ThromboembolismPhase 3RE-COVER IINCT00680186

Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp Venous Thromboembolism (VTE)

A Phase 3 study testing Warfarin and Dabigatran etexilate in people with Thromboembolism, run by Boehringer Ingelheim at 220 sites in 31 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 general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin Pro re nata (As needed/PRN) to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic 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?: Warfarin and Dabigatran etexilate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,589 participants
Where: 220 sitesin 31 countries
Study dates: Apr 2008to May 2011
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 symptomatic uni- or bilateral Deep Vein Thrombosis (DVT) of the leg involving proximal veins, and/or Pulmonary Embolism (PE)
Male or female, being 18 years of age or older
Written informed consent for study participation

Who cannot join

Persistent symptoms of VTE
PE requiring urgent intervention
Use of vena cava filter
Contraindications to anticoagulant therapy
Allergy to study medications
Elevated Aspartate-aminotransferase (AST) or Alanine-aminotransferase (ALT) > 3x Upper Limit of Normal (ULN) or known liver disease expected to have an impact on survival
Severe renal impairment
Patients considered unsuitable for inclusion

Trial locations and contacts

220 sites in 31 countries.

Country

City, postcode or hospital

220 sites in 31 countries

China16 sites

1160.46.86001 Boehringer Ingelheim Investigational Site
Beijing
1160.46.86002 Boehringer Ingelheim Investigational Site
Beijing
1160.46.86019 Boehringer Ingelheim Investigational Site
Beijing
1160.46.86014 Boehringer Ingelheim Investigational Site
Guangzhou
1160.46.86015 Boehringer Ingelheim Investigational Site
Guangzhou
1160.46.86016 Boehringer Ingelheim Investigational Site
Hangzhou
1160.46.86003 Boehringer Ingelheim Investigational Site
Shanghai
1160.46.86004 Boehringer Ingelheim Investigational Site
Shanghai
1160.46.86005 Boehringer Ingelheim Investigational Site
Shanghai
1160.46.86011 Boehringer Ingelheim Investigational Site
Shanghai
1160.46.86007 Boehringer Ingelheim Investigational Site
Shenyang
1160.46.86017 Boehringer Ingelheim Investigational Site
Shijiazhuang
1160.46.86018 Boehringer Ingelheim Investigational Site
Shijiazhuang
1160.46.86021 Boehringer Ingelheim Investigational Site
Taiyuan
1160.46.86006 Boehringer Ingelheim Investigational Site
Tianjin
1160.46.86020 Boehringer Ingelheim Investigational Site
Yinchuan

Other trials in China

Canada15 sites

1160.46.02006 Boehringer Ingelheim Investigational Site
Edmonton, Alberta
1160.46.02013 Boehringer Ingelheim Investigational Site
Edmonton, Alberta
1160.46.02001 Boehringer Ingelheim Investigational Site
Halifax, Nova Scotia
1160.46.02002 Boehringer Ingelheim Investigational Site
Hamilton, Ontario
1160.46.02005 Boehringer Ingelheim Investigational Site
Hamilton, Ontario
1160.46.02010 Boehringer Ingelheim Investigational Site
Hamilton, Ontario
1160.46.02008 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1160.46.02009 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1160.46.02014 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1160.46.02017 Boehringer Ingelheim Investigational Site
Montreal, Quebec
1160.46.02015 Boehringer Ingelheim Investigational Site
Ottawa, Ontario
1160.46.02020 Boehringer Ingelheim Investigational Site
Québec, Quebec
1160.46.02004 Boehringer Ingelheim Investigational Site
Saint John, New Brunswick
1160.46.02019 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1160.46.02021 Boehringer Ingelheim Investigational Site
Victoria, British Columbia

Other trials in Canada

France15 sites

1160.46.3301A Boehringer Ingelheim Investigational Site
Brest
1160.46.3301B Boehringer Ingelheim Investigational Site
Brest
1160.46.3315A Boehringer Ingelheim Investigational Site
La Roche-sur-Yon
1160.46.3315B Boehringer Ingelheim Investigational Site
La Roche-sur-Yon
1160.46.3313A Boehringer Ingelheim Investigational Site
Nantes
1160.46.3316A Boehringer Ingelheim Investigational Site
Pessac
1160.46.3316B Boehringer Ingelheim Investigational Site
Pessac
1160.46.3303C Boehringer Ingelheim Investigational Site
Saint-Etienne
1160.46.3303D Boehringer Ingelheim Investigational Site
Saint-Etienne
1160.46.3303E Boehringer Ingelheim Investigational Site
Saint-Etienne
1160.46.3303F Boehringer Ingelheim Investigational Site
Saint-Etienne
1160.46.3303G Boehringer Ingelheim Investigational Site
Saint-Etienne
1160.46.3303H Boehringer Ingelheim Investigational Site
Saint-Etienne
1160.46.3303A Boehringer Ingelheim Investigational Site
Saint-Priest-en-Jarez
1160.46.3303B Boehringer Ingelheim Investigational Site
Saint-Priest-en-Jarez

Other trials in France

India14 sites

1160.46.91006 Boehringer Ingelheim Investigational Site
Bangalore
1160.46.91010 Boehringer Ingelheim Investigational Site
Bangalore
1160.46.91002 Boehringer Ingelheim Investigational Site
Chennai
1160.46.91007 Boehringer Ingelheim Investigational Site
Chennai
1160.46.91012 Boehringer Ingelheim Investigational Site
Kolkata
1160.46.91009 Boehringer Ingelheim Investigational Site
Ludhiana
1160.46.91008 Boehringer Ingelheim Investigational Site
Nagpur
1160.46.91005 Boehringer Ingelheim Investigational Site
New Delhi
1160.46.91014 Boehringer Ingelheim Investigational Site
New Delhi
1160.46.91001 Boehringer Ingelheim Investigational Site
Pune
1160.46.91004 Boehringer Ingelheim Investigational Site
Pune
1160.46.91011 Boehringer Ingelheim Investigational Site
Tamil Nadu
1160.46.91013 Boehringer Ingelheim Investigational Site
Vadodara
1160.46.91003 Boehringer Ingelheim Investigational Site
Vadodra

Other trials in India

Czechia11 sites

1160.46.42001 Boehringer Ingelheim Investigational Site
Brno
1160.46.42002 Boehringer Ingelheim Investigational Site
Hradec Králové
1160.46.42012 Boehringer Ingelheim Investigational Site
Liberec
1160.46.42018 Boehringer Ingelheim Investigational Site
Litoměřice
1160.46.42015 Boehringer Ingelheim Investigational Site
Nový Jičín
1160.46.42005 Boehringer Ingelheim Investigational Site
Ostrava-Vitkovice
1160.46.42017 Boehringer Ingelheim Investigational Site
Prague
1160.46.42014 Boehringer Ingelheim Investigational Site
Tábor
1160.46.42016 Boehringer Ingelheim Investigational Site
Teplice
1160.46.42010 Boehringer Ingelheim Investigational Site
Ústí nad Labem
1160.46.42007 Boehringer Ingelheim Investigational Site
Zlín

Other trials in Czechia

Israel11 sites

1160.46.97202 Boehringer Ingelheim Investigational Site
Afula
1160.46.97207 Boehringer Ingelheim Investigational Site
Ashkelon
1160.46.97212 Boehringer Ingelheim Investigational Site
DN Lower Galillee
1160.46.97211 Boehringer Ingelheim Investigational Site
Haifa
1160.46.97203 Boehringer Ingelheim Investigational Site
Holon
1160.46.97205 Boehringer Ingelheim Investigational Site
KfarSaba
1160.46.97209 Boehringer Ingelheim Investigational Site
Nazareth
1160.46.97206 Boehringer Ingelheim Investigational Site
Petah Tikva
1160.46.97210 Boehringer Ingelheim Investigational Site
Tel Aviv
1160.46.97204 Boehringer Ingelheim Investigational Site
Tel Hashomer, Ramat Gan
1160.46.97201 Boehringer Ingelheim Investigational Site
Tsrifin

Other trials in Israel

United States10 sites

1160.46.01062 Boehringer Ingelheim Investigational Site
Bellevue, Washington
1160.46.01059 Boehringer Ingelheim Investigational Site
Bend, Oregon
1160.46.01044 Boehringer Ingelheim Investigational Site
Clearwater, Florida
1160.46.01061 Boehringer Ingelheim Investigational Site
Columbus, Ohio
1160.46.01063 Boehringer Ingelheim Investigational Site
Corvallis, Oregon
1160.46.01073 Boehringer Ingelheim Investigational Site
Little Rock, Arkansas
1160.46.01068 Boehringer Ingelheim Investigational Site
Normal, Illinois
1160.46.01071 Boehringer Ingelheim Investigational Site
Shreveport, Louisiana
1160.46.01060 Boehringer Ingelheim Investigational Site
Stony Brook, New York
1160.46.01055 Boehringer Ingelheim Investigational Site
Summerville, South Carolina

Other trials in United States

Brazil9 sites

1160.46.55010 Boehringer Ingelheim Investigational Site
Brasília
1160.46.55007 Boehringer Ingelheim Investigational Site
Campinas
1160.46.55014 Boehringer Ingelheim Investigational Site
Curitiba
1160.46.55017 Boehringer Ingelheim Investigational Site
Curitiba
1160.46.55019 Boehringer Ingelheim Investigational Site
Porto Alegre
1160.46.55021 Boehringer Ingelheim Investigational Site
Recife
1160.46.55016 Boehringer Ingelheim Investigational Site
Rio de Janeiro - RJ
1160.46.55018 Boehringer Ingelheim Investigational Site
São Bernardo do Campo
1160.46.55020 Boehringer Ingelheim Investigational Site
São Paulo

Other trials in Brazil

Russia9 sites

1160.46.07021 Boehringer Ingelheim Investigational Site
Chelyabinsk
1160.46.07016 Boehringer Ingelheim Investigational Site
Krasnodar
1160.46.07004 Boehringer Ingelheim Investigational Site
Kursk
1160.46.07009 Boehringer Ingelheim Investigational Site
Rostov-on-Don
1160.46.07024 Boehringer Ingelheim Investigational Site
Rostov-on-Don
1160.46.07014 Boehringer Ingelheim Investigational Site
Ufa
1160.46.07005 Boehringer Ingelheim Investigational Site
Yaroslavl
1160.46.07006 Boehringer Ingelheim Investigational Site
Yaroslavl
1160.46.07007 Boehringer Ingelheim Investigational Site
Yekaterinburg

Other trials in Russia

South Korea9 sites

1160.46.82007 Boehringer Ingelheim Investigational Site
Busan
1160.46.82003 Boehringer Ingelheim Investigational Site
Goyang-si
1160.46.82008 Boehringer Ingelheim Investigational Site
Gyeonggi-do
1160.46.82010 Boehringer Ingelheim Investigational Site
Gyeonggi-do
1160.46.82002 Boehringer Ingelheim Investigational Site
Kyunggi-do
1160.46.82004 Boehringer Ingelheim Investigational Site
Seoul
1160.46.82005 Boehringer Ingelheim Investigational Site
Seoul
1160.46.82006 Boehringer Ingelheim Investigational Site
Seoul
1160.46.82009 Boehringer Ingelheim Investigational Site
Seoul

Other trials in South Korea

Netherlands8 sites

1160.46.31010 Boehringer Ingelheim Investigational Site
's-Hertogenbosch
1160.46.31017 Boehringer Ingelheim Investigational Site
Alkmaar
1160.46.31001 Boehringer Ingelheim Investigational Site
Amersfoort
1160.46.31013 Boehringer Ingelheim Investigational Site
Eindhoven
1160.46.31014 Boehringer Ingelheim Investigational Site
Heerlen
1160.46.31002 Boehringer Ingelheim Investigational Site
Nieuwegein
1160.46.31004 Boehringer Ingelheim Investigational Site
Rotterdam
1160.46.31015 Boehringer Ingelheim Investigational Site
Zwolle

Other trials in Netherlands

South Africa8 sites

1160.46.27001 Boehringer Ingelheim Investigational Site
Bryanston
1160.46.27013 Boehringer Ingelheim Investigational Site
Cape Town
1160.46.27007 Boehringer Ingelheim Investigational Site
Centurion
1160.46.27014 Boehringer Ingelheim Investigational Site
Kempton Park
1160.46.27015 Boehringer Ingelheim Investigational Site
Krugersdorp
1160.46.27002 Boehringer Ingelheim Investigational Site
Morningside
1160.46.27012 Boehringer Ingelheim Investigational Site
Plumstead
1160.46.27006 Boehringer Ingelheim Investigational Site
Sunninghill

Other trials in South Africa

Turkey (Türkiye)8 sites

1160.46.90003 Boehringer Ingelheim Investigational Site
Ankara
1160.46.90004 Boehringer Ingelheim Investigational Site
Ankara
1160.46.90001 Boehringer Ingelheim Investigational Site
Istanbul
1160.46.90002 Boehringer Ingelheim Investigational Site
Istanbul
1160.46.90007 Boehringer Ingelheim Investigational Site
Istanbul
1160.46.90008 Boehringer Ingelheim Investigational Site
Istanbul
1160.46.90009 Boehringer Ingelheim Investigational Site
Istanbul
1160.46.90010 Boehringer Ingelheim Investigational Site
Istanbul

Other trials in Turkey (Türkiye)

Thailand7 sites

1160.46.66007 Boehringer Ingelheim Investigational Site
Bangkok
1160.46.66010 Boehringer Ingelheim Investigational Site
Bangkok
1160.46.66001 Boehringer Ingelheim Investigational Site
Khon Kaen
1160.46.66004 Boehringer Ingelheim Investigational Site
Muang Nakhonratchasima
1160.46.66005 Boehringer Ingelheim Investigational Site
Nakhonratchasima
1160.46.66006 Boehringer Ingelheim Investigational Site
Nokorn Nayok
1160.46.66008 Boehringer Ingelheim Investigational Site
Phayathai

Other trials in Thailand

Italy6 sites

1160.46.39011 Boehringer Ingelheim Investigational Site
Catania
1160.46.39015 Boehringer Ingelheim Investigational Site
Florence
1160.46.39012 Boehringer Ingelheim Investigational Site
Palermo
1160.46.39007 Boehringer Ingelheim Investigational Site
Reggio Emilia
1160.46.39013 Boehringer Ingelheim Investigational Site
Verona
1160.46.39005 Boehringer Ingelheim Investigational Site
Vittorio Veneto (TV)

Other trials in Italy

Spain6 sites

1160.46.34002 Boehringer Ingelheim Investigational Site
Barcelona
1160.46.34007 Boehringer Ingelheim Investigational Site
Cartagena. Murcia
1160.46.34009 Boehringer Ingelheim Investigational Site
Madrid
1160.46.34015 Boehringer Ingelheim Investigational Site
Palma de Mallorca
1160.46.34014 Boehringer Ingelheim Investigational Site
Sabadell - Barcelona
1160.46.34011 Boehringer Ingelheim Investigational Site
Valencia

Other trials in Spain

Australia5 sites

1160.46.61003 Boehringer Ingelheim Investigational Site
Box Hill, Victoria
1160.46.61001 Boehringer Ingelheim Investigational Site
Clayton, Victoria
1160.46.61007 Boehringer Ingelheim Investigational Site
Concord, New South Wales
1160.46.61005 Boehringer Ingelheim Investigational Site
Perth, Western Australia
1160.46.61006 Boehringer Ingelheim Investigational Site
Windsor, Victoria

Other trials in Australia

Poland5 sites

1160.46.48004 Boehringer Ingelheim Investigational Site
Kielce
1160.46.48001 Boehringer Ingelheim Investigational Site
Krakow
1160.46.48005 Boehringer Ingelheim Investigational Site
Krakow
1160.46.48003 Boehringer Ingelheim Investigational Site
Poznan
1160.46.48006 Boehringer Ingelheim Investigational Site
Warsaw

Other trials in Poland

Sweden5 sites

1160.46.46002 Boehringer Ingelheim Investigational Site
Gothenburg
1160.46.46010 Boehringer Ingelheim Investigational Site
Kristianstad
1160.46.46001 Boehringer Ingelheim Investigational Site
Stockholm
1160.46.46008 Boehringer Ingelheim Investigational Site
Stockholm
1160.46.46003 Boehringer Ingelheim Investigational Site
Uppsala

Other trials in Sweden

Taiwan5 sites

1160.46.88607 Boehringer Ingelheim Investigational Site
Changhua
1160.46.88604 Boehringer Ingelheim Investigational Site
Taipei
1160.46.88606 Boehringer Ingelheim Investigational Site
Taipei
1160.46.88608 Boehringer Ingelheim Investigational Site
Taipei
1160.46.88609 Boehringer Ingelheim Investigational Site
Taipei

Other trials in Taiwan

United Kingdom5 sites

1160.46.44005 Boehringer Ingelheim Investigational Site
Headington, Oxford
1160.46.44011 Boehringer Ingelheim Investigational Site
London
1160.46.44006 Boehringer Ingelheim Investigational Site
Newcastle upon Tyne
1160.46.44013 Boehringer Ingelheim Investigational Site
Plymouth
1160.46.44012 Boehringer Ingelheim Investigational Site
Sheffield

Other trials in United Kingdom

Bulgaria4 sites

1160.46.35901 Boehringer Ingelheim Investigational Site
Sofia
1160.46.35903 Boehringer Ingelheim Investigational Site
Sofia
1160.46.35906 Boehringer Ingelheim Investigational Site
Sofia
1160.46.35905 Boehringer Ingelheim Investigational Site
Varna

Other trials in Bulgaria

Denmark4 sites

1160.46.45001 Boehringer Ingelheim Investigational Site
Aarhus C
1160.46.45008 Boehringer Ingelheim Investigational Site
Esbjerg
1160.46.45009 Boehringer Ingelheim Investigational Site
Holbæk
1160.46.45004 Boehringer Ingelheim Investigational Site
København NV

Other trials in Denmark

Malaysia4 sites

1160.46.60001 Boehringer Ingelheim Investigational Site
Kelantan Kota Bahru
1160.46.60004 Boehringer Ingelheim Investigational Site
Kuala Pahang
1160.46.60002 Boehringer Ingelheim Investigational Site
Kuala Selangor
1160.46.60003 Boehringer Ingelheim Investigational Site
Malacca

Other trials in Malaysia

New Zealand4 sites

1160.46.64004 Boehringer Ingelheim Investigational Site
Christchurch
1160.46.64003 Boehringer Ingelheim Investigational Site
Grafton Auckland
1160.46.64002 Boehringer Ingelheim Investigational Site
Otahuhu Auckland
1160.46.64001 Boehringer Ingelheim Investigational Site
Takapuna Auckland

Other trials in New Zealand

Philippines4 sites

1160.46.63005 Boehringer Ingelheim Investigational Site
City of Muntinlupa
1160.46.63001 Boehringer Ingelheim Investigational Site
Manila
1160.46.63003 Boehringer Ingelheim Investigational Site
Quezon City
1160.46.63004 Boehringer Ingelheim Investigational Site
Quezon City

Other trials in Philippines

Slovakia4 sites

1160.46.42107 Boehringer Ingelheim Investigational Site
Banská Bystrica
1160.46.42106 Boehringer Ingelheim Investigational Site
Lučenec
1160.46.42102 Boehringer Ingelheim Investigational Site
Nitra
1160.46.42103 Boehringer Ingelheim Investigational Site
Nové Zámky

Other trials in Slovakia

Hungary3 sites

1160.46.36002 Boehringer Ingelheim Investigational Site
Debrecen
1160.46.36010 Boehringer Ingelheim Investigational Site
Székesfehérvár
1160.46.36011 Boehringer Ingelheim Investigational Site
Szombathely

Other trials in Hungary

Singapore3 sites

1160.46.65001 Boehringer Ingelheim Investigational Site
Singapore
1160.46.65002 Boehringer Ingelheim Investigational Site
Singapore
1160.46.65003 Boehringer Ingelheim Investigational Site
Singapore

Other trials in Singapore

Norway2 sites

1160.46.47001 Boehringer Ingelheim Investigational Site
Oslo
1160.46.47005 Boehringer Ingelheim Investigational Site
Trondheim

Other trials in Norway

Ukraine1 site

1160.46.38005 Boehringer Ingelheim Investigational Site
Vinnitsa

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 Bid) Compared to Warfarin (INR 2.0-3.0) for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism, Following Initial Treatment (5-10 Days) With a Parenteral Anticoagulant Approved for This Indication

The primary objective is to investigate the efficacy of dabigatran compared to warfarin during the 6 month treatment period. The investigation of other selected efficacy aspects and safety are regarded as secondary objective of this trial.

Conditions: Thromboembolism
Being tested: Warfarin, Dabigatran etexilate
Medical subject headings: Thromboembolism

What participants receive

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

WarfarinDrug
PRN (to maintain a target INR of 2.0-3.0)
Dabigatran etexilateDrug
150mg bid

Study groups in NCT00680186
Study group	Role	What they receive
Dabigatran etexilate (150mg bid)	Experimental	Patients will receive 1 capsule containing 150 mg dabigatran etexilate/matching placebo twice daily Receives: Drug: Dabigatran etexilate
Warfarin (INR 2.0-3.0)	Active comparator	Patients will receive tablets PRN warfarin/matching placebo to maintain a target INR of 2.0-3.0 Receives: Drug: Warfarin

What is being measured

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

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 (9)

Number of Participants With Recurrent Symptomatic VTE and All Deaths
VTE or any death which occured from randomisation to end of ptp. 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.
Number of Participants With Recurrent Symptomatic DVT
Symptomatic DVT which occured from randomisation to end of ptp. 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.
Number of Participants With Recurrent Symptomatic Non-fatal PE
Symptomatic non-fatal PE which occured from randomisation to end of ptp. 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.
Number of Participants Who Died Due to VTE
VTE - related deaths which occured from randomisation to end of ptp. 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. Hazard ratios and 95% CI were not calculated because of insufficient number of events.
Measured: From randomisation to 6 months (up to day 180) and to end of ptp (planned to be up to day 224)
Number of Participants Who Died (Any Cause)
Any deaths which occured from randomisation to end of ptp. 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.
Number of Participants With Recurrent Symptomatic Fatal and Non-fatal PE
Symptomatic fatal and non-fatal PE which occured from randomisation to end of ptp. 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.
Number of Participants With MBE, MBE and/or CRBE, and Any Bleeding Events
Major bleeding events (MBE) are 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) are defined as
- spontaneous skin hematoma >=25 cm²
- wound hematoma >=100 cm²
- spontaneous nose bleed >5 min
- macroscopic hematuria spontaneous or >24 hours if associated with an intervention
- spontaneous rectal bleeding
- 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
Number of Participants With Acute Coronary Syndrome (ACS)
Any ACS occurring during the conduct of the study (centrally adjudicated as definite). Patients having a centrally adjudicated definite ACS during intake of study drug and after stopping study drug, according to treatment group. ACS assessments pre-specified in the protocol without adjudication. Prior to database lock, the steering committee asked to have ACS events adjudicated by an independent committee. After database lock, the committee was provided with source documentation that was blinded to the patient's treatment assignment. ACS results presented are based on adjudication findings.
Measured: From first intake of study drug to last contact date
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

Timeline

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

Apr 2008May 2011

First posted20 May 2008 (estimated)
Study startApr 2008
Primary completionMay 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for ThromboembolismStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 2,589 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00680186
Sponsor's protocol ID: 1160.46
Other IDs: 2007-002631-86
Acronym: RE-COVER II
Status last verified: Dec 2013
First submitted: 16 May 2008
Last updated: 19 May 2014
Results posted: Yes, on ClinicalTrials.gov

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Thromboembolism trials

Study at a glance

From the registry record, last updated by the sponsor on 19 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Randomised, Double Blind, Parallel-group Study of the Efficacy and Safety of Oral Dabigatran Etexilate (150 mg Bid) Compared to Warfarin (INR 2.0-3.0) for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism, Following Initial Treatment (5-10 Days) With a Parenteral Anticoagulant Approved for This Indication
ClinicalTrials.gov ID: NCT00680186
Acronym / sponsor ID: RE-COVER II / 1160.46
Conditions: Thromboembolism
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,589 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Apr 2008
Primary completion: May 2011 (actual)
First posted: 20 May 2008 (estimated)
Results: Posted 14 Jun 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 2

Arm	Type	Receives
Dabigatran etexilate (150mg bid)	Experimental	Drug: Dabigatran etexilatePatients will receive 1 capsule containing 150 mg dabigatran etexilate/matching placebo twice daily
Warfarin (INR 2.0-3.0)	Active comparator	Drug: WarfarinPatients will receive tablets PRN warfarin/matching placebo to maintain a target INR of 2.0-3.0

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Acute symptomatic uni- or bilateral Deep Vein Thrombosis (DVT) of the leg involving proximal veins, and/or Pulmonary Embolism (PE)
Male or female, being 18 years of age or older
Written informed consent for study participation

Key exclusion criteria (8 listed)

Persistent symptoms of VTE
PE requiring urgent intervention
Use of vena cava filter
Contraindications to anticoagulant therapy
Allergy to study medications

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
WarfarinPRN (to maintain a target INR of 2.0-3.0)	Drug	Warfarin (INR 2.0-3.0)
Dabigatran etexilate150mg bid	Drug	Dabigatran etexilate (150mg bid)

Primary outcome

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)
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.

9 secondary outcomes

Number of Participants With Recurrent Symptomatic VTE and All Deaths
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From randomisation to 6 months (up to day 180) and to end of ptp (planned to be up to day 224)
Number of Participants Who Died (Any Cause)
Time frame: 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 Fatal and Non-fatal PE
Time frame: 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 MBE, MBE and/or CRBE, and Any Bleeding Events
Time frame: From first intake of study drug to last intake of study drug + 6 days washout
Number of Participants With Acute Coronary Syndrome (ACS)
Time frame: From first intake of study drug to last contact date
Laboratory Analyses
Time frame: From first intake of study drug to last intake of study drug + 6 days washout

Results and safety

Results posted to the registry on 14 Jun 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dabigatran 150 mg	1,280	1,155
Warfarin	1,288	1,172

Primary outcome: 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). Number. Unit: participants

Measure	Dabigatran 150 mg n = 1279	Warfarin n = 1289
Participants with event (up to day 180)	30	28
Participants with event (up to end of ptp)	34	30

Dabigatran 150 mg vs Warfarin: Hazard Ratio (HR): 1.13 (95% CI 0.69 to 1.85), p = 0.0002, Regression, Cox
Dabigatran 150 mg vs Warfarin: Risk Difference (Percentage): 0.2 (95% CI -1.0 to 1.3), p <0.0001, Kaplan Meier weighted estimates
Dabigatran 150 mg vs Warfarin: Hazard Ratio (HR): 1.08 (95% CI 0.64 to 1.8), Regression, Cox

Population analysed: Full analysis set (FAS): consisted of all randomised patients who were documented to have taken at least one dose of study drug. Patients were assigned to the treatment groups as randomised, i.e. regardless of the actual medication taken.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first intake of study drug to last intake of study drug + 6 days washout. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dabigatran 150 mg	156 of 1,280 (12.2%)	124 of 1,280 (9.7%)	Not reported
Warfarin	153 of 1,288 (11.9%)	126 of 1,288 (9.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27807306Goldhaber 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.
Derived from this study: PubMed 24344086Schulman 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.
Derived from this study: PubMed 24081972Majeed 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.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

220 sites in 31 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Warfarin and Dabigatran etexilate in people with Thromboembolism, run by Boehringer Ingelheim at 220 sites in 31 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 8 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 220 sites in China, Canada, France, India, Czechia and 26 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 Jun 2012). 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 NCT00680186, 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.