AzTrials
AzTrials

ThromboembolismPhase 3RE-COVER INCT00291330

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

A Phase 3 study testing dabigatran etexilate 150 mg and warfarin (INR 2-3) in people with Thromboembolism, run by Boehringer Ingelheim at 250 sites in 29 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thromboembolism
What is being tested?
dabigatran etexilate 150 mg and warfarin (INR 2-3)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,564 participants
Where
250 sitesin 29 countries
Study dates
Feb 2006to May 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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
  • Participation in another clinical trial with an investigational drug during the last 30 days or previous participation in this study
  • Patients considered unsuitable for inclusion by the investigator

Trial locations and contacts

250 sites in 29 countries.

250 sites in 29 countries

France24 sites

  • 1160.53.3301A Boehringer Ingelheim Investigational Site

    Brest

  • 1160.53.3301B Boehringer Ingelheim Investigational Site

    Brest

  • 1160.53.3301C Boehringer Ingelheim Investigational Site

    Brest

  • 1160.53.3301D Boehringer Ingelheim Investigational Site

    Brest

  • 1160.53.3301E Boehringer Ingelheim Investigational Site

    Brest

  • 1160.53.3301F Boehringer Ingelheim Investigational Site

    Brest

  • 1160.53.3301H Boehringer Ingelheim Investigational Site

    Brest

  • 1160.53.3301I Boehringer Ingelheim Investigational Site

    Brest

  • 1160.53.3302A Boehringer Ingelheim Investigational Site

    Lorient

  • 1160.53.3310A Boehringer Ingelheim Investigational Site

    Montpellier

  • 1160.53.3310B Boehringer Ingelheim Investigational Site

    Montpellier

  • 1160.53.3310C Boehringer Ingelheim Investigational Site

    Montpellier

  • 1160.53.3308B Boehringer Ingelheim Investigational Site

    Nancy

  • 1160.53.3303B Boehringer Ingelheim Investigational Site

    Saint-Etienne

  • 1160.53.3303C Boehringer Ingelheim Investigational Site

    Saint-Etienne

  • 1160.53.3303D Boehringer Ingelheim Investigational Site

    Saint-Etienne

  • 1160.53.3303E Boehringer Ingelheim Investigational Site

    Saint-Etienne

  • 1160.53.3303A Boehringer Ingelheim Investigational Site

    Saint-Priest-en-Jarez

  • 1160.53.3311A Boehringer Ingelheim Investigational Site

    Toulon Naval

  • 1160.53.3311B Boehringer Ingelheim Investigational Site

    Toulon Naval

  • 1160.53.3311C Boehringer Ingelheim Investigational Site

    Toulon Naval

  • 1160.53.3311D Boehringer Ingelheim Investigational Site

    Toulon Naval

  • 1160.53.3311E Boehringer Ingelheim Investigational Site

    Toulon Naval

  • 1160.53.3308A Boehringer Ingelheim Investigational Site

    Vandœuvre-lès-Nancy

Other trials in France

United States23 sites

  • 1160.53.01036 Boehringer Ingelheim Investigational Site

    Albuquerque, New Mexico

  • 1160.53.01052 Boehringer Ingelheim Investigational Site

    Altoona, Pennsylvania

  • 1160.53.01019 Boehringer Ingelheim Investigational Site

    Augusta, Georgia

  • 1160.53.01014 Boehringer Ingelheim Investigational Site

    Baltimore, Maryland

  • 1160.53.01027 Boehringer Ingelheim Investigational Site

    Chapel Hill, North Carolina

  • 1160.53.01044 Boehringer Ingelheim Investigational Site

    Clearwater, Florida

  • 1160.53.01008 Boehringer Ingelheim Investigational Site

    Decatur, Georgia

  • 1160.53.01023 Boehringer Ingelheim Investigational Site

    Detroit, Michigan

  • 1160.53.01030 Boehringer Ingelheim Investigational Site

    Grand Forks, North Dakota

  • 1160.53.01056 Boehringer Ingelheim Investigational Site

    Hartford, Connecticut

  • 1160.53.01031 Boehringer Ingelheim Investigational Site

    Lebanon, New Hampshire

  • 1160.53.01010 Boehringer Ingelheim Investigational Site

    Marietta, Georgia

  • 1160.53.01035 Boehringer Ingelheim Investigational Site

    Mobile, Alabama

  • 1160.53.01029 Boehringer Ingelheim Investigational Site

    Pontiac, Michigan

  • 1160.53.01028 Boehringer Ingelheim Investigational Site

    Portland, Oregon

  • 1160.53.01017 Boehringer Ingelheim Investigational Site

    Richmond, Virginia

  • 1160.53.01009 Boehringer Ingelheim Investigational Site

    Saint Louis Park, Minnesota

  • 1160.53.01033 Boehringer Ingelheim Investigational Site

    Sarasota, Florida

  • 1160.53.01046 Boehringer Ingelheim Investigational Site

    Sarasota, Florida

  • 1160.53.01055 Boehringer Ingelheim Investigational Site

    Summerville, South Carolina

  • 1160.53.01013 Boehringer Ingelheim Investigational Site

    Toledo, Ohio

  • 1160.53.01025 Boehringer Ingelheim Investigational Site

    Valhalla, New York

  • 1160.53.01039 Boehringer Ingelheim Investigational Site

    Winston-Salem, North Carolina

Other trials in United States

Canada18 sites

  • 1160.53.02006 Boehringer Ingelheim Investigational Site

    Edmonton, Alberta

  • 1160.53.02013 Boehringer Ingelheim Investigational Site

    Edmonton, Alberta

  • 1160.53.02001 Boehringer Ingelheim Investigational Site

    Halifax, Nova Scotia

  • 1160.53.02002 Boehringer Ingelheim Investigational Site

    Hamilton, Ontario

  • 1160.53.02005 Boehringer Ingelheim Investigational Site

    Hamilton, Ontario

  • 1160.53.02010 Boehringer Ingelheim Investigational Site

    Hamilton, Ontario

  • 1160.53.02022 Boehringer Ingelheim Investigational Site

    Hamilton, Ontario

  • 1160.53.02011 Boehringer Ingelheim Investigational Site

    London, Ontario

  • 1160.53.02008 Boehringer Ingelheim Investigational Site

    Montreal, Quebec

  • 1160.53.02009 Boehringer Ingelheim Investigational Site

    Montreal, Quebec

  • 1160.53.02014 Boehringer Ingelheim Investigational Site

    Montreal, Quebec

  • 1160.53.02017 Boehringer Ingelheim Investigational Site

    Montreal, Quebec

  • 1160.53.02015 Boehringer Ingelheim Investigational Site

    Ottawa, Ontario

  • 1160.53.02020 Boehringer Ingelheim Investigational Site

    Québec, Quebec

  • 1160.53.02004 Boehringer Ingelheim Investigational Site

    Saint Johns, New Brunswick

  • 1160.53.02003 Boehringer Ingelheim Investigational Site

    Sainte-Foy, Quebec

  • 1160.53.02019 Boehringer Ingelheim Investigational Site

    Toronto, Ontario

  • 1160.53.02021 Boehringer Ingelheim Investigational Site

    Victoria, British Columbia

Other trials in Canada

Russia17 sites

  • 1160.53.07011 Boehringer Ingelheim Investigational Site

    Chelyabinsk

  • 1160.53.07021 Boehringer Ingelheim Investigational Site

    Chelyabinsk

  • 1160.53.07016 Boehringer Ingelheim Investigational Site

    Krasnodar

  • 1160.53.07004 Boehringer Ingelheim Investigational Site

    Kursk

  • 1160.53.07003 Boehringer Ingelheim Investigational Site

    Moscow

  • 1160.53.07010 Boehringer Ingelheim Investigational Site

    Novosibirsk

  • 1160.53.07020 Boehringer Ingelheim Investigational Site

    Omsk

  • 1160.53.07018 Boehringer Ingelheim Investigational Site

    Pskov

  • 1160.53.07009 Boehringer Ingelheim Investigational Site

    Rostov-on-Don

  • 1160.53.07023 Boehringer Ingelheim Investigational Site

    Rostov-on-Don

  • 1160.53.07024 Boehringer Ingelheim Investigational Site

    Rostov-on-Don

  • 1160.53.07025 Boehringer Ingelheim Investigational Site

    Rostov-on-Don

  • 1160.53.07001 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 1160.53.07014 Boehringer Ingelheim Investigational Site

    Ufa

  • 1160.53.07005 Boehringer Ingelheim Investigational Site

    Yaroslavl

  • 1160.53.07006 Boehringer Ingelheim Investigational Site

    Yaroslavl

  • 1160.53.07007 Boehringer Ingelheim Investigational Site

    Yekaterinburg

Other trials in Russia

India13 sites

  • 1160.53.91011 Boehringer Ingelheim Investigational Site

    Bangalore

  • 1160.53.91012 Boehringer Ingelheim Investigational Site

    Chennai

  • 1160.53.91019 Boehringer Ingelheim Investigational Site

    Chennai

  • 1160.53.91013 Boehringer Ingelheim Investigational Site

    Indore

  • 1160.53.91021 Boehringer Ingelheim Investigational Site

    Karna

  • 1160.53.91022 Boehringer Ingelheim Investigational Site

    Kerala

  • 1160.53.91020 Boehringer Ingelheim Investigational Site

    Ludhiana

  • 1160.53.91007 Boehringer Ingelheim Investigational Site

    Mysore

  • 1160.53.91015 Boehringer Ingelheim Investigational Site

    Nagpur

  • 1160.53.91010 Boehringer Ingelheim Investigational Site

    New Delhi

  • 1160.53.91005 Boehringer Ingelheim Investigational Site

    Pune

  • 1160.53.91008 Boehringer Ingelheim Investigational Site

    Pune

  • 1160.53.91004 Boehringer Ingelheim Investigational Site

    Vadodara

Other trials in India

Czechia12 sites

  • 1160.53.42001 Boehringer Ingelheim Investigational Site

    Brno

  • 1160.53.42002 Boehringer Ingelheim Investigational Site

    Hradec Králové

  • 1160.53.42011 Boehringer Ingelheim Investigational Site

    Hranice

  • 1160.53.42009 Boehringer Ingelheim Investigational Site

    Jihlava

  • 1160.53.42012 Boehringer Ingelheim Investigational Site

    Liberec

  • 1160.53.42015 Boehringer Ingelheim Investigational Site

    Nový Jičín

  • 1160.53.42005 Boehringer Ingelheim Investigational Site

    Ostrava-Vitkovice

  • 1160.53.42004 Boehringer Ingelheim Investigational Site

    Prague

  • 1160.53.42014 Boehringer Ingelheim Investigational Site

    Tábor

  • 1160.53.42016 Boehringer Ingelheim Investigational Site

    Teplice

  • 1160.53.42010 Boehringer Ingelheim Investigational Site

    Ústí nad Labem

  • 1160.53.42007 Boehringer Ingelheim Investigational Site

    Zlín

Other trials in Czechia

Brazil11 sites

  • 1160.53.55010 Boehringer Ingelheim Investigational Site

    Brasília

  • 1160.53.55007 Boehringer Ingelheim Investigational Site

    Campinas

  • 1160.53.55001 Boehringer Ingelheim Investigational Site

    Cerqueira César - Sao Paulo

  • 1160.53.55002 Boehringer Ingelheim Investigational Site

    Cerqueira César - São Paulo

  • 1160.53.55014 Boehringer Ingelheim Investigational Site

    Cristo Rei - Curitiba

  • 1160.53.55011 Boehringer Ingelheim Investigational Site

    Goiânia

  • 1160.53.55017 Boehringer Ingelheim Investigational Site

    Paraná

  • 1160.53.55012 Boehringer Ingelheim Investigational Site

    Porto Alegre

  • 1160.53.55016 Boehringer Ingelheim Investigational Site

    Rio de Janeiro - RJ

  • 1160.53.55004 Boehringer Ingelheim Investigational Site

    Santo André

  • 1160.53.55005 Boehringer Ingelheim Investigational Site

    São José do Rio Preto

Other trials in Brazil

Spain10 sites

  • 1160.53.34012 Boehringer Ingelheim Investigational Site

    Badalona (Barcelona)

  • 1160.53.34001 Boehringer Ingelheim Investigational Site

    Barcelona

  • 1160.53.34002 Boehringer Ingelheim Investigational Site

    Barcelona

  • 1160.53.34007 Boehringer Ingelheim Investigational Site

    Cartagena. Murcia

  • 1160.53.34003 Boehringer Ingelheim Investigational Site

    Cuenca

  • 1160.53.34009 Boehringer Ingelheim Investigational Site

    Madrid

  • 1160.53.34010 Boehringer Ingelheim Investigational Site

    Madrid

  • 1160.53.34004 Boehringer Ingelheim Investigational Site

    Santander

  • 1160.53.34005 Boehringer Ingelheim Investigational Site

    Torrelavega.Santander

  • 1160.53.34011 Boehringer Ingelheim Investigational Site

    Valencia

Other trials in Spain

Hungary9 sites

  • 1160.53.36001 Boehringer Ingelheim Investigational Site

    Budapest

  • 1160.53.36006 Boehringer Ingelheim Investigational Site

    Budapest

  • 1160.53.36002 Boehringer Ingelheim Investigational Site

    Debrecen

  • 1160.53.36013 Boehringer Ingelheim Investigational Site

    Eger

  • 1160.53.36012 Boehringer Ingelheim Investigational Site

    Gyula

  • 1160.53.36004 Boehringer Ingelheim Investigational Site

    Miskolc

  • 1160.53.36003 Boehringer Ingelheim Investigational Site

    Pécs

  • 1160.53.36010 Boehringer Ingelheim Investigational Site

    Székesfehérvár

  • 1160.53.36011 Boehringer Ingelheim Investigational Site

    Szombathely

Other trials in Hungary

Israel9 sites

  • 1160.53.97202 Boehringer Ingelheim Investigational Site

    Afula

  • 1160.53.97207 Boehringer Ingelheim Investigational Site

    Ashkelon

  • 1160.53.97211 Boehringer Ingelheim Investigational Site

    Haifa

  • 1160.53.97203 Boehringer Ingelheim Investigational Site

    Holon

  • 1160.53.97205 Boehringer Ingelheim Investigational Site

    KfarSaba

  • 1160.53.97206 Boehringer Ingelheim Investigational Site

    Petah Tikva

  • 1160.53.97210 Boehringer Ingelheim Investigational Site

    Tel Aviv

  • 1160.53.97204 Boehringer Ingelheim Investigational Site

    Tel HaShomer

  • 1160.53.97201 Boehringer Ingelheim Investigational Site

    Tsrifin

Other trials in Israel

South Africa9 sites

  • 1160.53.27007 Boehringer Ingelheim Investigational Site

    Centurion

  • 1160.53.27001 Boehringer Ingelheim Investigational Site

    Johannesburg

  • 1160.53.27002 Boehringer Ingelheim Investigational Site

    Johannesburg

  • 1160.53.27004 Boehringer Ingelheim Investigational Site

    Johannesburg

  • 1160.53.27006 Boehringer Ingelheim Investigational Site

    Johannesburg

  • 1160.53.27009 Suite 404, Medical Centre

    Pretoria

  • 1160.53.27003 Boehringer Ingelheim Investigational Site

    Randburg

  • 1160.53.27008 Suite M5, Second Floor

    Richards Bay

  • 1160.53.27005 Boehringer Ingelheim Investigational Site

    Roodepoort

Other trials in South Africa

Netherlands8 sites

  • 1160.53.31010 Boehringer Ingelheim Investigational Site

    's-Hertogenbosch

  • 1160.53.31001 Boehringer Ingelheim Investigational Site

    Amersfoort

  • 1160.53.31006 Boehringer Ingelheim Investigational Site

    Amsterdam

  • 1160.53.31013 Boehringer Ingelheim Investigational Site

    Eindhoven

  • 1160.53.31005 Boehringer Ingelheim Investigational Site

    Maastricht

  • 1160.53.31002 Boehringer Ingelheim Investigational Site

    Nieuwegein

  • 1160.53.31004 Boehringer Ingelheim Investigational Site

    Rotterdam

  • 1160.53.31009 Boehringer Ingelheim Investigational Site

    Rotterdam

Other trials in Netherlands

Sweden7 sites

  • 1160.53.46002 Boehringer Ingelheim Investigational Site

    Gothenburg

  • 1160.53.46006 Boehringer Ingelheim Investigational Site

    Jönköping

  • 1160.53.46001 Boehringer Ingelheim Investigational Site

    Stockholm

  • 1160.53.46007 Boehringer Ingelheim Investigational Site

    Stockholm

  • 1160.53.46008 Boehringer Ingelheim Investigational Site

    Stockholm

  • 1160.53.46005 Boehringer Ingelheim Investigational Site

    Sundsvall

  • 1160.53.46003 Boehringer Ingelheim Investigational Site

    Uppsala

Other trials in Sweden

Turkey (Türkiye)7 sites

  • 1160.53.90003 Boehringer Ingelheim Investigational Site

    Ankara

  • 1160.53.90004 Boehringer Ingelheim Investigational Site

    Ankara

  • 1160.53.90005 Boehringer Ingelheim Investigational Site

    Ankara

  • 1160.53.90001 Boehringer Ingelheim Investigational Site

    Istanbul

  • 1160.53.90002 Boehringer Ingelheim Investigational Site

    Istanbul

  • 1160.53.90007 Boehringer Ingelheim Investigational Site

    Istanbul

  • 1160.53.90006 Boehringer Ingelheim Investigational Site

    Izmir

Other trials in Turkey (Türkiye)

United Kingdom7 sites

  • 1160.53.44008 Boehringer Ingelheim Investigational Site

    Aberdeen

  • 1160.53.44005 Boehringer Ingelheim Investigational Site

    Headington, Oxford

  • 1160.53.44004 Boehringer Ingelheim Investigational Site

    London

  • 1160.53.44009 Boehringer Ingelheim Investigational Site

    London

  • 1160.53.44011 Boehringer Ingelheim Investigational Site

    London

  • 1160.53.44006 Boehringer Ingelheim Investigational Site

    Newcastle upon Tyne

  • 1160.53.44012 Boehringer Ingelheim Investigational Site

    Sheffield

Other trials in United Kingdom

Argentina6 sites

  • 1160.53.54017 Boehringer Ingelheim Investigational Site

    Adrogué

  • 1160.53.54003 Boehringer Ingelheim Investigational Site

    Capital Federal

  • 1160.53.54005 Boehringer Ingelheim Investigational Site

    Capital Federal

  • 1160.53.54006 Boehringer Ingelheim Investigational Site

    Capital Federal

  • 1160.53.54007 Boehringer Ingelheim Investigational Site

    Capital Federal

  • 1160.53.54010 Boehringer Ingelheim Investigational Site

    Capital Federal

Other trials in Argentina

Australia6 sites

  • 1160.53.61004 Boehringer Ingelheim Investigational Site

    Bedford Park, South Australia

  • 1160.53.61003 Boehringer Ingelheim Investigational Site

    Box Hill, Victoria

  • 1160.53.61001 Boehringer Ingelheim Investigational Site

    Clayton, Victoria

  • 1160.53.61005 Boehringer Ingelheim Investigational Site

    Perth, Western Australia

  • 1160.53.61006 The Avenue Cardiovascular Centre

    Windsor, Victoria

  • 1160.53.61002 Boehringer Ingelheim Investigational Site

    Woolloongabba, Queensland

Other trials in Australia

Belgium6 sites

  • 1160.53.32001 Boehringer Ingelheim Investigational Site

    Brussels

  • 1160.53.32002 Boehringer Ingelheim Investigational Site

    Brussels

  • 1160.53.32003 Boehringer Ingelheim Investigational Site

    Brussels

  • 1160.53.32007 Boehringer Ingelheim Investigational Site

    Edegem

  • 1160.53.32005 Boehringer Ingelheim Investigational Site

    Leuven

  • 1160.53.32004 Boehringer Ingelheim Investigational Site

    Liège

Other trials in Belgium

Denmark6 sites

  • 1160.53.45008 Boehringer Ingelheim Investigational Site

    Esbjerg

  • 1160.53.45009 Boehringer Ingelheim Investigational Site

    Holbæk

  • 1160.53.45004 Boehringer Ingelheim Investigational Site

    København NV

  • 1160.53.45007 Boehringer Ingelheim Investigational Site

    København S

  • 1160.53.45002 Boehringer Ingelheim Investigational Site

    Kolding

  • 1160.53.45006 Boehringer Ingelheim Investigational Site

    Slagelse

Other trials in Denmark

Germany6 sites

  • 1160.53.49003 Boehringer Ingelheim Investigational Site

    Cologne

  • 1160.53.49017 Boehringer Ingelheim Investigational Site

    Dresden

  • 1160.53.49018 Boehringer Ingelheim Investigational Site

    Dresden

  • 1160.53.49005 Boehringer Ingelheim Investigational Site

    Mannheim

  • 1160.53.49007 Boehringer Ingelheim Investigational Site

    München

  • 1160.53.49009 Boehringer Ingelheim Investigational Site

    Püttlingen

Other trials in Germany

Italy6 sites

  • 1160.53.39003 Boehringer Ingelheim Investigational Site

    Bologna

  • 1160.53.39002 Boehringer Ingelheim Investigational Site

    Padova

  • 1160.53.39001 Boehringer Ingelheim Investigational Site

    Perugia

  • 1160.53.39004 Boehringer Ingelheim Investigational Site

    Reggio Emilia

  • 1160.53.39007 Boehringer Ingelheim Investigational Site

    Vimercate

  • 1160.53.39005 Boehringer Ingelheim Investigational Site

    Vittorio Veneto (tv)

Other trials in Italy

Portugal5 sites

  • 1160.53.35104 Boehringer Ingelheim Investigational Site

    Almada

  • 1160.53.35109 Boehringer Ingelheim Investigational Site

    Coimbra

  • 1160.53.35101 Boehringer Ingelheim Investigational Site

    Lisbon

  • 1160.53.35102 Boehringer Ingelheim Investigational Site

    Lisbon

  • 1160.53.35105 Boehringer Ingelheim Investigational Site

    Lisbon

Other trials in Portugal

Slovakia5 sites

  • 1160.53.42107 Boehringer Ingelheim Investigational Site

    Banská Bystrica

  • 1160.53.42106 Boehringer Ingelheim Investigational Site

    Lučenec

  • 1160.53.42102 Boehringer Ingelheim Investigational Site

    Nitra

  • 1160.53.42103 Boehringer Ingelheim Investigational Site

    Nové Zámky

  • 1160.53.42104 Boehringer Ingelheim Investigational Site

    Žilina

Other trials in Slovakia

New Zealand4 sites

  • 1160.53.64003 Boehringer Ingelheim Investigational Site

    Auckland

  • 1160.53.64004 Boehringer Ingelheim Investigational Site

    Christchurch

  • 1160.53.64002 Boehringer Ingelheim Investigational Site

    Otahuhu Auckland

  • 1160.53.64001 Boehringer Ingelheim Investigational Site

    Takapuna Auckland

Other trials in New Zealand

Norway4 sites

  • 1160.53.47001 Boehringer Ingelheim Investigational Site

    Oslo

  • 1160.53.47004 Boehringer Ingelheim Investigational Site

    Oslo

  • 1160.53.47003 Boehringer Ingelheim Investigational Site

    Rud

  • 1160.53.47005 Boehringer Ingelheim Investigational Site

    Trondheim

Other trials in Norway

Austria3 sites

  • 1160.53.43001 Boehringer Ingelheim Investigational Site

    Graz

  • 1160.53.43003 Boehringer Ingelheim Investigational Site

    Innsbruck

  • 1160.53.43002 Boehringer Ingelheim Investigational Site

    Vienna

Other trials in Austria

Greece3 sites

  • 1160.53.30001 Boehringer Ingelheim Investigational Site

    Athens

  • 1160.53.30005 Boehringer Ingelheim Investigational Site

    Athens

  • 1160.53.30006 Boehringer Ingelheim Investigational Site

    Athens

Other trials in Greece

Mexico3 sites

  • 1160.53.5264 Boehringer Ingelheim Investigational Site

    Chihuahua City

  • 1160.53.5270 Boehringer Ingelheim Investigational Site

    Culiacán

  • 1160.53.5262 Boehringer Ingelheim Investigational Site

    San Luis Potosí City

Other trials in Mexico

Ukraine3 sites

  • 1160.53.38006 Boehringer Ingelheim Investigational Site

    Kiev

  • 1160.53.38005 Boehringer Ingelheim Investigational Site

    Vinnitsa

  • 1160.53.38003 Boehringer Ingelheim Investigational Site

    Zaporizhzhya

Other trials in Ukraine

About this study

Official title: 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.

Conditions
Thromboembolism
Being tested
dabigatran etexilate 150 mg, warfarin (INR 2-3)
Medical subject headings
Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dabigatran etexilate 150 mgDrug

    twice daily

  • warfarin (INR 2-3)Drug

    prn to maintain INR (2-3)

Study groups in NCT00291330
Study groupRoleWhat they receive
dabigatran etexilate 150 mgExperimentaltwice daily
Receives: Drug: dabigatran etexilate 150 mg
warfarin (INR 2-3)Active comparatorprn to maintain INR (2-3)
Receives: Drug: warfarin (INR 2-3)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. 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.

    Measured: 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.

  2. 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.

    Measured: 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.

  3. 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.

    Measured: 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.

  4. 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.

    Measured: 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.

  5. 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.

    Measured: 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.

  6. 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.

    Measured: 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)

  7. 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.

    Measured: From first intake of study drug to end of study conduct

  8. Laboratory Analyses

    Frequency of patients with possible clinically significant abnormalities.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2006 (estimated)
  2. Study startFeb 2006
  3. Primary completionMay 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
2,564 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00291330
Sponsor's protocol ID
1160.53
Other IDs
2005-001999-12, 2005
Acronym
RE-COVER I
Status last verified
Apr 2014
First submitted
13 Feb 2006
Last updated
6 Jun 2014

Publications

  • 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.

    PubMed 27807306

  • 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.

    PubMed 24344086

  • 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.

    PubMed 24081972

  • 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.

    PubMed 19966341

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing dabigatran etexilate 150 mg and warfarin (INR 2-3) in people with Thromboembolism, run by Boehringer Ingelheim at 250 sites in 29 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 250 sites in France, United States, Canada, Russia, India and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE (time frame: 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00291330, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2014.

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