Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp Venous Thromboembolism (VTE)
NCT ID: NCT00680186
Last Updated: 2014-05-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2589 participants
INTERVENTIONAL
2008-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Dabigatran etexilate (150mg bid)
Patients will receive 1 capsule containing 150 mg dabigatran etexilate/matching placebo twice daily
Dabigatran etexilate
150mg bid
Warfarin (INR 2.0-3.0)
Patients will receive tablets PRN warfarin/matching placebo to maintain a target INR of 2.0-3.0
Warfarin
PRN (to maintain a target INR of 2.0-3.0)
Interventions
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Warfarin
PRN (to maintain a target INR of 2.0-3.0)
Dabigatran etexilate
150mg bid
Eligibility Criteria
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Inclusion Criteria
* Male or female, being 18 years of age or older
* Written informed consent for study participation
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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1160.46.01073 Boehringer Ingelheim Investigational Site
Little Rock, Arkansas, United States
1160.46.01044 Boehringer Ingelheim Investigational Site
Clearwater, Florida, United States
1160.46.01068 Boehringer Ingelheim Investigational Site
Normal, Illinois, United States
1160.46.01071 Boehringer Ingelheim Investigational Site
Shreveport, Louisiana, United States
1160.46.01060 Boehringer Ingelheim Investigational Site
Stony Brook, New York, United States
1160.46.01061 Boehringer Ingelheim Investigational Site
Columbus, Ohio, United States
1160.46.01059 Boehringer Ingelheim Investigational Site
Bend, Oregon, United States
1160.46.01063 Boehringer Ingelheim Investigational Site
Corvallis, Oregon, United States
1160.46.01055 Boehringer Ingelheim Investigational Site
Summerville, South Carolina, United States
1160.46.01062 Boehringer Ingelheim Investigational Site
Bellevue, Washington, United States
1160.46.61007 Boehringer Ingelheim Investigational Site
Concord, New South Wales, Australia
1160.46.61003 Boehringer Ingelheim Investigational Site
Box Hill, Victoria, Australia
1160.46.61001 Boehringer Ingelheim Investigational Site
Clayton, Victoria, Australia
1160.46.61006 Boehringer Ingelheim Investigational Site
Windsor, Victoria, Australia
1160.46.61005 Boehringer Ingelheim Investigational Site
Perth, Western Australia, Australia
1160.46.55010 Boehringer Ingelheim Investigational Site
Brasília, , Brazil
1160.46.55007 Boehringer Ingelheim Investigational Site
Campinas, , Brazil
1160.46.55014 Boehringer Ingelheim Investigational Site
Curitiba, , Brazil
1160.46.55017 Boehringer Ingelheim Investigational Site
Curitiba, , Brazil
1160.46.55019 Boehringer Ingelheim Investigational Site
Porto Alegre, , Brazil
1160.46.55021 Boehringer Ingelheim Investigational Site
Recife, , Brazil
1160.46.55016 Boehringer Ingelheim Investigational Site
Rio de Janeiro - RJ, , Brazil
1160.46.55018 Boehringer Ingelheim Investigational Site
São Bernardo do Campo, , Brazil
1160.46.55020 Boehringer Ingelheim Investigational Site
São Paulo, , Brazil
1160.46.35901 Boehringer Ingelheim Investigational Site
Sofia, , Bulgaria
1160.46.35903 Boehringer Ingelheim Investigational Site
Sofia, , Bulgaria
1160.46.35906 Boehringer Ingelheim Investigational Site
Sofia, , Bulgaria
1160.46.35905 Boehringer Ingelheim Investigational Site
Varna, , Bulgaria
1160.46.02006 Boehringer Ingelheim Investigational Site
Edmonton, Alberta, Canada
1160.46.02013 Boehringer Ingelheim Investigational Site
Edmonton, Alberta, Canada
1160.46.02021 Boehringer Ingelheim Investigational Site
Victoria, British Columbia, Canada
1160.46.02004 Boehringer Ingelheim Investigational Site
Saint John, New Brunswick, Canada
1160.46.02001 Boehringer Ingelheim Investigational Site
Halifax, Nova Scotia, Canada
1160.46.02002 Boehringer Ingelheim Investigational Site
Hamilton, Ontario, Canada
1160.46.02005 Boehringer Ingelheim Investigational Site
Hamilton, Ontario, Canada
1160.46.02010 Boehringer Ingelheim Investigational Site
Hamilton, Ontario, Canada
1160.46.02015 Boehringer Ingelheim Investigational Site
Ottawa, Ontario, Canada
1160.46.02019 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
1160.46.02008 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
1160.46.02009 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
1160.46.02014 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
1160.46.02017 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
1160.46.02020 Boehringer Ingelheim Investigational Site
Québec, Quebec, Canada
1160.46.86001 Boehringer Ingelheim Investigational Site
Beijing, , China
1160.46.86002 Boehringer Ingelheim Investigational Site
Beijing, , China
1160.46.86019 Boehringer Ingelheim Investigational Site
Beijing, , China
1160.46.86014 Boehringer Ingelheim Investigational Site
Guangzhou, , China
1160.46.86015 Boehringer Ingelheim Investigational Site
Guangzhou, , China
1160.46.86016 Boehringer Ingelheim Investigational Site
Hangzhou, , China
1160.46.86003 Boehringer Ingelheim Investigational Site
Shanghai, , China
1160.46.86004 Boehringer Ingelheim Investigational Site
Shanghai, , China
1160.46.86005 Boehringer Ingelheim Investigational Site
Shanghai, , China
1160.46.86011 Boehringer Ingelheim Investigational Site
Shanghai, , China
1160.46.86007 Boehringer Ingelheim Investigational Site
Shenyang, , China
1160.46.86017 Boehringer Ingelheim Investigational Site
Shijiazhuang, , China
1160.46.86018 Boehringer Ingelheim Investigational Site
Shijiazhuang, , China
1160.46.86021 Boehringer Ingelheim Investigational Site
Taiyuan, , China
1160.46.86006 Boehringer Ingelheim Investigational Site
Tianjin, , China
1160.46.86020 Boehringer Ingelheim Investigational Site
Yinchuan, , China
1160.46.42001 Boehringer Ingelheim Investigational Site
Brno, , Czechia
1160.46.42002 Boehringer Ingelheim Investigational Site
Hradec Králové, , Czechia
1160.46.42012 Boehringer Ingelheim Investigational Site
Liberec, , Czechia
1160.46.42018 Boehringer Ingelheim Investigational Site
Litoměřice, , Czechia
1160.46.42015 Boehringer Ingelheim Investigational Site
Nový Jičín, , Czechia
1160.46.42005 Boehringer Ingelheim Investigational Site
Ostrava-Vitkovice, , Czechia
1160.46.42017 Boehringer Ingelheim Investigational Site
Prague, , Czechia
1160.46.42014 Boehringer Ingelheim Investigational Site
Tábor, , Czechia
1160.46.42016 Boehringer Ingelheim Investigational Site
Teplice, , Czechia
1160.46.42010 Boehringer Ingelheim Investigational Site
Ústí nad Labem, , Czechia
1160.46.42007 Boehringer Ingelheim Investigational Site
Zlín, , Czechia
1160.46.45001 Boehringer Ingelheim Investigational Site
Aarhus C, , Denmark
1160.46.45008 Boehringer Ingelheim Investigational Site
Esbjerg, , Denmark
1160.46.45009 Boehringer Ingelheim Investigational Site
Holbæk, , Denmark
1160.46.45004 Boehringer Ingelheim Investigational Site
København NV, , Denmark
1160.46.3301A Boehringer Ingelheim Investigational Site
Brest, , France
1160.46.3301B Boehringer Ingelheim Investigational Site
Brest, , France
1160.46.3315A Boehringer Ingelheim Investigational Site
La Roche-sur-Yon, , France
1160.46.3315B Boehringer Ingelheim Investigational Site
La Roche-sur-Yon, , France
1160.46.3313A Boehringer Ingelheim Investigational Site
Nantes, , France
1160.46.3316A Boehringer Ingelheim Investigational Site
Pessac, , France
1160.46.3316B Boehringer Ingelheim Investigational Site
Pessac, , France
1160.46.3303C Boehringer Ingelheim Investigational Site
Saint-Etienne, , France
1160.46.3303D Boehringer Ingelheim Investigational Site
Saint-Etienne, , France
1160.46.3303E Boehringer Ingelheim Investigational Site
Saint-Etienne, , France
1160.46.3303F Boehringer Ingelheim Investigational Site
Saint-Etienne, , France
1160.46.3303G Boehringer Ingelheim Investigational Site
Saint-Etienne, , France
1160.46.3303H Boehringer Ingelheim Investigational Site
Saint-Etienne, , France
1160.46.3303A Boehringer Ingelheim Investigational Site
Saint-Priest-en-Jarez, , France
1160.46.3303B Boehringer Ingelheim Investigational Site
Saint-Priest-en-Jarez, , France
1160.46.36002 Boehringer Ingelheim Investigational Site
Debrecen, , Hungary
1160.46.36010 Boehringer Ingelheim Investigational Site
Székesfehérvár, , Hungary
1160.46.36011 Boehringer Ingelheim Investigational Site
Szombathely, , Hungary
1160.46.91006 Boehringer Ingelheim Investigational Site
Bangalore, , India
1160.46.91010 Boehringer Ingelheim Investigational Site
Bangalore, , India
1160.46.91002 Boehringer Ingelheim Investigational Site
Chennai, , India
1160.46.91007 Boehringer Ingelheim Investigational Site
Chennai, , India
1160.46.91012 Boehringer Ingelheim Investigational Site
Kolkata, , India
1160.46.91009 Boehringer Ingelheim Investigational Site
Ludhiana, , India
1160.46.91008 Boehringer Ingelheim Investigational Site
Nagpur, , India
1160.46.91005 Boehringer Ingelheim Investigational Site
New Delhi, , India
1160.46.91014 Boehringer Ingelheim Investigational Site
New Delhi, , India
1160.46.91001 Boehringer Ingelheim Investigational Site
Pune, , India
1160.46.91004 Boehringer Ingelheim Investigational Site
Pune, , India
1160.46.91011 Boehringer Ingelheim Investigational Site
Tamil Nadu, , India
1160.46.91013 Boehringer Ingelheim Investigational Site
Vadodara, , India
1160.46.91003 Boehringer Ingelheim Investigational Site
Vadodra, , India
1160.46.97202 Boehringer Ingelheim Investigational Site
Afula, , Israel
1160.46.97207 Boehringer Ingelheim Investigational Site
Ashkelon, , Israel
1160.46.97212 Boehringer Ingelheim Investigational Site
DN Lower Galillee, , Israel
1160.46.97211 Boehringer Ingelheim Investigational Site
Haifa, , Israel
1160.46.97203 Boehringer Ingelheim Investigational Site
Holon, , Israel
1160.46.97205 Boehringer Ingelheim Investigational Site
KfarSaba, , Israel
1160.46.97209 Boehringer Ingelheim Investigational Site
Nazareth, , Israel
1160.46.97206 Boehringer Ingelheim Investigational Site
Petah Tikva, , Israel
1160.46.97210 Boehringer Ingelheim Investigational Site
Tel Aviv, , Israel
1160.46.97204 Boehringer Ingelheim Investigational Site
Tel Hashomer, Ramat Gan, , Israel
1160.46.97201 Boehringer Ingelheim Investigational Site
Ẕerifin, , Israel
1160.46.39011 Boehringer Ingelheim Investigational Site
Catania, , Italy
1160.46.39015 Boehringer Ingelheim Investigational Site
Florence, , Italy
1160.46.39012 Boehringer Ingelheim Investigational Site
Palermo, , Italy
1160.46.39007 Boehringer Ingelheim Investigational Site
Reggio Emilia, , Italy
1160.46.39013 Boehringer Ingelheim Investigational Site
Verona, , Italy
1160.46.39005 Boehringer Ingelheim Investigational Site
Vittorio Veneto (TV), , Italy
1160.46.60001 Boehringer Ingelheim Investigational Site
Kelantan Kota Bahru, , Malaysia
1160.46.60004 Boehringer Ingelheim Investigational Site
Kuala Pahang, , Malaysia
1160.46.60002 Boehringer Ingelheim Investigational Site
Kuala Selangor, , Malaysia
1160.46.60003 Boehringer Ingelheim Investigational Site
Malacca, , Malaysia
1160.46.31010 Boehringer Ingelheim Investigational Site
's-Hertogenbosch, , Netherlands
1160.46.31017 Boehringer Ingelheim Investigational Site
Alkmaar, , Netherlands
1160.46.31001 Boehringer Ingelheim Investigational Site
Amersfoort, , Netherlands
1160.46.31013 Boehringer Ingelheim Investigational Site
Eindhoven, , Netherlands
1160.46.31014 Boehringer Ingelheim Investigational Site
Heerlen, , Netherlands
1160.46.31002 Boehringer Ingelheim Investigational Site
Nieuwegein, , Netherlands
1160.46.31004 Boehringer Ingelheim Investigational Site
Rotterdam, , Netherlands
1160.46.31015 Boehringer Ingelheim Investigational Site
Zwolle, , Netherlands
1160.46.64004 Boehringer Ingelheim Investigational Site
Christchurch, , New Zealand
1160.46.64003 Boehringer Ingelheim Investigational Site
Grafton Auckland, , New Zealand
1160.46.64002 Boehringer Ingelheim Investigational Site
Otahuhu Auckland, , New Zealand
1160.46.64001 Boehringer Ingelheim Investigational Site
Takapuna Auckland, , New Zealand
1160.46.47001 Boehringer Ingelheim Investigational Site
Oslo, , Norway
1160.46.47005 Boehringer Ingelheim Investigational Site
Trondheim, , Norway
1160.46.63005 Boehringer Ingelheim Investigational Site
City of Muntinlupa, , Philippines
1160.46.63001 Boehringer Ingelheim Investigational Site
Manila, , Philippines
1160.46.63003 Boehringer Ingelheim Investigational Site
Quezon City, , Philippines
1160.46.63004 Boehringer Ingelheim Investigational Site
Quezon City, , Philippines
1160.46.48004 Boehringer Ingelheim Investigational Site
Kielce, , Poland
1160.46.48001 Boehringer Ingelheim Investigational Site
Krakow, , Poland
1160.46.48005 Boehringer Ingelheim Investigational Site
Krakow, , Poland
1160.46.48003 Boehringer Ingelheim Investigational Site
Poznan, , Poland
1160.46.48006 Boehringer Ingelheim Investigational Site
Warsaw, , Poland
1160.46.07021 Boehringer Ingelheim Investigational Site
Chelyabinsk, , Russia
1160.46.07016 Boehringer Ingelheim Investigational Site
Krasnodar, , Russia
1160.46.07004 Boehringer Ingelheim Investigational Site
Kursk, , Russia
1160.46.07009 Boehringer Ingelheim Investigational Site
Rostov-on-Don, , Russia
1160.46.07024 Boehringer Ingelheim Investigational Site
Rostov-on-Don, , Russia
1160.46.07014 Boehringer Ingelheim Investigational Site
Ufa, , Russia
1160.46.07005 Boehringer Ingelheim Investigational Site
Yaroslavl, , Russia
1160.46.07006 Boehringer Ingelheim Investigational Site
Yaroslavl, , Russia
1160.46.07007 Boehringer Ingelheim Investigational Site
Yekaterinburg, , Russia
1160.46.65001 Boehringer Ingelheim Investigational Site
Singapore, , Singapore
1160.46.65002 Boehringer Ingelheim Investigational Site
Singapore, , Singapore
1160.46.65003 Boehringer Ingelheim Investigational Site
Singapore, , Singapore
1160.46.42107 Boehringer Ingelheim Investigational Site
Banská Bystrica, , Slovakia
1160.46.42106 Boehringer Ingelheim Investigational Site
Lučenec, , Slovakia
1160.46.42102 Boehringer Ingelheim Investigational Site
Nitra, , Slovakia
1160.46.42103 Boehringer Ingelheim Investigational Site
Nové Zámky, , Slovakia
1160.46.27001 Boehringer Ingelheim Investigational Site
Bryanston, , South Africa
1160.46.27013 Boehringer Ingelheim Investigational Site
Cape Town, , South Africa
1160.46.27007 Boehringer Ingelheim Investigational Site
Centurion, , South Africa
1160.46.27014 Boehringer Ingelheim Investigational Site
Kempton Park, , South Africa
1160.46.27015 Boehringer Ingelheim Investigational Site
Krugersdorp, , South Africa
1160.46.27002 Boehringer Ingelheim Investigational Site
Morningside, , South Africa
1160.46.27012 Boehringer Ingelheim Investigational Site
Plumstead, , South Africa
1160.46.27006 Boehringer Ingelheim Investigational Site
Sunninghill, , South Africa
1160.46.82007 Boehringer Ingelheim Investigational Site
Busan, , South Korea
1160.46.82003 Boehringer Ingelheim Investigational Site
Goyang-si, , South Korea
1160.46.82008 Boehringer Ingelheim Investigational Site
Gyeonggi-do, , South Korea
1160.46.82010 Boehringer Ingelheim Investigational Site
Gyeonggi-do, , South Korea
1160.46.82002 Boehringer Ingelheim Investigational Site
Kyunggi-do, , South Korea
1160.46.82004 Boehringer Ingelheim Investigational Site
Seoul, , South Korea
1160.46.82005 Boehringer Ingelheim Investigational Site
Seoul, , South Korea
1160.46.82006 Boehringer Ingelheim Investigational Site
Seoul, , South Korea
1160.46.82009 Boehringer Ingelheim Investigational Site
Seoul, , South Korea
1160.46.34002 Boehringer Ingelheim Investigational Site
Barcelona, , Spain
1160.46.34007 Boehringer Ingelheim Investigational Site
Cartagena. Murcia, , Spain
1160.46.34009 Boehringer Ingelheim Investigational Site
Madrid, , Spain
1160.46.34015 Boehringer Ingelheim Investigational Site
Palma de Mallorca, , Spain
1160.46.34014 Boehringer Ingelheim Investigational Site
Sabadell - Barcelona, , Spain
1160.46.34011 Boehringer Ingelheim Investigational Site
Valencia, , Spain
1160.46.46002 Boehringer Ingelheim Investigational Site
Gothenburg, , Sweden
1160.46.46010 Boehringer Ingelheim Investigational Site
Kristianstad, , Sweden
1160.46.46001 Boehringer Ingelheim Investigational Site
Stockholm, , Sweden
1160.46.46008 Boehringer Ingelheim Investigational Site
Stockholm, , Sweden
1160.46.46003 Boehringer Ingelheim Investigational Site
Uppsala, , Sweden
1160.46.88607 Boehringer Ingelheim Investigational Site
Changhua, , Taiwan
1160.46.88604 Boehringer Ingelheim Investigational Site
Taipei, , Taiwan
1160.46.88606 Boehringer Ingelheim Investigational Site
Taipei, , Taiwan
1160.46.88608 Boehringer Ingelheim Investigational Site
Taipei, , Taiwan
1160.46.88609 Boehringer Ingelheim Investigational Site
Taipei, , Taiwan
1160.46.66007 Boehringer Ingelheim Investigational Site
Bangkok, , Thailand
1160.46.66010 Boehringer Ingelheim Investigational Site
Bangkok, , Thailand
1160.46.66001 Boehringer Ingelheim Investigational Site
Khon Kaen, , Thailand
1160.46.66004 Boehringer Ingelheim Investigational Site
Muang Nakhonratchasima, , Thailand
1160.46.66005 Boehringer Ingelheim Investigational Site
Nakhonratchasima, , Thailand
1160.46.66006 Boehringer Ingelheim Investigational Site
Nokorn Nayok, , Thailand
1160.46.66008 Boehringer Ingelheim Investigational Site
Phayathai, , Thailand
1160.46.90003 Boehringer Ingelheim Investigational Site
Ankara, , Turkey (Türkiye)
1160.46.90004 Boehringer Ingelheim Investigational Site
Ankara, , Turkey (Türkiye)
1160.46.90001 Boehringer Ingelheim Investigational Site
Istanbul, , Turkey (Türkiye)
1160.46.90002 Boehringer Ingelheim Investigational Site
Istanbul, , Turkey (Türkiye)
1160.46.90007 Boehringer Ingelheim Investigational Site
Istanbul, , Turkey (Türkiye)
1160.46.90008 Boehringer Ingelheim Investigational Site
Istanbul, , Turkey (Türkiye)
1160.46.90009 Boehringer Ingelheim Investigational Site
Istanbul, , Turkey (Türkiye)
1160.46.90010 Boehringer Ingelheim Investigational Site
Istanbul, , Turkey (Türkiye)
1160.46.38005 Boehringer Ingelheim Investigational Site
Vinnitsa, , Ukraine
1160.46.44005 Boehringer Ingelheim Investigational Site
Headington, Oxford, , United Kingdom
1160.46.44011 Boehringer Ingelheim Investigational Site
London, , United Kingdom
1160.46.44006 Boehringer Ingelheim Investigational Site
Newcastle upon Tyne, , United Kingdom
1160.46.44013 Boehringer Ingelheim Investigational Site
Plymouth, , United Kingdom
1160.46.44012 Boehringer Ingelheim Investigational Site
Sheffield, , United Kingdom
Countries
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References
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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.
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.
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.
Other Identifiers
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2007-002631-86
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1160.46
Identifier Type: -
Identifier Source: org_study_id
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