Clinical trial NCT00680186: Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp Venous Thromboembolism (VTE)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Thromboembolism
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-05-20
Enrollment: 2589
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.


Eligibility criteria: Inclusion criteria:

* 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

Exclusion criteria:

* 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

Primary outcomes:
measure: Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE
timeFrame: 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:
measure: Number of Participants With Recurrent Symptomatic VTE and All Deaths
timeFrame: 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.
measure: Number of Participants With Recurrent Symptomatic DVT
timeFrame: 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.
measure: Number of Participants With Recurrent Symptomatic Non-fatal PE
timeFrame: 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.
measure: Number of Participants Who Died Due to VTE
timeFrame: From randomisation to 6 months (up to day 180) and to end of ptp (planned to be up to day 224)
measure: Number of Participants Who Died (Any Cause)
timeFrame: 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.
measure: Number of Participants With Recurrent Symptomatic Fatal and Non-fatal PE
timeFrame: 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.
measure: Number of Participants With MBE, MBE and/or CRBE, and Any Bleeding Events
timeFrame: From first intake of study drug to last intake of study drug + 6 days washout
measure: Number of Participants With Acute Coronary Syndrome (ACS)
timeFrame: From first intake of study drug to last contact date
measure: Laboratory Analyses
timeFrame: From first intake of study drug to last intake of study drug + 6 days washout
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: 1160.46.01073 Boehringer Ingelheim Investigational Site
state: Arkansas
city: Clearwater
country: United States
facility: 1160.46.01044 Boehringer Ingelheim Investigational Site
state: Florida
city: Normal
country: United States
facility: 1160.46.01068 Boehringer Ingelheim Investigational Site
state: Illinois
city: Shreveport
country: United States
facility: 1160.46.01071 Boehringer Ingelheim Investigational Site
state: Louisiana
city: Stony Brook
country: United States
facility: 1160.46.01060 Boehringer Ingelheim Investigational Site
state: New York
city: Columbus
country: United States
facility: 1160.46.01061 Boehringer Ingelheim Investigational Site
state: Ohio
city: Bend
country: United States
facility: 1160.46.01059 Boehringer Ingelheim Investigational Site
state: Oregon
city: Corvallis
country: United States
facility: 1160.46.01063 Boehringer Ingelheim Investigational Site
state: Oregon
city: Summerville
country: United States
facility: 1160.46.01055 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Bellevue
country: United States
facility: 1160.46.01062 Boehringer Ingelheim Investigational Site
state: Washington
city: Concord
country: Australia
facility: 1160.46.61007 Boehringer Ingelheim Investigational Site
state: New South Wales
city: Box Hill
country: Australia
facility: 1160.46.61003 Boehringer Ingelheim Investigational Site
state: Victoria
city: Clayton
country: Australia
facility: 1160.46.61001 Boehringer Ingelheim Investigational Site
state: Victoria
city: Windsor
country: Australia
facility: 1160.46.61006 Boehringer Ingelheim Investigational Site
state: Victoria
city: Perth
country: Australia
facility: 1160.46.61005 Boehringer Ingelheim Investigational Site
state: Western Australia
city: Brasília
country: Brazil
facility: 1160.46.55010 Boehringer Ingelheim Investigational Site
city: Campinas
country: Brazil
facility: 1160.46.55007 Boehringer Ingelheim Investigational Site
city: Curitiba
country: Brazil
facility: 1160.46.55014 Boehringer Ingelheim Investigational Site
city: Curitiba
country: Brazil
facility: 1160.46.55017 Boehringer Ingelheim Investigational Site
city: Porto Alegre
country: Brazil
facility: 1160.46.55019 Boehringer Ingelheim Investigational Site
city: Recife
country: Brazil
facility: 1160.46.55021 Boehringer Ingelheim Investigational Site
city: Rio de Janeiro - RJ
country: Brazil
facility: 1160.46.55016 Boehringer Ingelheim Investigational Site
city: São Bernardo do Campo
country: Brazil
facility: 1160.46.55018 Boehringer Ingelheim Investigational Site
city: São Paulo
country: Brazil
facility: 1160.46.55020 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 1160.46.35901 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 1160.46.35903 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 1160.46.35906 Boehringer Ingelheim Investigational Site
city: Varna
country: Bulgaria
facility: 1160.46.35905 Boehringer Ingelheim Investigational Site
city: Edmonton
country: Canada
facility: 1160.46.02006 Boehringer Ingelheim Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: 1160.46.02013 Boehringer Ingelheim Investigational Site
state: Alberta
city: Victoria
country: Canada
facility: 1160.46.02021 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Saint John
country: Canada
facility: 1160.46.02004 Boehringer Ingelheim Investigational Site
state: New Brunswick
city: Halifax
country: Canada
facility: 1160.46.02001 Boehringer Ingelheim Investigational Site
state: Nova Scotia
city: Hamilton
country: Canada
facility: 1160.46.02002 Boehringer Ingelheim Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: 1160.46.02005 Boehringer Ingelheim Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: 1160.46.02010 Boehringer Ingelheim Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: 1160.46.02015 Boehringer Ingelheim Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: 1160.46.02019 Boehringer Ingelheim Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: 1160.46.02008 Boehringer Ingelheim Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: 1160.46.02009 Boehringer Ingelheim Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: 1160.46.02014 Boehringer Ingelheim Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: 1160.46.02017 Boehringer Ingelheim Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: 1160.46.02020 Boehringer Ingelheim Investigational Site
city: Beijing
country: China
facility: 1160.46.86001 Boehringer Ingelheim Investigational Site
city: Beijing
country: China
facility: 1160.46.86002 Boehringer Ingelheim Investigational Site
city: Beijing
country: China
facility: 1160.46.86019 Boehringer Ingelheim Investigational Site
city: Guangzhou
country: China
facility: 1160.46.86014 Boehringer Ingelheim Investigational Site
city: Guangzhou
country: China
facility: 1160.46.86015 Boehringer Ingelheim Investigational Site
city: Hangzhou
country: China
facility: 1160.46.86016 Boehringer Ingelheim Investigational Site
city: Shanghai
country: China
facility: 1160.46.86003 Boehringer Ingelheim Investigational Site
city: Shanghai
country: China
facility: 1160.46.86004 Boehringer Ingelheim Investigational Site
city: Shanghai
country: China
facility: 1160.46.86005 Boehringer Ingelheim Investigational Site
city: Shanghai
country: China
facility: 1160.46.86011 Boehringer Ingelheim Investigational Site
city: Shenyang
country: China
facility: 1160.46.86007 Boehringer Ingelheim Investigational Site
city: Shijiazhuang
country: China
facility: 1160.46.86017 Boehringer Ingelheim Investigational Site
city: Shijiazhuang
country: China
facility: 1160.46.86018 Boehringer Ingelheim Investigational Site
city: Taiyuan
country: China
facility: 1160.46.86021 Boehringer Ingelheim Investigational Site
city: Tianjin
country: China
facility: 1160.46.86006 Boehringer Ingelheim Investigational Site
city: Yinchuan
country: China
facility: 1160.46.86020 Boehringer Ingelheim Investigational Site
city: Brno
country: Czech Republic
facility: 1160.46.42001 Boehringer Ingelheim Investigational Site
city: Hradec Kralove
country: Czech Republic
facility: 1160.46.42002 Boehringer Ingelheim Investigational Site
city: Liberec
country: Czech Republic
facility: 1160.46.42012 Boehringer Ingelheim Investigational Site
city: Litomerice
country: Czech Republic
facility: 1160.46.42018 Boehringer Ingelheim Investigational Site
city: Novy Jicin
country: Czech Republic
facility: 1160.46.42015 Boehringer Ingelheim Investigational Site
city: Ostrava-Vitkovice
country: Czech Republic
facility: 1160.46.42005 Boehringer Ingelheim Investigational Site
city: Prague 4
country: Czech Republic
facility: 1160.46.42017 Boehringer Ingelheim Investigational Site
city: Tabor
country: Czech Republic
facility: 1160.46.42014 Boehringer Ingelheim Investigational Site
city: Teplice
country: Czech Republic
facility: 1160.46.42016 Boehringer Ingelheim Investigational Site
city: Usti nad Labem
country: Czech Republic
facility: 1160.46.42010 Boehringer Ingelheim Investigational Site
city: Zlin
country: Czech Republic
facility: 1160.46.42007 Boehringer Ingelheim Investigational Site
city: Aarhus C
country: Denmark
facility: 1160.46.45001 Boehringer Ingelheim Investigational Site
city: Esbjerg
country: Denmark
facility: 1160.46.45008 Boehringer Ingelheim Investigational Site
city: Holbæk
country: Denmark
facility: 1160.46.45009 Boehringer Ingelheim Investigational Site
city: København NV
country: Denmark
facility: 1160.46.45004 Boehringer Ingelheim Investigational Site
city: Brest Cedex
country: France
facility: 1160.46.3301A Boehringer Ingelheim Investigational Site
city: Brest Cedex
country: France
facility: 1160.46.3301B Boehringer Ingelheim Investigational Site
city: La Roche-Sur-Yon cedex 09
country: France
facility: 1160.46.3315A Boehringer Ingelheim Investigational Site
city: La Roche-Sur-Yon cedex 09
country: France
facility: 1160.46.3315B Boehringer Ingelheim Investigational Site
city: Nantes
country: France
facility: 1160.46.3313A Boehringer Ingelheim Investigational Site
city: Pessac
country: France
facility: 1160.46.3316A Boehringer Ingelheim Investigational Site
city: Pessac
country: France
facility: 1160.46.3316B Boehringer Ingelheim Investigational Site
city: St Etienne Cedex 2
country: France
facility: 1160.46.3303C Boehringer Ingelheim Investigational Site
city: St Etienne Cedex 2
country: France
facility: 1160.46.3303D Boehringer Ingelheim Investigational Site
city: St Etienne Cedex 2
country: France
facility: 1160.46.3303E Boehringer Ingelheim Investigational Site
city: St Etienne Cedex 2
country: France
facility: 1160.46.3303F Boehringer Ingelheim Investigational Site
city: St Etienne Cedex 2
country: France
facility: 1160.46.3303G Boehringer Ingelheim Investigational Site
city: St Etienne Cedex 2
country: France
facility: 1160.46.3303H Boehringer Ingelheim Investigational Site
city: St Priest En Jarez Cedex
country: France
facility: 1160.46.3303A Boehringer Ingelheim Investigational Site
city: St Priest En Jarez Cedex
country: France
facility: 1160.46.3303B Boehringer Ingelheim Investigational Site
city: Debrecen
country: Hungary
facility: 1160.46.36002 Boehringer Ingelheim Investigational Site
city: Szekesfehervar
country: Hungary
facility: 1160.46.36010 Boehringer Ingelheim Investigational Site
city: Szombathely
country: Hungary
facility: 1160.46.36011 Boehringer Ingelheim Investigational Site
city: Bangalore
country: India
facility: 1160.46.91006 Boehringer Ingelheim Investigational Site
city: Bangalore
country: India
facility: 1160.46.91010 Boehringer Ingelheim Investigational Site
city: Chennai
country: India
facility: 1160.46.91002 Boehringer Ingelheim Investigational Site
city: Chennai
country: India
facility: 1160.46.91007 Boehringer Ingelheim Investigational Site
city: Kolkata
country: India
facility: 1160.46.91012 Boehringer Ingelheim Investigational Site
city: Ludhiana
country: India
facility: 1160.46.91009 Boehringer Ingelheim Investigational Site
city: Nagpur
country: India
facility: 1160.46.91008 Boehringer Ingelheim Investigational Site
city: New Delhi
country: India
facility: 1160.46.91005 Boehringer Ingelheim Investigational Site
city: New Delhi
country: India
facility: 1160.46.91014 Boehringer Ingelheim Investigational Site
city: Pune
country: India
facility: 1160.46.91001 Boehringer Ingelheim Investigational Site
city: Pune
country: India
facility: 1160.46.91004 Boehringer Ingelheim Investigational Site
city: Tamil Nadu
country: India
facility: 1160.46.91011 Boehringer Ingelheim Investigational Site
city: Vadodara
country: India
facility: 1160.46.91013 Boehringer Ingelheim Investigational Site
city: Vadodra
country: India
facility: 1160.46.91003 Boehringer Ingelheim Investigational Site
city: Afula
country: Israel
facility: 1160.46.97202 Boehringer Ingelheim Investigational Site
city: Ashkelon
country: Israel
facility: 1160.46.97207 Boehringer Ingelheim Investigational Site
city: DN Lower Galillee
country: Israel
facility: 1160.46.97212 Boehringer Ingelheim Investigational Site
city: Haifa
country: Israel
facility: 1160.46.97211 Boehringer Ingelheim Investigational Site
city: Holon
country: Israel
facility: 1160.46.97203 Boehringer Ingelheim Investigational Site
city: KfarSaba
country: Israel
facility: 1160.46.97205 Boehringer Ingelheim Investigational Site
city: Nazareth
country: Israel
facility: 1160.46.97209 Boehringer Ingelheim Investigational Site
city: Petah Tiqwa
country: Israel
facility: 1160.46.97206 Boehringer Ingelheim Investigational Site
city: Tel Aviv
country: Israel
facility: 1160.46.97210 Boehringer Ingelheim Investigational Site
city: Tel Hashomer, Ramat Gan
country: Israel
facility: 1160.46.97204 Boehringer Ingelheim Investigational Site
city: Zerifin
country: Israel
facility: 1160.46.97201 Boehringer Ingelheim Investigational Site
city: Catania
country: Italy
facility: 1160.46.39011 Boehringer Ingelheim Investigational Site
city: Firenze
country: Italy
facility: 1160.46.39015 Boehringer Ingelheim Investigational Site
city: Palermo
country: Italy
facility: 1160.46.39012 Boehringer Ingelheim Investigational Site
city: Reggio Emilia
country: Italy
facility: 1160.46.39007 Boehringer Ingelheim Investigational Site
city: Verona
country: Italy
facility: 1160.46.39013 Boehringer Ingelheim Investigational Site
city: Vittorio Veneto (TV)
country: Italy
facility: 1160.46.39005 Boehringer Ingelheim Investigational Site
city: Busan
country: Korea, Republic of
facility: 1160.46.82007 Boehringer Ingelheim Investigational Site
city: Goyang-si
country: Korea, Republic of
facility: 1160.46.82003 Boehringer Ingelheim Investigational Site
city: Gyeonggi-do
country: Korea, Republic of
facility: 1160.46.82008 Boehringer Ingelheim Investigational Site
city: Gyeonggi-do
country: Korea, Republic of
facility: 1160.46.82010 Boehringer Ingelheim Investigational Site
city: Kyunggi-do
country: Korea, Republic of
facility: 1160.46.82002 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1160.46.82004 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1160.46.82005 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1160.46.82006 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1160.46.82009 Boehringer Ingelheim Investigational Site
city: Kelantan Kota Bahru
country: Malaysia
facility: 1160.46.60001 Boehringer Ingelheim Investigational Site
city: Melaka
country: Malaysia
facility: 1160.46.60003 Boehringer Ingelheim Investigational Site
city: Pahang
country: Malaysia
facility: 1160.46.60004 Boehringer Ingelheim Investigational Site
city: Selangor
country: Malaysia
facility: 1160.46.60002 Boehringer Ingelheim Investigational Site
city: Alkmaar
country: Netherlands
facility: 1160.46.31017 Boehringer Ingelheim Investigational Site
city: Amersfoort
country: Netherlands
facility: 1160.46.31001 Boehringer Ingelheim Investigational Site
city: Den Bosch
country: Netherlands
facility: 1160.46.31010 Boehringer Ingelheim Investigational Site
city: Eindhoven
country: Netherlands
facility: 1160.46.31013 Boehringer Ingelheim Investigational Site
city: Heerlen
country: Netherlands
facility: 1160.46.31014 Boehringer Ingelheim Investigational Site
city: Nieuwegein
country: Netherlands
facility: 1160.46.31002 Boehringer Ingelheim Investigational Site
city: Rotterdam
country: Netherlands
facility: 1160.46.31004 Boehringer Ingelheim Investigational Site
city: Zwolle
country: Netherlands
facility: 1160.46.31015 Boehringer Ingelheim Investigational Site
city: Christchurch
country: New Zealand
facility: 1160.46.64004 Boehringer Ingelheim Investigational Site
city: Grafton Auckland
country: New Zealand
facility: 1160.46.64003 Boehringer Ingelheim Investigational Site
city: Otahuhu Auckland
country: New Zealand
facility: 1160.46.64002 Boehringer Ingelheim Investigational Site
city: Takapuna Auckland
country: New Zealand
facility: 1160.46.64001 Boehringer Ingelheim Investigational Site
city: Oslo
country: Norway
facility: 1160.46.47001 Boehringer Ingelheim Investigational Site
city: Trondheim
country: Norway
facility: 1160.46.47005 Boehringer Ingelheim Investigational Site
city: Manila
country: Philippines
facility: 1160.46.63001 Boehringer Ingelheim Investigational Site
city: Muntinlupa
country: Philippines
facility: 1160.46.63005 Boehringer Ingelheim Investigational Site
city: Quezon City
country: Philippines
facility: 1160.46.63003 Boehringer Ingelheim Investigational Site
city: Quezon City
country: Philippines
facility: 1160.46.63004 Boehringer Ingelheim Investigational Site
city: Kielce
country: Poland
facility: 1160.46.48004 Boehringer Ingelheim Investigational Site
city: Krakow
country: Poland
facility: 1160.46.48001 Boehringer Ingelheim Investigational Site
city: Krakow
country: Poland
facility: 1160.46.48005 Boehringer Ingelheim Investigational Site
city: Poznan
country: Poland
facility: 1160.46.48003 Boehringer Ingelheim Investigational Site
city: Warsaw
country: Poland
facility: 1160.46.48006 Boehringer Ingelheim Investigational Site
city: Chelyabinsk
country: Russian Federation
facility: 1160.46.07021 Boehringer Ingelheim Investigational Site
city: Ekaterinburg
country: Russian Federation
facility: 1160.46.07007 Boehringer Ingelheim Investigational Site
city: Krasnodar
country: Russian Federation
facility: 1160.46.07016 Boehringer Ingelheim Investigational Site
city: Kursk
country: Russian Federation
facility: 1160.46.07004 Boehringer Ingelheim Investigational Site
city: Rostov-na-Donu
country: Russian Federation
facility: 1160.46.07009 Boehringer Ingelheim Investigational Site
city: Rostov-na-Donu
country: Russian Federation
facility: 1160.46.07024 Boehringer Ingelheim Investigational Site
city: Ufa
country: Russian Federation
facility: 1160.46.07014 Boehringer Ingelheim Investigational Site
city: Yaroslavl
country: Russian Federation
facility: 1160.46.07005 Boehringer Ingelheim Investigational Site
city: Yaroslavl
country: Russian Federation
facility: 1160.46.07006 Boehringer Ingelheim Investigational Site
city: Singapore
country: Singapore
facility: 1160.46.65001 Boehringer Ingelheim Investigational Site
city: Singapore
country: Singapore
facility: 1160.46.65002 Boehringer Ingelheim Investigational Site
city: Singapore
country: Singapore
facility: 1160.46.65003 Boehringer Ingelheim Investigational Site
city: Banska Bystrica
country: Slovakia
facility: 1160.46.42107 Boehringer Ingelheim Investigational Site
city: Lucenec
country: Slovakia
facility: 1160.46.42106 Boehringer Ingelheim Investigational Site
city: Nitra
country: Slovakia
facility: 1160.46.42102 Boehringer Ingelheim Investigational Site
city: Nove Zamky
country: Slovakia
facility: 1160.46.42103 Boehringer Ingelheim Investigational Site
city: Bryanston
country: South Africa
facility: 1160.46.27001 Boehringer Ingelheim Investigational Site
city: Cape Town
country: South Africa
facility: 1160.46.27013 Boehringer Ingelheim Investigational Site
city: Centurion
country: South Africa
facility: 1160.46.27007 Boehringer Ingelheim Investigational Site
city: Kempton Park
country: South Africa
facility: 1160.46.27014 Boehringer Ingelheim Investigational Site
city: Krugersdorp
country: South Africa
facility: 1160.46.27015 Boehringer Ingelheim Investigational Site
city: Morningside
country: South Africa
facility: 1160.46.27002 Boehringer Ingelheim Investigational Site
city: Plumstead
country: South Africa
facility: 1160.46.27012 Boehringer Ingelheim Investigational Site
city: Sunninghill
country: South Africa
facility: 1160.46.27006 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1160.46.34002 Boehringer Ingelheim Investigational Site
city: Cartagena. Murcia
country: Spain
facility: 1160.46.34007 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1160.46.34009 Boehringer Ingelheim Investigational Site
city: Palma de Mallorca
country: Spain
facility: 1160.46.34015 Boehringer Ingelheim Investigational Site
city: Sabadell - barcelona
country: Spain
facility: 1160.46.34014 Boehringer Ingelheim Investigational Site
city: Valencia
country: Spain
facility: 1160.46.34011 Boehringer Ingelheim Investigational Site
city: Göteborg
country: Sweden
facility: 1160.46.46002 Boehringer Ingelheim Investigational Site
city: Kristianstad
country: Sweden
facility: 1160.46.46010 Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: 1160.46.46001 Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: 1160.46.46008 Boehringer Ingelheim Investigational Site
city: Uppsala
country: Sweden
facility: 1160.46.46003 Boehringer Ingelheim Investigational Site
city: ChangHua
country: Taiwan
facility: 1160.46.88607 Boehringer Ingelheim Investigational Site
city: Taipei
country: Taiwan
facility: 1160.46.88604 Boehringer Ingelheim Investigational Site
city: Taipei
country: Taiwan
facility: 1160.46.88606 Boehringer Ingelheim Investigational Site
city: Taipei
country: Taiwan
facility: 1160.46.88608 Boehringer Ingelheim Investigational Site
city: Taipei
country: Taiwan
facility: 1160.46.88609 Boehringer Ingelheim Investigational Site
city: Bangkok
country: Thailand
facility: 1160.46.66007 Boehringer Ingelheim Investigational Site
city: Bangkok
country: Thailand
facility: 1160.46.66010 Boehringer Ingelheim Investigational Site
city: Khon Kaen
country: Thailand
facility: 1160.46.66001 Boehringer Ingelheim Investigational Site
city: Muang Nakhonratchasima
country: Thailand
facility: 1160.46.66004 Boehringer Ingelheim Investigational Site
city: Nakhonratchasima
country: Thailand
facility: 1160.46.66005 Boehringer Ingelheim Investigational Site
city: Nokorn Nayok
country: Thailand
facility: 1160.46.66006 Boehringer Ingelheim Investigational Site
city: Phayathai
country: Thailand
facility: 1160.46.66008 Boehringer Ingelheim Investigational Site
city: Ankara
country: Turkey
facility: 1160.46.90003 Boehringer Ingelheim Investigational Site
city: Ankara
country: Turkey
facility: 1160.46.90004 Boehringer Ingelheim Investigational Site
city: Istanbul
country: Turkey
facility: 1160.46.90001 Boehringer Ingelheim Investigational Site
city: Istanbul
country: Turkey
facility: 1160.46.90002 Boehringer Ingelheim Investigational Site
city: Istanbul
country: Turkey
facility: 1160.46.90007 Boehringer Ingelheim Investigational Site
city: Istanbul
country: Turkey
facility: 1160.46.90008 Boehringer Ingelheim Investigational Site
city: Istanbul
country: Turkey
facility: 1160.46.90009 Boehringer Ingelheim Investigational Site
city: Istanbul
country: Turkey
facility: 1160.46.90010 Boehringer Ingelheim Investigational Site
city: Vinnitsa
country: Ukraine
facility: 1160.46.38005 Boehringer Ingelheim Investigational Site
city: Headington, Oxford
country: United Kingdom
facility: 1160.46.44005 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 1160.46.44011 Boehringer Ingelheim Investigational Site
city: Newcastle upon Tyne
country: United Kingdom
facility: 1160.46.44006 Boehringer Ingelheim Investigational Site
city: Plymouth
country: United Kingdom
facility: 1160.46.44013 Boehringer Ingelheim Investigational Site
city: Sheffield
country: United Kingdom
facility: 1160.46.44012 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.