1160.47.86010 Boehringer Ingelheim Investigational Site

Hangzhou, China

Location

1160.47.86013 Boehringer Ingelheim Investigational Site

Nanjing, China

Location

1160.47.86002 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

1160.47.86003 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

1160.47.86004 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

1160.47.86005 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

1160.47.86006 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

1160.47.86007 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

1160.47.86016 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

1160.47.86011 Boehringer Ingelheim Investigational Site

Shijiazhuang, China

Location

1160.47.42001 Boehringer Ingelheim Investigational Site

Brno, Czechia

Location

1160.47.42002 Boehringer Ingelheim Investigational Site

Hradec Králové, Czechia

Location

1160.47.42011 Boehringer Ingelheim Investigational Site

Hranice, Czechia

Location

1160.47.42012 Boehringer Ingelheim Investigational Site

Liberec, Czechia

Location

1160.47.42015 Boehringer Ingelheim Investigational Site

Nový Jičín, Czechia

Location

1160.47.42005 Boehringer Ingelheim Investigational Site

Ostrava-Vitkovice, Czechia

Location

1160.47.42004 Boehringer Ingelheim Investigational Site

Prague, Czechia

Location

1160.47.42014 Boehringer Ingelheim Investigational Site

Tábor, Czechia

Location

1160.47.42010 Boehringer Ingelheim Investigational Site

Ústí nad Labem, Czechia

Location

1160.47.42007 Boehringer Ingelheim Investigational Site

Zlín, Czechia

Location

1160.47.45008 Boehringer Ingelheim Investigational Site

Esbjerg, Denmark

Location

1160.47.45009 Boehringer Ingelheim Investigational Site

Holbæk, Denmark

Location

1160.47.45002 Boehringer Ingelheim Investigational Site

Kolding, Denmark

Location

1160.47.45004 Boehringer Ingelheim Investigational Site

København NV, Denmark

Location

1160.47.45007 Boehringer Ingelheim Investigational Site

København S, Denmark

Location

1160.47.45006 Boehringer Ingelheim Investigational Site

Slagelse, Denmark

Location

1160.47.35804 Boehringer Ingelheim Investigational Site

Espoo, Finland

Location

1160.47.35801 Boehringer Ingelheim Investigational Site

Helsinki, Finland

Location

1160.47.35802 Boehringer Ingelheim Investigational Site

Jyväskylä, Finland

Location

1160.47.35805 Boehringer Ingelheim Investigational Site

Kuopio, Finland

Location

1160.47.35803 Boehringer Ingelheim Investigational Site

Tampere, Finland

Location

1160.47.3301A Boehringer Ingelheim Investigational Site

Brest, France

Location

1160.47.3301B Boehringer Ingelheim Investigational Site

Brest, France

Location

1160.47.3301C Boehringer Ingelheim Investigational Site

Brest, France

Location

1160.47.3301D Boehringer Ingelheim Investigational Site

Brest, France

Location

1160.47.3301E Boehringer Ingelheim Investigational Site

Brest, France

Location

1160.47.3301F Boehringer Ingelheim Investigational Site

Brest, France

Location

1160.47.3301H Boehringer Ingelheim Investigational Site

Brest, France

Location

1160.47.3301I Boehringer Ingelheim Investigational Site

Brest, France

Location

1160.47.3302A Boehringer Ingelheim Investigational Site

Lorient, France

Location

1160.47.3303A Boehringer Ingelheim Investigational Site

Saint-Etienne, France

Location

1160.47.3303B Boehringer Ingelheim Investigational Site

Saint-Etienne, France

Location

1160.47.3303C Boehringer Ingelheim Investigational Site

Saint-Etienne, France

Location

1160.47.3303D Boehringer Ingelheim Investigational Site

Saint-Etienne, France

Location

1160.47.3308A Boehringer Ingelheim Investigational Site

Vandœuvre-lès-Nancy, France

Location

1160.47.49003 Boehringer Ingelheim Investigational Site

Cologne, Germany

Location

1160.47.49017 Boehringer Ingelheim Investigational Site

Dresden, Germany

Location

1160.47.49018 Boehringer Ingelheim Investigational Site

Dresden, Germany

Location

1160.47.49005 Boehringer Ingelheim Investigational Site

Mannheim, Germany

Location

1160.47.49006 Boehringer Ingelheim Investigational Site

Mannheim, Germany

Location

1160.47.49007 Boehringer Ingelheim Investigational Site

München, Germany

Location

1160.47.49008 Boehringer Ingelheim Investigational Site

München, Germany

Location

1160.47.49009 Boehringer Ingelheim Investigational Site

Püttlingen, Germany

Location

1160.47.30001 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1160.47.30006 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1160.47.30007 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1160.47.30009 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1160.47.36001 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

1160.47.36006 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

1160.47.36007 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

1160.47.36002 Boehringer Ingelheim Investigational Site

Debrecen, Hungary

Location

1160.47.36012 Boehringer Ingelheim Investigational Site

Gyula, Hungary

Location

1160.47.36004 Boehringer Ingelheim Investigational Site

Miskolc, Hungary

Location

1160.47.36003 Boehringer Ingelheim Investigational Site

Pécs, Hungary

Location

1160.47.36010 Boehringer Ingelheim Investigational Site

Székesfehérvár, Hungary

Location

1160.47.36011 Boehringer Ingelheim Investigational Site

Szombathely, Hungary

Location

1160.47.91002 Boehringer Ingelheim Investigational Site

Ahmedabad, India

Location

1160.47.91011 Boehringer Ingelheim Investigational Site

Bangalore, India

Location

1160.47.91015 Boehringer Ingelheim Investigational Site

Bangalore, India

Location

1160.47.91012 Boehringer Ingelheim Investigational Site

Chennai, India

Location

1160.47.91017 Boehringer Ingelheim Investigational Site

Chennai, India

Location

1160.47.91009 Boehringer Ingelheim Investigational Site

Madurai, India

Location

1160.47.91007 Boehringer Ingelheim Investigational Site

Mysore, India

Location

1160.47.91003 Boehringer Ingelheim Investigational Site

New Delhi, India

Location

1160.47.91006 Boehringer Ingelheim Investigational Site

New Delhi, India

Location

1160.47.91010 Boehringer Ingelheim Investigational Site

New Delhi, India

Location

1160.47.91001 Boehringer Ingelheim Investigational Site

Pune, India

Location

1160.47.91005 Boehringer Ingelheim Investigational Site

Pune, India

Location

1160.47.91008 Boehringer Ingelheim Investigational Site

Pune, India

Location

1160.47.91014 Boehringer Ingelheim Investigational Site

Trivandrum, India

Location

1160.47.91004 Boehringer Ingelheim Investigational Site

Vadodara, India

Location

1160.47.97202 Boehringer Ingelheim Investigational Site

Afula, Israel

Location

1160.47.97207 Boehringer Ingelheim Investigational Site

Ashkelon, Israel

Location

1160.47.97211 Boehringer Ingelheim Investigational Site

Haifa, Israel

Location

1160.47.97203 Boehringer Ingelheim Investigational Site

Holon, Israel

Location

1160.47.97205 Boehringer Ingelheim Investigational Site

Kfar Saba, Israel

Location

1160.47.97206 Boehringer Ingelheim Investigational Site

Petah Tikva, Israel

Location

1160.47.97208 Boehringer Ingelheim Investigational Site

Rehovot, Israel

Location

1160.47.97210 Boehringer Ingelheim Investigational Site

Tel Aviv, Israel

Location

1160.47.97204 Boehringer Ingelheim Investigational Site

Tel Litwinsky, Israel

Location

1160.47.97201 Boehringer Ingelheim Investigational Site

Ẕerifin, Israel

Location

1160.47.39003 Boehringer Ingelheim Investigational Site

Bologna, Italy

Location

1160.47.39004 Boehringer Ingelheim Investigational Site

Cremona, Italy

Location

1160.47.39006 Boehringer Ingelheim Investigational Site

Genova, Italy

Location

1160.47.39008 Boehringer Ingelheim Investigational Site

Milan, Italy

Location

1160.47.39007 Boehringer Ingelheim Investigational Site

Reggio Emilia, Italy

Location

1160.47.39009 Boehringer Ingelheim Investigational Site

Udine, Italy

Location

1160.47.39005 Boehringer Ingelheim Investigational Site

Vittorio Veneto, Italy

Location

1160.47.52036 Boehringer Ingelheim Investigational Site

Chihuahua City, Mexico

Location

1160.47.52039 Boehringer Ingelheim Investigational Site

Culiacán, Mexico

Location

1160.47.52030 Boehringer Ingelheim Investigational Site

Guadalajara, Jal., Mexico

Location

1160.47.52027 Boehringer Ingelheim Investigational Site

Monterrey, Mexico

Location

1160.47.52034 Boehringer Ingelheim Investigational Site

San Luis Potosí City, Mexico

Location

1160.47.31010 Boehringer Ingelheim Investigational Site

's-Hertogenbosch, Netherlands

Location

1160.47.31001 Boehringer Ingelheim Investigational Site

Amersfoort, Netherlands

Location

1160.47.31006 Boehringer Ingelheim Investigational Site

Amsterdam, Netherlands

Location

1160.47.31007 Boehringer Ingelheim Investigational Site

Amsterdam, Netherlands

Location

1160.47.31014 Boehringer Ingelheim Investigational Site

Heerlen, Netherlands

Location

1160.47.31005 Boehringer Ingelheim Investigational Site

Maastricht, Netherlands

Location

1160.47.31004 Boehringer Ingelheim Investigational Site

Rotterdam, Netherlands

Location

1160.47.31009 Boehringer Ingelheim Investigational Site

Rotterdam, Netherlands

Location

1160.47.64004 Boehringer Ingelheim Investigational Site

Christchurch, New Zealand

Location

1160.47.64003 Boehringer Ingelheim Investigational Site

Grafton, New Zealand

Location

1160.47.64002 Boehringer Ingelheim Investigational Site

Otahuhu, New Zealand

Location

1160.47.64001 Boehringer Ingelheim Investigational Site

Takapuna Auckland 9, New Zealand

Location

1160.47.47001 Boehringer Ingelheim Investigational Site

Oslo, Norway

Location

1160.47.47004 Boehringer Ingelheim Investigational Site

Oslo, Norway

Location

1160.47.47003 Boehringer Ingelheim Investigational Site

Rud, Norway

Location

1160.47.47005 Boehringer Ingelheim Investigational Site

Trondheim, Norway

Location

1160.47.48004 Boehringer Ingelheim Investigational Site

Kielce, Poland

Location

1160.47.48005 Boehringer Ingelheim Investigational Site

Krakow, Poland

Location

1160.47.48007 Boehringer Ingelheim Investigational Site

Krakow, Poland

Location

1160.47.48003 Boehringer Ingelheim Investigational Site

Poznan, Poland

Location

1160.47.48006 Boehringer Ingelheim Investigational Site

Warsaw, Poland

Location

1160.47.35104 Boehringer Ingelheim Investigational Site

Almada, Portugal

Location

1160.47.35109 Boehringer Ingelheim Investigational Site

Coimbra, Portugal

Location

1160.47.35107 Boehringer Ingelheim Investigational Site

Covilha, Portugal

Location

1160.47.35101 Boehringer Ingelheim Investigational Site

Lisbon, Portugal

Location

1160.47.35102 Boehringer Ingelheim Investigational Site

Lisbon, Portugal

Location

1160.47.35105 Boehringer Ingelheim Investigational Site

Lisbon, Portugal

Location

1160.47.07022 Boehringer Ingelheim Investigational Site

Belgorod, Russia

Location

1160.47.07011 Boehringer Ingelheim Investigational Site

Chelyabinsk, Russia

Location

1160.47.07021 Boehringer Ingelheim Investigational Site

Chelyabinsk, Russia

Location

1160.47.07016 Boehringer Ingelheim Investigational Site

Krasnodar, Russia

Location

1160.47.07004 Boehringer Ingelheim Investigational Site

Kursk, Russia

Location

1160.47.07010 Boehringer Ingelheim Investigational Site

Novosibirsk, Russia

Location

1160.47.07020 Boehringer Ingelheim Investigational Site

Omsk, Russia

Location

1160.47.07018 Boehringer Ingelheim Investigational Site

Pskov, Russia

Location

1160.47.07009 Boehringer Ingelheim Investigational Site

Rostov-on-Don, Russia

Location

1160.47.07023 Boehringer Ingelheim Investigational Site

Rostov-on-Don, Russia

Location

1160.47.07024 Boehringer Ingelheim Investigational Site

Rostov-on-Don, Russia

Location

1160.47.07025 Boehringer Ingelheim Investigational Site

Rostov-on-Don, Russia

Location

1160.47.07001 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1160.47.07002 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1160.47.07017 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1160.47.07019 Boehringer Ingelheim Investigational Site

Tyumen, Russia

Location

1160.47.07014 Boehringer Ingelheim Investigational Site

Ufa, Russia

Location

1160.47.07005 Boehringer Ingelheim Investigational Site

Yaroslavl, Russia

Location

1160.47.07006 Boehringer Ingelheim Investigational Site

Yaroslavl, Russia

Location

1160.47.07007 Boehringer Ingelheim Investigational Site

Yekaterinburg, Russia

Location

1160.47.42107 Boehringer Ingelheim Investigational Site

Banská Bystrica, Slovakia

Location

1160.47.42106 Boehringer Ingelheim Investigational Site

Lučenec, Slovakia

Location

1160.47.42102 Boehringer Ingelheim Investigational Site

Nitra, Slovakia

Location

1160.47.42103 Boehringer Ingelheim Investigational Site

Nové Zámky, Slovakia

Location

1160.47.42104 Boehringer Ingelheim Investigational Site

Žilina, Slovakia

Location

1160.47.27001 Boehringer Ingelheim Investigational Site

Johannesburg, South Africa

Location

1160.47.27002 Boehringer Ingelheim Investigational Site

Johannesburg, South Africa

Location

1160.47.27006 Boehringer Ingelheim Investigational Site

Johannesburg, South Africa

Location

1160.47.27007

Pretoria, South Africa

Location

1160.47.27003 Boehringer Ingelheim Investigational Site

Randburg, South Africa

Location

1160.47.27005 Boehringer Ingelheim Investigational Site

Roodepoort, South Africa

Location

1160.47.34006 Boehringer Ingelheim Investigational Site

Alicante, Spain

Location

1160.47.34012 Boehringer Ingelheim Investigational Site

Badalona (Barcelona), Spain

Location

1160.47.34001 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1160.47.34002 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1160.47.34007 Boehringer Ingelheim Investigational Site

Cartagena. Murcia, Spain

Location

1160.47.34003 Boehringer Ingelheim Investigational Site

Cuenca, Spain

Location

1160.47.34009 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1160.47.34004 Boehringer Ingelheim Investigational Site

Santander, Spain

Location

1160.47.34011 Boehringer Ingelheim Investigational Site

Valencia, Spain

Location

1160.47.46002 Boehringer Ingelheim Investigational Site

Gothenburg, Sweden

Location

1160.47.46006 Boehringer Ingelheim Investigational Site

Jönköping, Sweden

Location

1160.47.46001 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

1160.47.46007 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

1160.47.46008 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

1160.47.46005 Boehringer Ingelheim Investigational Site

Sundsvall, Sweden

Location

1160.47.46003 Boehringer Ingelheim Investigational Site

Uppsala, Sweden

Location

1160.47.90003 Boehringer Ingelheim Investigational Site

Ankara, Turkey (Türkiye)

Location

1160.47.90004 Boehringer Ingelheim Investigational Site

Ankara, Turkey (Türkiye)

Location

1160.47.90005 Boehringer Ingelheim Investigational Site

Ankara, Turkey (Türkiye)

Location

1160.47.90001 Boehringer Ingelheim Investigational Site

Istanbul, Turkey (Türkiye)

Location

1160.47.90002 Boehringer Ingelheim Investigational Site

Istanbul, Turkey (Türkiye)

Location

1160.47.90007 Boehringer Ingelheim Investigational Site

Istanbul, Turkey (Türkiye)

Location

1160.47.90006 Boehringer Ingelheim Investigational Site

Izmir, Turkey (Türkiye)

Location

1160.47.38002 Boehringer Ingelheim Investigational Site

Kharkiv, Ukraine

Location

1160.47.38006 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1160.47.38005 Boehringer Ingelheim Investigational Site

Vinnitsa, Ukraine

Location

1160.47.38003 Boehringer Ingelheim Investigational Site

Zaporizhzhya, Ukraine

Location

1160.47.44005 Boehringer Ingelheim Investigational Site

Headington, Oxford, United Kingdom

Location

1160.47.44009 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1160.47.44011 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1160.47.44006 Boehringer Ingelheim Investigational Site

Newcastle upon Tyne, United Kingdom

Location

1160.47.44012 Boehringer Ingelheim Investigational Site

Sheffield, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 27807306 DERIVED

• 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.

  PMID: 24081972 DERIVED

• Schulman S, Kearon C, Kakkar AK, Schellong S, Eriksson H, Baanstra D, Kvamme AM, Friedman J, Mismetti P, Goldhaber SZ; RE-MEDY Trial Investigators; RE-SONATE Trial Investigators. Extended use of dabigatran, warfarin, or placebo in venous thromboembolism. N Engl J Med. 2013 Feb 21;368(8):709-18. doi: 10.1056/NEJMoa1113697.

  PMID: 23425163 DERIVED

MeSH Terms

Conditions

Thromboembolism

Interventions

Dabigatran; Warfarin

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2006
• First Posted: May 24, 2006
• Study Start: May 1, 2006
• Primary Completion: October 1, 2010
• Last Updated: May 19, 2014
• Results First Posted: September 14, 2011

Record last verified: 2013-12

Locations

GR (4); HU (9); ME (5); RU (20); NO (4); FR (14); NL (8); NZ (4); CZ (10); AR (14); ZA (6); GB (5); BR (8); BU (8); BE (4); CN (15); ES (9); IN (15); SE (7); AU (6); PT (6); DK (6); CA (15); US (18); IT (7); DE (8); TU (7); IL (10); UA (4); FI (5); SL (5); PL (5)