Efficacy and Safety of Dabigatran Compared to Warfarin for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism

NCT00291330 | Completed Phase 3 Results

• 2 other identifiers: 1160.532005-001999-12
• Study Type: interventional
• Target: 2,564
• Locations: 28 countries
• Sites: 247

Brief Summary

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.

Conditions

Thromboembolism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Number of Participants With Recurrent Symptomatic VTE and All Deaths

  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

  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

  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

  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)

  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.

Study Arms (2)

dabigatran etexilate 150 mg

EXPERIMENTAL

twice daily

Drug: dabigatran etexilate 150 mg

warfarin (INR 2-3)

ACTIVE COMPARATOR

prn to maintain INR (2-3)

Drug: warfarin (INR 2-3)

Interventions

dabigatran etexilate 150 mg DRUG

twice daily

dabigatran etexilate 150 mg

warfarin (INR 2-3) DRUG

prn to maintain INR (2-3)

warfarin (INR 2-3)

Eligibility Criteria

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

You may qualify if:

• 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
• Male or female, being 18 years of age or older
• Written informed consent for study participation

You may not qualify if:

• Overt symptoms of VTE for longer than 2 weeks prior to enrolment
• 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
• Actual or anticipated use of vena cava filter
• Contraindications to anticoagulant therapy
• Patients who in the investigators opinion should not be treated with warfarin
• 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
• Patients who in the investigators judgement are perceived as having an excessive risk of bleeding
• Known anaemia
• Need of anticoagulant treatment for disorders other than VTE
• Recent unstable cardiovascular disease
• Elevated AST or ALT \> 2x ULN
• Liver disease expected to have any potential impact on survival
• Patients who have developed transaminase elevations upon exposure to ximelagatran
• Severe renal impairment
• Women who are pregnant, nursing, or of childbearing potential who refuse to use a medically acceptable form of contraception

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (250)

1160.53.01035 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

Location

1160.53.01056 Boehringer Ingelheim Investigational Site

Hartford, Connecticut, United States

Location

1160.53.01044 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

Location

1160.53.01033 Boehringer Ingelheim Investigational Site

Sarasota, Florida, United States

Location

1160.53.01046 Boehringer Ingelheim Investigational Site

Sarasota, Florida, United States

Location

1160.53.01019 Boehringer Ingelheim Investigational Site

Augusta, Georgia, United States

Location

1160.53.01008 Boehringer Ingelheim Investigational Site

Decatur, Georgia, United States

Location

1160.53.01010 Boehringer Ingelheim Investigational Site

Marietta, Georgia, United States

Location

1160.53.01014 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

Location

1160.53.01023 Boehringer Ingelheim Investigational Site

Detroit, Michigan, United States

Location

1160.53.01029 Boehringer Ingelheim Investigational Site

Pontiac, Michigan, United States

Location

1160.53.01009 Boehringer Ingelheim Investigational Site

Saint Louis Park, Minnesota, United States

Location

1160.53.01031 Boehringer Ingelheim Investigational Site

Lebanon, New Hampshire, United States

Location

1160.53.01036 Boehringer Ingelheim Investigational Site

Albuquerque, New Mexico, United States

Location

1160.53.01025 Boehringer Ingelheim Investigational Site

Valhalla, New York, United States

Location

1160.53.01027 Boehringer Ingelheim Investigational Site

Chapel Hill, North Carolina, United States

Location

1160.53.01039 Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

Location

1160.53.01030 Boehringer Ingelheim Investigational Site

Grand Forks, North Dakota, United States

Location

1160.53.01013 Boehringer Ingelheim Investigational Site

Toledo, Ohio, United States

Location

1160.53.01028 Boehringer Ingelheim Investigational Site

Portland, Oregon, United States

Location

1160.53.01052 Boehringer Ingelheim Investigational Site

Altoona, Pennsylvania, United States

Location

1160.53.01055 Boehringer Ingelheim Investigational Site

Summerville, South Carolina, United States

Location

1160.53.01017 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Location

1160.53.54017 Boehringer Ingelheim Investigational Site

Adrogué, Argentina

Location

1160.53.54003 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

1160.53.54005 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

1160.53.54006 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

1160.53.54007 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

1160.53.54010 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

1160.53.61002 Boehringer Ingelheim Investigational Site

Woolloongabba, Queensland, Australia

Location

1160.53.61004 Boehringer Ingelheim Investigational Site

Bedford Park, South Australia, Australia

Location

1160.53.61003 Boehringer Ingelheim Investigational Site

Box Hill, Victoria, Australia

Location

1160.53.61001 Boehringer Ingelheim Investigational Site

Clayton, Victoria, Australia

Location

1160.53.61006 The Avenue Cardiovascular Centre

Windsor, Victoria, Australia

Location

1160.53.61005 Boehringer Ingelheim Investigational Site

Perth, Western Australia, Australia

Location

1160.53.43001 Boehringer Ingelheim Investigational Site

Graz, Austria

Location

1160.53.43003 Boehringer Ingelheim Investigational Site

Innsbruck, Austria

Location

1160.53.43002 Boehringer Ingelheim Investigational Site

Vienna, Austria

Location

1160.53.32001 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1160.53.32002 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1160.53.32003 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1160.53.32007 Boehringer Ingelheim Investigational Site

Edegem, Belgium

Location

1160.53.32005 Boehringer Ingelheim Investigational Site

Leuven, Belgium

Location

1160.53.32004 Boehringer Ingelheim Investigational Site

Liège, Belgium

Location

1160.53.55010 Boehringer Ingelheim Investigational Site

Brasília, Brazil

Location

1160.53.55007 Boehringer Ingelheim Investigational Site

Campinas, Brazil

Location

1160.53.55001 Boehringer Ingelheim Investigational Site

Cerqueira César - Sao Paulo, Brazil

Location

1160.53.55002 Boehringer Ingelheim Investigational Site

Cerqueira César - São Paulo, Brazil

Location

1160.53.55014 Boehringer Ingelheim Investigational Site

Cristo Rei - Curitiba, Brazil

Location

1160.53.55011 Boehringer Ingelheim Investigational Site

Goiânia, Brazil

Location

1160.53.55017 Boehringer Ingelheim Investigational Site

Paraná, Brazil

Location

1160.53.55012 Boehringer Ingelheim Investigational Site

Porto Alegre, Brazil

Location

1160.53.55016 Boehringer Ingelheim Investigational Site

Rio de Janeiro - RJ, Brazil

Location

1160.53.55004 Boehringer Ingelheim Investigational Site

Santo André, Brazil

Location

1160.53.55005 Boehringer Ingelheim Investigational Site

São José do Rio Preto, Brazil

Location

1160.53.02006 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

Location

1160.53.02013 Boehringer Ingelheim Investigational Site

Edmonton, Alberta, Canada

Location

1160.53.02021 Boehringer Ingelheim Investigational Site

Victoria, British Columbia, Canada

Location

1160.53.02004 Boehringer Ingelheim Investigational Site

Saint Johns, New Brunswick, Canada

Location

1160.53.02001 Boehringer Ingelheim Investigational Site

Halifax, Nova Scotia, Canada

Location

1160.53.02002 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Location

1160.53.02005 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Location

1160.53.02010 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Location

1160.53.02022 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Location

1160.53.02011 Boehringer Ingelheim Investigational Site

London, Ontario, Canada

Location

1160.53.02015 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

Location

1160.53.02019 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

1160.53.02008 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

1160.53.02009 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

1160.53.02014 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

1160.53.02017 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

1160.53.02020 Boehringer Ingelheim Investigational Site

Québec, Quebec, Canada

Location

1160.53.02003 Boehringer Ingelheim Investigational Site

Sainte-Foy, Quebec, Canada

Location

1160.53.42001 Boehringer Ingelheim Investigational Site

Brno, Czechia

Location

1160.53.42002 Boehringer Ingelheim Investigational Site

Hradec Králové, Czechia

Location

1160.53.42011 Boehringer Ingelheim Investigational Site

Hranice, Czechia

Location

1160.53.42009 Boehringer Ingelheim Investigational Site

Jihlava, Czechia

Location

1160.53.42012 Boehringer Ingelheim Investigational Site

Liberec, Czechia

Location

1160.53.42015 Boehringer Ingelheim Investigational Site

Nový Jičín, Czechia

Location

1160.53.42005 Boehringer Ingelheim Investigational Site

Ostrava-Vitkovice, Czechia

Location

1160.53.42004 Boehringer Ingelheim Investigational Site

Prague, Czechia

Location

1160.53.42014 Boehringer Ingelheim Investigational Site

Tábor, Czechia

Location

1160.53.42016 Boehringer Ingelheim Investigational Site

Teplice, Czechia

Location

1160.53.42010 Boehringer Ingelheim Investigational Site

Ústí nad Labem, Czechia

Location

1160.53.42007 Boehringer Ingelheim Investigational Site

Zlín, Czechia

Location

1160.53.45008 Boehringer Ingelheim Investigational Site

Esbjerg, Denmark

Location

1160.53.45009 Boehringer Ingelheim Investigational Site

Holbæk, Denmark

Location

1160.53.45002 Boehringer Ingelheim Investigational Site

Kolding, Denmark

Location

1160.53.45004 Boehringer Ingelheim Investigational Site

København NV, Denmark

Location

1160.53.45007 Boehringer Ingelheim Investigational Site

København S, Denmark

Location

1160.53.45006 Boehringer Ingelheim Investigational Site

Slagelse, Denmark

Location

1160.53.3301A Boehringer Ingelheim Investigational Site

Brest, France

Location

1160.53.3301B Boehringer Ingelheim Investigational Site

Brest, France

Location

1160.53.3301C Boehringer Ingelheim Investigational Site

Brest, France

Location

1160.53.3301D Boehringer Ingelheim Investigational Site

Brest, France

Location

1160.53.3301E Boehringer Ingelheim Investigational Site

Brest, France

Location

1160.53.3301F Boehringer Ingelheim Investigational Site

Brest, France

Location

1160.53.3301H Boehringer Ingelheim Investigational Site

Brest, France

Location

1160.53.3301I Boehringer Ingelheim Investigational Site

Brest, France

Location

1160.53.3302A Boehringer Ingelheim Investigational Site

Lorient, France

Location

1160.53.3310A Boehringer Ingelheim Investigational Site

Montpellier, France

Location

1160.53.3310B Boehringer Ingelheim Investigational Site

Montpellier, France

Location

1160.53.3310C Boehringer Ingelheim Investigational Site

Montpellier, France

Location

1160.53.3308B Boehringer Ingelheim Investigational Site

Nancy, France

Location

1160.53.3303B Boehringer Ingelheim Investigational Site

Saint-Etienne, France

Location

1160.53.3303C Boehringer Ingelheim Investigational Site

Saint-Etienne, France

Location

1160.53.3303D Boehringer Ingelheim Investigational Site

Saint-Etienne, France

Location

1160.53.3303E Boehringer Ingelheim Investigational Site

Saint-Etienne, France

Location

1160.53.3303A Boehringer Ingelheim Investigational Site

Saint-Priest-en-Jarez, France

Location

1160.53.3311A Boehringer Ingelheim Investigational Site

Toulon Naval, France

Location

1160.53.3311B Boehringer Ingelheim Investigational Site

Toulon Naval, France

Location

1160.53.3311C Boehringer Ingelheim Investigational Site

Toulon Naval, France

Location

1160.53.3311D Boehringer Ingelheim Investigational Site

Toulon Naval, France

Location

1160.53.3311E Boehringer Ingelheim Investigational Site

Toulon Naval, France

Location

1160.53.3308A Boehringer Ingelheim Investigational Site

Vandœuvre-lès-Nancy, France

Location

1160.53.49003 Boehringer Ingelheim Investigational Site

Cologne, Germany

Location

1160.53.49017 Boehringer Ingelheim Investigational Site

Dresden, Germany

Location

1160.53.49018 Boehringer Ingelheim Investigational Site

Dresden, Germany

Location

1160.53.49005 Boehringer Ingelheim Investigational Site

Mannheim, Germany

Location

1160.53.49007 Boehringer Ingelheim Investigational Site

München, Germany

Location

1160.53.49009 Boehringer Ingelheim Investigational Site

Püttlingen, Germany

Location

1160.53.30001 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1160.53.30005 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1160.53.30006 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1160.53.36001 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

1160.53.36006 Boehringer Ingelheim Investigational Site

Budapest, Hungary

Location

1160.53.36002 Boehringer Ingelheim Investigational Site

Debrecen, Hungary

Location

1160.53.36013 Boehringer Ingelheim Investigational Site

Eger, Hungary

Location

1160.53.36012 Boehringer Ingelheim Investigational Site

Gyula, Hungary

Location

1160.53.36004 Boehringer Ingelheim Investigational Site

Miskolc, Hungary

Location

1160.53.36003 Boehringer Ingelheim Investigational Site

Pécs, Hungary

Location

1160.53.36010 Boehringer Ingelheim Investigational Site

Székesfehérvár, Hungary

Location

1160.53.36011 Boehringer Ingelheim Investigational Site

Szombathely, Hungary

Location

1160.53.91011 Boehringer Ingelheim Investigational Site

Bangalore, India

Location

1160.53.91012 Boehringer Ingelheim Investigational Site

Chennai, India

Location

1160.53.91019 Boehringer Ingelheim Investigational Site

Chennai, India

Location

1160.53.91013 Boehringer Ingelheim Investigational Site

Indore, India

Location

1160.53.91021 Boehringer Ingelheim Investigational Site

Karna, India

Location

1160.53.91022 Boehringer Ingelheim Investigational Site

Kerala, India

Location

1160.53.91020 Boehringer Ingelheim Investigational Site

Ludhiana, India

Location

1160.53.91007 Boehringer Ingelheim Investigational Site

Mysore, India

Location

1160.53.91015 Boehringer Ingelheim Investigational Site

Nagpur, India

Location

1160.53.91010 Boehringer Ingelheim Investigational Site

New Delhi, India

Location

1160.53.91005 Boehringer Ingelheim Investigational Site

Pune, India

Location

1160.53.91008 Boehringer Ingelheim Investigational Site

Pune, India

Location

1160.53.91004 Boehringer Ingelheim Investigational Site

Vadodara, India

Location

1160.53.97202 Boehringer Ingelheim Investigational Site

Afula, Israel

Location

1160.53.97207 Boehringer Ingelheim Investigational Site

Ashkelon, Israel

Location

1160.53.97211 Boehringer Ingelheim Investigational Site

Haifa, Israel

Location

1160.53.97203 Boehringer Ingelheim Investigational Site

Holon, Israel

Location

1160.53.97205 Boehringer Ingelheim Investigational Site

KfarSaba, Israel

Location

1160.53.97206 Boehringer Ingelheim Investigational Site

Petah Tikva, Israel

Location

1160.53.97210 Boehringer Ingelheim Investigational Site

Tel Aviv, Israel

Location

1160.53.97204 Boehringer Ingelheim Investigational Site

Tel Litwinsky, Israel

Location

1160.53.97201 Boehringer Ingelheim Investigational Site

Ẕerifin, Israel

Location

1160.53.39003 Boehringer Ingelheim Investigational Site

Bologna, Italy

Location

1160.53.39002 Boehringer Ingelheim Investigational Site

Padua, Italy

Location

1160.53.39001 Boehringer Ingelheim Investigational Site

Perugia, Italy

Location

1160.53.39004 Boehringer Ingelheim Investigational Site

Reggio Emilia, Italy

Location

1160.53.39007 Boehringer Ingelheim Investigational Site

Vimercate, Italy

Location

1160.53.39005 Boehringer Ingelheim Investigational Site

Vittorio Veneto (tv), Italy

Location

1160.53.5264 Boehringer Ingelheim Investigational Site

Chihuahua City, Mexico

Location

1160.53.5270 Boehringer Ingelheim Investigational Site

Culiacán, Mexico

Location

1160.53.5262 Boehringer Ingelheim Investigational Site

San Luis Potosí City, Mexico

Location

1160.53.31010 Boehringer Ingelheim Investigational Site

's-Hertogenbosch, Netherlands

Location

1160.53.31001 Boehringer Ingelheim Investigational Site

Amersfoort, Netherlands

Location

1160.53.31006 Boehringer Ingelheim Investigational Site

Amsterdam, Netherlands

Location

1160.53.31013 Boehringer Ingelheim Investigational Site

Eindhoven, Netherlands

Location

1160.53.31005 Boehringer Ingelheim Investigational Site

Maastricht, Netherlands

Location

1160.53.31002 Boehringer Ingelheim Investigational Site

Nieuwegein, Netherlands

Location

1160.53.31004 Boehringer Ingelheim Investigational Site

Rotterdam, Netherlands

Location

1160.53.31009 Boehringer Ingelheim Investigational Site

Rotterdam, Netherlands

Location

1160.53.64003 Boehringer Ingelheim Investigational Site

Auckland, New Zealand

Location

1160.53.64004 Boehringer Ingelheim Investigational Site

Christchurch, New Zealand

Location

1160.53.64002 Boehringer Ingelheim Investigational Site

Otahuhu Auckland, New Zealand

Location

1160.53.64001 Boehringer Ingelheim Investigational Site

Takapuna Auckland, New Zealand

Location

1160.53.47001 Boehringer Ingelheim Investigational Site

Oslo, Norway

Location

1160.53.47004 Boehringer Ingelheim Investigational Site

Oslo, Norway

Location

1160.53.47003 Boehringer Ingelheim Investigational Site

Rud, Norway

Location

1160.53.47005 Boehringer Ingelheim Investigational Site

Trondheim, Norway

Location

1160.53.35104 Boehringer Ingelheim Investigational Site

Almada, Portugal

Location

1160.53.35109 Boehringer Ingelheim Investigational Site

Coimbra, Portugal

Location

1160.53.35101 Boehringer Ingelheim Investigational Site

Lisbon, Portugal

Location

1160.53.35102 Boehringer Ingelheim Investigational Site

Lisbon, Portugal

Location

1160.53.35105 Boehringer Ingelheim Investigational Site

Lisbon, Portugal

Location

1160.53.07011 Boehringer Ingelheim Investigational Site

Chelyabinsk, Russia

Location

1160.53.07021 Boehringer Ingelheim Investigational Site

Chelyabinsk, Russia

Location

1160.53.07016 Boehringer Ingelheim Investigational Site

Krasnodar, Russia

Location

1160.53.07004 Boehringer Ingelheim Investigational Site

Kursk, Russia

Location

1160.53.07003 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1160.53.07010 Boehringer Ingelheim Investigational Site

Novosibirsk, Russia

Location

1160.53.07020 Boehringer Ingelheim Investigational Site

Omsk, Russia

Location

1160.53.07018 Boehringer Ingelheim Investigational Site

Pskov, Russia

Location

1160.53.07009 Boehringer Ingelheim Investigational Site

Rostov-on-Don, Russia

Location

1160.53.07023 Boehringer Ingelheim Investigational Site

Rostov-on-Don, Russia

Location

1160.53.07024 Boehringer Ingelheim Investigational Site

Rostov-on-Don, Russia

Location

1160.53.07025 Boehringer Ingelheim Investigational Site

Rostov-on-Don, Russia

Location

1160.53.07001 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1160.53.07014 Boehringer Ingelheim Investigational Site

Ufa, Russia

Location

1160.53.07005 Boehringer Ingelheim Investigational Site

Yaroslavl, Russia

Location

1160.53.07006 Boehringer Ingelheim Investigational Site

Yaroslavl, Russia

Location

1160.53.07007 Boehringer Ingelheim Investigational Site

Yekaterinburg, Russia

Location

1160.53.42107 Boehringer Ingelheim Investigational Site

Banská Bystrica, Slovakia

Location

1160.53.42106 Boehringer Ingelheim Investigational Site

Lučenec, Slovakia

Location

1160.53.42102 Boehringer Ingelheim Investigational Site

Nitra, Slovakia

Location

1160.53.42103 Boehringer Ingelheim Investigational Site

Nové Zámky, Slovakia

Location

1160.53.42104 Boehringer Ingelheim Investigational Site

Žilina, Slovakia

Location

1160.53.27007 Boehringer Ingelheim Investigational Site

Centurion, South Africa

Location

1160.53.27001 Boehringer Ingelheim Investigational Site

Johannesburg, South Africa

Location

1160.53.27002 Boehringer Ingelheim Investigational Site

Johannesburg, South Africa

Location

1160.53.27004 Boehringer Ingelheim Investigational Site

Johannesburg, South Africa

Location

1160.53.27006 Boehringer Ingelheim Investigational Site

Johannesburg, South Africa

Location

1160.53.27009 Suite 404, Medical Centre

Pretoria, South Africa

Location

1160.53.27003 Boehringer Ingelheim Investigational Site

Randburg, South Africa

Location

1160.53.27008 Suite M5, Second Floor

Richards Bay, South Africa

Location

1160.53.27005 Boehringer Ingelheim Investigational Site

Roodepoort, South Africa

Location

1160.53.34012 Boehringer Ingelheim Investigational Site

Badalona (Barcelona), Spain

Location

1160.53.34001 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1160.53.34002 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1160.53.34007 Boehringer Ingelheim Investigational Site

Cartagena. Murcia, Spain

Location

1160.53.34003 Boehringer Ingelheim Investigational Site

Cuenca, Spain

Location

1160.53.34009 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1160.53.34010 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1160.53.34004 Boehringer Ingelheim Investigational Site

Santander, Spain

Location

1160.53.34005 Boehringer Ingelheim Investigational Site

Torrelavega.Santander, Spain

Location

1160.53.34011 Boehringer Ingelheim Investigational Site

Valencia, Spain

Location

1160.53.46002 Boehringer Ingelheim Investigational Site

Gothenburg, Sweden

Location

1160.53.46006 Boehringer Ingelheim Investigational Site

Jönköping, Sweden

Location

1160.53.46001 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

1160.53.46007 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

1160.53.46008 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

1160.53.46005 Boehringer Ingelheim Investigational Site

Sundsvall, Sweden

Location

1160.53.46003 Boehringer Ingelheim Investigational Site

Uppsala, Sweden

Location

1160.53.90003 Boehringer Ingelheim Investigational Site

Ankara, Turkey (Türkiye)

Location

1160.53.90004 Boehringer Ingelheim Investigational Site

Ankara, Turkey (Türkiye)

Location

1160.53.90005 Boehringer Ingelheim Investigational Site

Ankara, Turkey (Türkiye)

Location

1160.53.90001 Boehringer Ingelheim Investigational Site

Istanbul, Turkey (Türkiye)

Location

1160.53.90002 Boehringer Ingelheim Investigational Site

Istanbul, Turkey (Türkiye)

Location

1160.53.90007 Boehringer Ingelheim Investigational Site

Istanbul, Turkey (Türkiye)

Location

1160.53.90006 Boehringer Ingelheim Investigational Site

Izmir, Turkey (Türkiye)

Location

1160.53.38006 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1160.53.38005 Boehringer Ingelheim Investigational Site

Vinnitsa, Ukraine

Location

1160.53.38003 Boehringer Ingelheim Investigational Site

Zaporizhzhya, Ukraine

Location

1160.53.44008 Boehringer Ingelheim Investigational Site

Aberdeen, United Kingdom

Location

1160.53.44005 Boehringer Ingelheim Investigational Site

Headington, Oxford, United Kingdom

Location

1160.53.44004 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1160.53.44009 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1160.53.44011 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1160.53.44006 Boehringer Ingelheim Investigational Site

Newcastle upon Tyne, United Kingdom

Location

1160.53.44012 Boehringer Ingelheim Investigational Site

Sheffield, United Kingdom

Location

Related Publications (4)

• 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

• 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.

  PMID: 24344086 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, 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.

  PMID: 19966341 DERIVED

Related Links

• Related Info

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

Study Record Dates

• First Submitted: February 13, 2006
• First Posted: February 14, 2006
• Study Start: February 1, 2006
• Primary Completion: May 1, 2009
• Last Updated: June 6, 2014
• Results First Posted: February 11, 2011

Record last verified: 2014-04

Locations

DK (6); RU (17); NO (4); GR (3); IN (13); CA (18); SL (5); BE (6); UA (3); PT (5); ZA (9); GB (7); TU (7); BR (11); AU (6); US (23); NZ (4); FR (24); CZ (12); DE (6); ME (3); AR (6); SE (7); IT (6); ES (10); HU (9); IL (9); NL (8)