AzTrials
AzTrials

ThromboembolismPhase 3RE-MEDYNCT00329238

Secondary Prevention of Venous Thrombo Embolism (VTE).

A Phase 3 study testing Dabigatran and Warfarin in people with Thromboembolism, run by Boehringer Ingelheim at 275 sites in 33 countries.

Completed

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

Official record
Search all trials

Trial 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… 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 and Warfarin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,867 participants
Where
275 sitesin 33 countries
Study dates
May 2006to Oct 2010
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

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

Who cannot join

  • ExclusionCriteria
  • 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)

Trial locations and contacts

275 sites in 33 countries.

275 sites in 33 countries

Russia20 sites

  • 1160.47.07022 Boehringer Ingelheim Investigational Site

    Belgorod

  • 1160.47.07011 Boehringer Ingelheim Investigational Site

    Chelyabinsk

  • 1160.47.07021 Boehringer Ingelheim Investigational Site

    Chelyabinsk

  • 1160.47.07016 Boehringer Ingelheim Investigational Site

    Krasnodar

  • 1160.47.07004 Boehringer Ingelheim Investigational Site

    Kursk

  • 1160.47.07010 Boehringer Ingelheim Investigational Site

    Novosibirsk

  • 1160.47.07020 Boehringer Ingelheim Investigational Site

    Omsk

  • 1160.47.07018 Boehringer Ingelheim Investigational Site

    Pskov

  • 1160.47.07009 Boehringer Ingelheim Investigational Site

    Rostov-on-Don

  • 1160.47.07023 Boehringer Ingelheim Investigational Site

    Rostov-on-Don

  • 1160.47.07024 Boehringer Ingelheim Investigational Site

    Rostov-on-Don

  • 1160.47.07025 Boehringer Ingelheim Investigational Site

    Rostov-on-Don

  • 1160.47.07001 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 1160.47.07002 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 1160.47.07017 Boehringer Ingelheim Investigational Site

    Saint Petersburg

  • 1160.47.07019 Boehringer Ingelheim Investigational Site

    Tyumen

  • 1160.47.07014 Boehringer Ingelheim Investigational Site

    Ufa

  • 1160.47.07005 Boehringer Ingelheim Investigational Site

    Yaroslavl

  • 1160.47.07006 Boehringer Ingelheim Investigational Site

    Yaroslavl

  • 1160.47.07007 Boehringer Ingelheim Investigational Site

    Yekaterinburg

Other trials in Russia

United States18 sites

  • 1160.47.01036 Boehringer Ingelheim Investigational Site

    Albuquerque, New Mexico

  • 1160.47.01052 Boehringer Ingelheim Investigational Site

    Altoona, Pennsylvania

  • 1160.47.01019 Boehringer Ingelheim Investigational Site

    Augusta, Georgia

  • 1160.47.01014 Boehringer Ingelheim Investigational Site

    Baltimore, Maryland

  • 1160.47.01027 Boehringer Ingelheim Investigational Site

    Chapel Hill, North Carolina

  • 1160.47.01044 Boehringer Ingelheim Investigational Site

    Clearwater, Florida

  • 1160.47.01008 Boehringer Ingelheim Investigational Site

    Decatur, Georgia

  • 1160.47.01023 Boehringer Ingelheim Investigational Site

    Detroit, Michigan

  • 1160.47.01030 Boehringer Ingelheim Investigational Site

    Grand Forks, North Dakota

  • 1160.47.01056 Boehringer Ingelheim Investigational Site

    Hartford, Connecticut

  • 1160.47.01031 Boehringer Ingelheim Investigational Site

    Lebanon, New Hampshire

  • 1160.47.01035 Boehringer Ingelheim Investigational Site

    Mobile, Alabama

  • 1160.47.01017 Boehringer Ingelheim Investigational Site

    Richmond, Virginia

  • 1160.47.01018 Boehringer Ingelheim Investigational Site

    Roxbury Crossing, Massachusetts

  • 1160.47.01009 Boehringer Ingelheim Investigational Site

    Saint Louis Park, Minnesota

  • 1160.47.01055 Boehringer Ingelheim Investigational Site

    Summerville, South Carolina

  • 1160.47.01013 Boehringer Ingelheim Investigational Site

    Toledo, Ohio

  • 1160.47.01039 Boehringer Ingelheim Investigational Site

    Winston-Salem, North Carolina

Other trials in United States

Canada15 sites

  • 1160.47.02006 Boehringer Ingelheim Investigational Site

    Edmonton, Alberta

  • 1160.47.02013 Boehringer Ingelheim Investigational Site

    Edmonton, Alberta

  • 1160.47.02001 Boehringer Ingelheim Investigational Site

    Halifax, Nova Scotia

  • 1160.47.02002 Boehringer Ingelheim Investigational Site

    Hamilton, Ontario

  • 1160.47.02005 Boehringer Ingelheim Investigational Site

    Hamilton, Ontario

  • 1160.47.02010 Boehringer Ingelheim Investigational Site

    Hamilton, Ontario

  • 1160.47.02022 Boehringer Ingelheim Investigational Site

    Hamilton, Ontario

  • 1160.47.02008 Boehringer Ingelheim Investigational Site

    Montreal, Quebec

  • 1160.47.02009 Boehringer Ingelheim Investigational Site

    Montreal, Quebec

  • 1160.47.02014 Boehringer Ingelheim Investigational Site

    Montreal, Quebec

  • 1160.47.02017 Boehringer Ingelheim Investigational Site

    Montreal, Quebec

  • 1160.47.02015 Boehringer Ingelheim Investigational Site

    Ottawa, Ontario

  • 1160.47.02004 Boehringer Ingelheim Investigational Site

    Saint Johns, New Brunswick

  • 1160.47.02019 Boehringer Ingelheim Investigational Site

    Toronto, Ontario

  • 1160.47.02021 Boehringer Ingelheim Investigational Site

    Victoria, British Columbia

Other trials in Canada

China15 sites

  • 1160.47.86001 Boehringer Ingelheim Investigational Site

    Beijing

  • 1160.47.86015 Boehringer Ingelheim Investigational Site

    Beijing

  • 1160.47.86014 Boehringer Ingelheim Investigational Site

    Chengdu

  • 1160.47.86012 Boehringer Ingelheim Investigational Site

    Guangzhou

  • 1160.47.86009 Boehringer Ingelheim Investigational Site

    Hangzhou

  • 1160.47.86010 Boehringer Ingelheim Investigational Site

    Hangzhou

  • 1160.47.86013 Boehringer Ingelheim Investigational Site

    Nanjing

  • 1160.47.86002 Boehringer Ingelheim Investigational Site

    Shanghai

  • 1160.47.86003 Boehringer Ingelheim Investigational Site

    Shanghai

  • 1160.47.86004 Boehringer Ingelheim Investigational Site

    Shanghai

  • 1160.47.86005 Boehringer Ingelheim Investigational Site

    Shanghai

  • 1160.47.86006 Boehringer Ingelheim Investigational Site

    Shanghai

  • 1160.47.86007 Boehringer Ingelheim Investigational Site

    Shanghai

  • 1160.47.86016 Boehringer Ingelheim Investigational Site

    Shanghai

  • 1160.47.86011 Boehringer Ingelheim Investigational Site

    Shijiazhuang

Other trials in China

India15 sites

  • 1160.47.91002 Boehringer Ingelheim Investigational Site

    Ahmedabad

  • 1160.47.91011 Boehringer Ingelheim Investigational Site

    Bangalore

  • 1160.47.91015 Boehringer Ingelheim Investigational Site

    Bangalore

  • 1160.47.91012 Boehringer Ingelheim Investigational Site

    Chennai

  • 1160.47.91017 Boehringer Ingelheim Investigational Site

    Chennai

  • 1160.47.91009 Boehringer Ingelheim Investigational Site

    Madurai

  • 1160.47.91007 Boehringer Ingelheim Investigational Site

    Mysore

  • 1160.47.91003 Boehringer Ingelheim Investigational Site

    New Delhi

  • 1160.47.91006 Boehringer Ingelheim Investigational Site

    New Delhi

  • 1160.47.91010 Boehringer Ingelheim Investigational Site

    New Delhi

  • 1160.47.91001 Boehringer Ingelheim Investigational Site

    Pune

  • 1160.47.91005 Boehringer Ingelheim Investigational Site

    Pune

  • 1160.47.91008 Boehringer Ingelheim Investigational Site

    Pune

  • 1160.47.91014 Boehringer Ingelheim Investigational Site

    Trivandrum

  • 1160.47.91004 Boehringer Ingelheim Investigational Site

    Vadodara

Other trials in India

Argentina14 sites

  • 1160.47.54017 Boehringer Ingelheim Investigational Site

    Adrogué

  • 1160.47.54015 Boehringer Ingelheim Investigational Site

    Bahía Blanca

  • 1160.47.54001 Boehringer Ingelheim Investigational Site

    Capital Federal

  • 1160.47.54003 Boehringer Ingelheim Investigational Site

    Capital Federal

  • 1160.47.54005 Boehringer Ingelheim Investigational Site

    Capital Federal

  • 1160.47.54006 Boehringer Ingelheim Investigational Site

    Capital Federal

  • 1160.47.54007 Boehringer Ingelheim Investigational Site

    Capital Federal

  • 1160.47.54010 Boehringer Ingelheim Investigational Site

    Capital Federal

  • 1160.47.54016 Boehringer Ingelheim Investigational Site

    La Plata

  • 1160.47.54014 Boehringer Ingelheim Investigational Site

    Mar del Plata

  • 1160.47.54013 Boehringer Ingelheim Investigational Site

    Quilmes

  • 1160.47.54011 Boehringer Ingelheim Investigational Site

    Rosario

  • 1160.47.54018 Boehringer Ingelheim Investigational Site

    Salta

  • 1160.47.54012 Boehringer Ingelheim Investigational Site

    Santa Fe

Other trials in Argentina

France14 sites

  • 1160.47.3301A Boehringer Ingelheim Investigational Site

    Brest

  • 1160.47.3301B Boehringer Ingelheim Investigational Site

    Brest

  • 1160.47.3301C Boehringer Ingelheim Investigational Site

    Brest

  • 1160.47.3301D Boehringer Ingelheim Investigational Site

    Brest

  • 1160.47.3301E Boehringer Ingelheim Investigational Site

    Brest

  • 1160.47.3301F Boehringer Ingelheim Investigational Site

    Brest

  • 1160.47.3301H Boehringer Ingelheim Investigational Site

    Brest

  • 1160.47.3301I Boehringer Ingelheim Investigational Site

    Brest

  • 1160.47.3302A Boehringer Ingelheim Investigational Site

    Lorient

  • 1160.47.3303A Boehringer Ingelheim Investigational Site

    Saint-Etienne

  • 1160.47.3303B Boehringer Ingelheim Investigational Site

    Saint-Etienne

  • 1160.47.3303C Boehringer Ingelheim Investigational Site

    Saint-Etienne

  • 1160.47.3303D Boehringer Ingelheim Investigational Site

    Saint-Etienne

  • 1160.47.3308A Boehringer Ingelheim Investigational Site

    Vandœuvre-lès-Nancy

Other trials in France

Czechia10 sites

  • 1160.47.42001 Boehringer Ingelheim Investigational Site

    Brno

  • 1160.47.42002 Boehringer Ingelheim Investigational Site

    Hradec Králové

  • 1160.47.42011 Boehringer Ingelheim Investigational Site

    Hranice

  • 1160.47.42012 Boehringer Ingelheim Investigational Site

    Liberec

  • 1160.47.42015 Boehringer Ingelheim Investigational Site

    Nový Jičín

  • 1160.47.42005 Boehringer Ingelheim Investigational Site

    Ostrava-Vitkovice

  • 1160.47.42004 Boehringer Ingelheim Investigational Site

    Prague

  • 1160.47.42014 Boehringer Ingelheim Investigational Site

    Tábor

  • 1160.47.42010 Boehringer Ingelheim Investigational Site

    Ústí nad Labem

  • 1160.47.42007 Boehringer Ingelheim Investigational Site

    Zlín

Other trials in Czechia

Israel10 sites

  • 1160.47.97202 Boehringer Ingelheim Investigational Site

    Afula

  • 1160.47.97207 Boehringer Ingelheim Investigational Site

    Ashkelon

  • 1160.47.97211 Boehringer Ingelheim Investigational Site

    Haifa

  • 1160.47.97203 Boehringer Ingelheim Investigational Site

    Holon

  • 1160.47.97205 Boehringer Ingelheim Investigational Site

    Kfar Saba

  • 1160.47.97206 Boehringer Ingelheim Investigational Site

    Petah Tikva

  • 1160.47.97208 Boehringer Ingelheim Investigational Site

    Rehovot

  • 1160.47.97210 Boehringer Ingelheim Investigational Site

    Tel Aviv

  • 1160.47.97204 Boehringer Ingelheim Investigational Site

    Tel HaShomer

  • 1160.47.97201 Boehringer Ingelheim Investigational Site

    Tsrifin

Other trials in Israel

Hungary9 sites

  • 1160.47.36001 Boehringer Ingelheim Investigational Site

    Budapest

  • 1160.47.36006 Boehringer Ingelheim Investigational Site

    Budapest

  • 1160.47.36007 Boehringer Ingelheim Investigational Site

    Budapest

  • 1160.47.36002 Boehringer Ingelheim Investigational Site

    Debrecen

  • 1160.47.36012 Boehringer Ingelheim Investigational Site

    Gyula

  • 1160.47.36004 Boehringer Ingelheim Investigational Site

    Miskolc

  • 1160.47.36003 Boehringer Ingelheim Investigational Site

    Pécs

  • 1160.47.36010 Boehringer Ingelheim Investigational Site

    Székesfehérvár

  • 1160.47.36011 Boehringer Ingelheim Investigational Site

    Szombathely

Other trials in Hungary

Spain9 sites

  • 1160.47.34006 Boehringer Ingelheim Investigational Site

    Alicante

  • 1160.47.34012 Boehringer Ingelheim Investigational Site

    Badalona (Barcelona)

  • 1160.47.34001 Boehringer Ingelheim Investigational Site

    Barcelona

  • 1160.47.34002 Boehringer Ingelheim Investigational Site

    Barcelona

  • 1160.47.34007 Boehringer Ingelheim Investigational Site

    Cartagena. Murcia

  • 1160.47.34003 Boehringer Ingelheim Investigational Site

    Cuenca

  • 1160.47.34009 Boehringer Ingelheim Investigational Site

    Madrid

  • 1160.47.34004 Boehringer Ingelheim Investigational Site

    Santander

  • 1160.47.34011 Boehringer Ingelheim Investigational Site

    Valencia

Other trials in Spain

Brazil8 sites

  • 1160.47.55010 Boehringer Ingelheim Investigational Site

    Brasília

  • 1160.47.55007 Boehringer Ingelheim Investigational Site

    Campinas - SP

  • 1160.47.55014 Boehringer Ingelheim Investigational Site

    Curitiba

  • 1160.47.55017 Boehringer Ingelheim Investigational Site

    Juvene - Paraná -

  • 1160.47.55012 Boehringer Ingelheim Investigational Site

    pTO aLEGRE

  • 1160.47.55016 Boehringer Ingelheim Investigational Site

    Rio de Janeiro - RJ

  • 1160.47.55018 Boehringer Ingelheim Investigational Site

    São Bernardo do Campo

  • 1160.47.55005 Boehringer Ingelheim Investigational Site

    São José do Rio Preto

Other trials in Brazil

Bulgaria8 sites

  • 1160.47.35910 Boehringer Ingelheim Investigational Site

    Plovdiv

  • 1160.47.35908 Boehringer Ingelheim Investigational Site

    Rousse

  • 1160.47.35901 Boehringer Ingelheim Investigational Site

    Sofia

  • 1160.47.35903 Boehringer Ingelheim Investigational Site

    Sofia

  • 1160.47.35904 Boehringer Ingelheim Investigational Site

    Sofia

  • 1160.47.35906 Boehringer Ingelheim Investigational Site

    Sofia

  • 1160.47.35907 Boehringer Ingelheim Investigational Site

    Sofia

  • 1160.47.35905 Boehringer Ingelheim Investigational Site

    Varna

Other trials in Bulgaria

Germany8 sites

  • 1160.47.49003 Boehringer Ingelheim Investigational Site

    Cologne

  • 1160.47.49017 Boehringer Ingelheim Investigational Site

    Dresden

  • 1160.47.49018 Boehringer Ingelheim Investigational Site

    Dresden

  • 1160.47.49005 Boehringer Ingelheim Investigational Site

    Mannheim

  • 1160.47.49006 Boehringer Ingelheim Investigational Site

    Mannheim

  • 1160.47.49007 Boehringer Ingelheim Investigational Site

    München

  • 1160.47.49008 Boehringer Ingelheim Investigational Site

    München

  • 1160.47.49009 Boehringer Ingelheim Investigational Site

    Püttlingen

Other trials in Germany

Netherlands8 sites

  • 1160.47.31010 Boehringer Ingelheim Investigational Site

    's-Hertogenbosch

  • 1160.47.31001 Boehringer Ingelheim Investigational Site

    Amersfoort

  • 1160.47.31006 Boehringer Ingelheim Investigational Site

    Amsterdam

  • 1160.47.31007 Boehringer Ingelheim Investigational Site

    Amsterdam

  • 1160.47.31014 Boehringer Ingelheim Investigational Site

    Heerlen

  • 1160.47.31005 Boehringer Ingelheim Investigational Site

    Maastricht

  • 1160.47.31004 Boehringer Ingelheim Investigational Site

    Rotterdam

  • 1160.47.31009 Boehringer Ingelheim Investigational Site

    Rotterdam

Other trials in Netherlands

Italy7 sites

  • 1160.47.39003 Boehringer Ingelheim Investigational Site

    Bologna

  • 1160.47.39004 Boehringer Ingelheim Investigational Site

    Cremona

  • 1160.47.39006 Boehringer Ingelheim Investigational Site

    Genova

  • 1160.47.39008 Boehringer Ingelheim Investigational Site

    Milan

  • 1160.47.39007 Boehringer Ingelheim Investigational Site

    Reggio Emilia

  • 1160.47.39009 Boehringer Ingelheim Investigational Site

    Udine

  • 1160.47.39005 Boehringer Ingelheim Investigational Site

    Vittorio Veneto

Other trials in Italy

Sweden7 sites

  • 1160.47.46002 Boehringer Ingelheim Investigational Site

    Gothenburg

  • 1160.47.46006 Boehringer Ingelheim Investigational Site

    Jönköping

  • 1160.47.46001 Boehringer Ingelheim Investigational Site

    Stockholm

  • 1160.47.46007 Boehringer Ingelheim Investigational Site

    Stockholm

  • 1160.47.46008 Boehringer Ingelheim Investigational Site

    Stockholm

  • 1160.47.46005 Boehringer Ingelheim Investigational Site

    Sundsvall

  • 1160.47.46003 Boehringer Ingelheim Investigational Site

    Uppsala

Other trials in Sweden

Turkey (Türkiye)7 sites

  • 1160.47.90003 Boehringer Ingelheim Investigational Site

    Ankara

  • 1160.47.90004 Boehringer Ingelheim Investigational Site

    Ankara

  • 1160.47.90005 Boehringer Ingelheim Investigational Site

    Ankara

  • 1160.47.90001 Boehringer Ingelheim Investigational Site

    Istanbul

  • 1160.47.90002 Boehringer Ingelheim Investigational Site

    Istanbul

  • 1160.47.90007 Boehringer Ingelheim Investigational Site

    Istanbul

  • 1160.47.90006 Boehringer Ingelheim Investigational Site

    Izmir

Other trials in Turkey (Türkiye)

Australia6 sites

  • 1160.47.61004 Boehringer Ingelheim Investigational Site

    Bedford Park, South Australia

  • 1160.47.61003 Boehringer Ingelheim Investigational Site

    Box Hill, Victoria

  • 1160.47.61001 Boehringer Ingelheim Investigational Site

    Clayton, Victoria

  • 1160.47.61005 Boehringer Ingelheim Investigational Site

    Perth, Western Australia

  • 1160.47.61006 Boehringer Ingelheim Investigational Site

    Windsor, Victoria

  • 1160.47.61002 Princess Alexandra Hospital

    Wooloongabba, Queensland

Other trials in Australia

Denmark6 sites

  • 1160.47.45008 Boehringer Ingelheim Investigational Site

    Esbjerg

  • 1160.47.45009 Boehringer Ingelheim Investigational Site

    Holbæk

  • 1160.47.45004 Boehringer Ingelheim Investigational Site

    København NV

  • 1160.47.45007 Boehringer Ingelheim Investigational Site

    København S

  • 1160.47.45002 Boehringer Ingelheim Investigational Site

    Kolding

  • 1160.47.45006 Boehringer Ingelheim Investigational Site

    Slagelse

Other trials in Denmark

Portugal6 sites

  • 1160.47.35104 Boehringer Ingelheim Investigational Site

    Almada

  • 1160.47.35109 Boehringer Ingelheim Investigational Site

    Coimbra

  • 1160.47.35107 Boehringer Ingelheim Investigational Site

    Covilha

  • 1160.47.35101 Boehringer Ingelheim Investigational Site

    Lisbon

  • 1160.47.35102 Boehringer Ingelheim Investigational Site

    Lisbon

  • 1160.47.35105 Boehringer Ingelheim Investigational Site

    Lisbon

Other trials in Portugal

South Africa6 sites

  • 1160.47.27001 Boehringer Ingelheim Investigational Site

    Johannesburg

  • 1160.47.27002 Boehringer Ingelheim Investigational Site

    Johannesburg

  • 1160.47.27006 Boehringer Ingelheim Investigational Site

    Johannesburg

  • 1160.47.27007

    Pretoria

  • 1160.47.27003 Boehringer Ingelheim Investigational Site

    Randburg

  • 1160.47.27005 Boehringer Ingelheim Investigational Site

    Roodepoort

Other trials in South Africa

Finland5 sites

  • 1160.47.35804 Boehringer Ingelheim Investigational Site

    Espoo

  • 1160.47.35801 Boehringer Ingelheim Investigational Site

    Helsinki

  • 1160.47.35802 Boehringer Ingelheim Investigational Site

    Jyväskylä

  • 1160.47.35805 Boehringer Ingelheim Investigational Site

    Kuopio

  • 1160.47.35803 Boehringer Ingelheim Investigational Site

    Tampere

Other trials in Finland

Mexico5 sites

  • 1160.47.52036 Boehringer Ingelheim Investigational Site

    Chihuahua City

  • 1160.47.52039 Boehringer Ingelheim Investigational Site

    Culiacán

  • 1160.47.52030 Boehringer Ingelheim Investigational Site

    Guadalajara, Jal.

  • 1160.47.52027 Boehringer Ingelheim Investigational Site

    Monterrey

  • 1160.47.52034 Boehringer Ingelheim Investigational Site

    San Luis Potosí City

Other trials in Mexico

Poland5 sites

  • 1160.47.48004 Boehringer Ingelheim Investigational Site

    Kielce

  • 1160.47.48005 Boehringer Ingelheim Investigational Site

    Krakow

  • 1160.47.48007 Boehringer Ingelheim Investigational Site

    Krakow

  • 1160.47.48003 Boehringer Ingelheim Investigational Site

    Poznan

  • 1160.47.48006 Boehringer Ingelheim Investigational Site

    Warsaw

Other trials in Poland

Slovakia5 sites

  • 1160.47.42107 Boehringer Ingelheim Investigational Site

    Banská Bystrica

  • 1160.47.42106 Boehringer Ingelheim Investigational Site

    Lučenec

  • 1160.47.42102 Boehringer Ingelheim Investigational Site

    Nitra

  • 1160.47.42103 Boehringer Ingelheim Investigational Site

    Nové Zámky

  • 1160.47.42104 Boehringer Ingelheim Investigational Site

    Žilina

Other trials in Slovakia

United Kingdom5 sites

  • 1160.47.44005 Boehringer Ingelheim Investigational Site

    Headington, Oxford

  • 1160.47.44009 Boehringer Ingelheim Investigational Site

    London

  • 1160.47.44011 Boehringer Ingelheim Investigational Site

    London

  • 1160.47.44006 Boehringer Ingelheim Investigational Site

    Newcastle upon Tyne

  • 1160.47.44012 Boehringer Ingelheim Investigational Site

    Sheffield

Other trials in United Kingdom

Austria4 sites

  • 1160.47.43001 Boehringer Ingelheim Investigational Site

    Graz

  • 1160.47.43003 Boehringer Ingelheim Investigational Site

    Innsbruck

  • 1160.47.43002 Boehringer Ingelheim Investigational Site

    Vienna

  • 1160.47.43004 Boehringer Ingelheim Investigational Site

    Vienna

Other trials in Austria

Belgium4 sites

  • 1160.47.32001 Boehringer Ingelheim Investigational Site

    Brussels

  • 1160.47.32002 Boehringer Ingelheim Investigational Site

    Brussels

  • 1160.47.32005 Boehringer Ingelheim Investigational Site

    Leuven

  • 1160.47.32004 Boehringer Ingelheim Investigational Site

    Liège

Other trials in Belgium

Greece4 sites

  • 1160.47.30001 Boehringer Ingelheim Investigational Site

    Athens

  • 1160.47.30006 Boehringer Ingelheim Investigational Site

    Athens

  • 1160.47.30007 Boehringer Ingelheim Investigational Site

    Athens

  • 1160.47.30009 Boehringer Ingelheim Investigational Site

    Athens

Other trials in Greece

New Zealand4 sites

  • 1160.47.64004 Boehringer Ingelheim Investigational Site

    Christchurch

  • 1160.47.64003 Boehringer Ingelheim Investigational Site

    Grafton

  • 1160.47.64002 Boehringer Ingelheim Investigational Site

    Otahuhu

  • 1160.47.64001 Boehringer Ingelheim Investigational Site

    Takapuna Auckland 9

Other trials in New Zealand

Norway4 sites

  • 1160.47.47001 Boehringer Ingelheim Investigational Site

    Oslo

  • 1160.47.47004 Boehringer Ingelheim Investigational Site

    Oslo

  • 1160.47.47003 Boehringer Ingelheim Investigational Site

    Rud

  • 1160.47.47005 Boehringer Ingelheim Investigational Site

    Trondheim

Other trials in Norway

Ukraine4 sites

  • 1160.47.38002 Boehringer Ingelheim Investigational Site

    Kharkiv

  • 1160.47.38006 Boehringer Ingelheim Investigational Site

    Kiev

  • 1160.47.38005 Boehringer Ingelheim Investigational Site

    Vinnitsa

  • 1160.47.38003 Boehringer Ingelheim Investigational Site

    Zaporizhzhya

Other trials in Ukraine

About this study

Official title: A Phase III, Randomised, Multicenter, Double-blind, Parallel-group, Active Controlled Study to Evaluate the Efficacy and Safety of Oral Dabigatran Etexilate (150 mg Bid) Compared to Warfarin (INR 2.0-3.0) for the Secondary Prevention of Venous Thromboembolism.

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
Being tested
Dabigatran, Warfarin
Medical subject headings
Thromboembolism

What participants receive

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

  • DabigatranDrug

    Dabigatran 150 mg BID (twice daily)

  • WarfarinDrug

    Warfarin dosed individually to maintain INR 2.0-3.0

Study groups in NCT00329238
Study groupRoleWhat they receive
DabigatranExperimentalPatient to receive 1 capsule containing dabigatran 150 mg twice daily plus placebo tablets for warfarin as decided by sham INR measurements
Receives: Drug: Dabigatran
Warfarin (INR of 2.0-3.0)Active comparatorPatient to receive warfarin tablets to target INR 2.0-3.0 plus placebo capsules for dabigatran twice daily
Receives: Drug: Warfarin

What is being measured

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

  1. 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.

    Measured: 36 months

  2. 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.

    Measured: 18 months

Secondary outcomes (13)

  1. Composite of Recurrent VTE or All Cause Death at 36 Months

    Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. 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.

    Measured: 36 months

  2. Composite of Recurrent VTE or All Cause Death at 18 Months

    Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. 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.

    Measured: 18 months

  3. Deep Vein Thrombosis (DVT) at 36 Months

    Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation.

    Measured: 36 months

  4. DVT at 18 Months

    Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation.

    Measured: 18 months

  5. Symptomatic Pulmonary Embolism (PE) at 36 Months

    Symptomatic pulmonary embolism (PE) at 36 Months (fatal or non-fatal). All suspected PEs required confirmation by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) Computed tomography.

    Measured: 36 months

  6. Symptomatic Pulmonary Embolism (PE) at 18 Months

    Symptomatic pulmonary embolism (PE) at 18 Months (fatal or non-fatal). All suspected PEs required confirmation by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) Computed tomography.

    Measured: 18 months

  7. Deaths Related to VTE at 36 Months

    Deaths related to VTE (i.e. fatal PE) at 36 Months. Deaths related to VTE (i.e. fatal PE) at 18 Months. All deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death in a treatment-blinded way.

    Measured: 36 months

  8. Deaths Related to VTE at 18 Months

    Deaths related to VTE (i.e. fatal PE) at 18 Months. All deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death in a treatment-blinded way.

    Measured: 18 months

  9. Deaths of All Causes at 36 Months

    Deaths of all causes at 36 Months. All components of the primary efficacy endpoint and all deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death without knowledge of any individual treatment assignments.

    Measured: 36 months

  10. Deaths of All Causes at 18 Months

    Deaths of all causes at 18 Months. All components of the primary efficacy endpoint and all deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death without knowledge of any individual treatment assignments.

    Measured: 18 months

  11. Number of Participants With Bleeding Events

    MBE (major bleeding event) if it fulfilled at least one of the following criteria

    • 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.

    Minor bleeding event was any bleeding that did not fulfil any of the criteria for MBEs

    CRBE (clinically relevant bleeding event) if it is a minor bleeding events which fulfilled at least one of the following criteria

    • Spontaneous skin haematoma ≥25 cm2
    • Spontaneous nose bleed >5 min duration
    • Macroscopic haematuria, either spontaneous or, if associated with an intervention, lasting >24 h
    • Spontaneous rectal bleeding
    • Gingival bleeding >5 min
    • Bleeding leading to hospitalisation or requiring surgical treatment
    • Bleeding leading to a transfusion of <2 units of whole blood or red cells
    • Any other bleeding event considered clinically relevant by the investigator

    Measured: first intake of study drug until 6 days following last intake of study drug

  12. Laboratory Analysis

    Patients with LFT (liver function tests) increases of possible clinical significance during treatment. Increases of possible clinical significance were defined as: ≥3 x ULN (AST, ALT), ≥2 x ULN (AP), and ≥2 mg/dL (total bilirubin). Only patients with a baseline value which was not of possible clinical significance (or without any baseline value) could have a PCSA (Possible clinically significant abnormality).

    Measured: 18 months + 30 days follow up

  13. Number of Participants With Definite Acute Coronary Syndrome (ACS)

    All suspected ACS occurring during the trial were to be recorded on the CRF and were to be centrally adjudicated by an independent ACS/AC in a treatment-blinded manner.

    Measured: day of first study drug intake until last day of study drug intake; from the day after last intake of study drug until trial termination

Timeline

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

  1. First posted24 May 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionOct 2010

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
2,867 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00329238
Sponsor's protocol ID
1160.47
Other IDs
2005-002536-94, 2005
Acronym
RE-MEDY
Status last verified
Dec 2013
First submitted
23 May 2006
Last updated
19 May 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

  • 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, 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.

    PubMed 23425163

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dabigatran and Warfarin in people with Thromboembolism, run by Boehringer Ingelheim at 275 sites in 33 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 4 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 19 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 275 sites in Russia, United States, Canada, China, India and 28 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 14 Sep 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?

Composite of Recurrent VTE or VTE Death at 36 Months (time frame: 36 months). The study lists 2 primary outcomes in all. 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 NCT00329238, which also lists 3 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 19 May 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in