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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00680186
Registration number
NCT00680186
Ethics application status
Date submitted
16/05/2008
Date registered
20/05/2008
Date last updated
19/05/2014
Titles & IDs
Public title
Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp Venous Thromboembolism (VTE)
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Scientific 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
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Secondary ID [1]
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2007-002631-86
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Secondary ID [2]
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1160.46
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Universal Trial Number (UTN)
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Trial acronym
RE-COVER II
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Thromboembolism
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0
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Condition category
Condition code
Cardiovascular
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0
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Diseases of the vasculature and circulation including the lymphatic system
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Blood
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0
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Clotting disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Warfarin
Treatment: Drugs - Dabigatran etexilate
Experimental: Dabigatran etexilate (150mg bid) - Patients will receive 1 capsule containing 150 mg dabigatran etexilate/matching placebo twice daily
Active comparator: Warfarin (INR 2.0-3.0) - Patients will receive tablets PRN warfarin/matching placebo to maintain a target INR of 2.0-3.0
Treatment: Drugs: Warfarin
PRN (to maintain a target INR of 2.0-3.0)
Treatment: Drugs: Dabigatran etexilate
150mg bid
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE
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Assessment method [1]
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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.
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Timepoint [1]
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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)
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Secondary outcome [1]
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Number of Participants With Recurrent Symptomatic VTE and All Deaths
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Assessment method [1]
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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.
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Timepoint [1]
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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.
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Secondary outcome [2]
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Number of Participants With Recurrent Symptomatic DVT
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Assessment method [2]
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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.
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Timepoint [2]
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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.
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Secondary outcome [3]
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Number of Participants With Recurrent Symptomatic Non-fatal PE
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Assessment method [3]
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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.
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Timepoint [3]
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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.
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Secondary outcome [4]
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Number of Participants Who Died Due to VTE
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Assessment method [4]
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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.
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Timepoint [4]
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From randomisation to 6 months (up to day 180) and to end of ptp (planned to be up to day 224)
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Secondary outcome [5]
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Number of Participants Who Died (Any Cause)
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Assessment method [5]
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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.
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Timepoint [5]
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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.
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Secondary outcome [6]
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Number of Participants With Recurrent Symptomatic Fatal and Non-fatal PE
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Assessment method [6]
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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.
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Timepoint [6]
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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.
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Secondary outcome [7]
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Number of Participants With MBE, MBE and/or CRBE, and Any Bleeding Events
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Assessment method [7]
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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.
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Timepoint [7]
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From first intake of study drug to last intake of study drug + 6 days washout
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Secondary outcome [8]
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Number of Participants With Acute Coronary Syndrome (ACS)
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Assessment method [8]
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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.
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Timepoint [8]
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From first intake of study drug to last contact date
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Secondary outcome [9]
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Laboratory Analyses
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Assessment method [9]
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Frequency of patients with possible clinically significant abnormalities.
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Timepoint [9]
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From first intake of study drug to last intake of study drug + 6 days washout
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Eligibility
Key inclusion 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
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Accrual to date
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Final
2589
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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1160.46.61007 Boehringer Ingelheim Investigational Site - Concord
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Recruitment hospital [2]
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1160.46.61003 Boehringer Ingelheim Investigational Site - Box Hill
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Recruitment hospital [3]
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1160.46.61001 Boehringer Ingelheim Investigational Site - Clayton
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Recruitment hospital [4]
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1160.46.61006 Boehringer Ingelheim Investigational Site - Windsor
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Recruitment hospital [5]
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1160.46.61005 Boehringer Ingelheim Investigational Site - Perth
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Recruitment postcode(s) [1]
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- Concord
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Recruitment postcode(s) [2]
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- Box Hill
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Recruitment postcode(s) [3]
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- Clayton
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Recruitment postcode(s) [4]
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- Windsor
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Recruitment postcode(s) [5]
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- Perth
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Recruitment outside Australia
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United States of America
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Arkansas
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Florida
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Illinois
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United States of America
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Louisiana
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United States of America
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New York
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Ohio
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Oregon
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South Carolina
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Washington
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Brazil
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Brasília
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Brazil
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Campinas
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Brazil
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Curitiba
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Brazil
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Porto Alegre
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Brazil
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Recife
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Brazil
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Rio de Janeiro - RJ
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Brazil
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São Bernardo do Campo
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São Paulo
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Sofia
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Varna
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Prague 4
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Zlin
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Aarhus C
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Esbjerg
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Holbæk
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København NV
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Brest Cedex
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France
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La Roche-Sur-Yon cedex 09
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Nantes
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France
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Pessac
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France
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St Etienne Cedex 2
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France
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St Priest En Jarez Cedex
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Debrecen
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Hungary
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Szombathely
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India
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Bangalore
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India
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Chennai
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India
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India
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India
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India
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India
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Israel
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Afula
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Israel
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Ashkelon
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Israel
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DN Lower Galillee
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Israel
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Haifa
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Israel
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Holon
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Israel
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KfarSaba
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Israel
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Nazareth
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Israel
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Petah Tiqwa
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Israel
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Tel Aviv
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Israel
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Tel Hashomer, Ramat Gan
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Israel
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Zerifin
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Italy
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Catania
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Italy
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Palermo
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Italy
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Reggio Emilia
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Italy
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Verona
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Italy
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Vittorio Veneto (TV)
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Korea, Republic of
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Busan
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Seoul
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Melaka
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Malaysia
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Alkmaar
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Amersfoort
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Den Bosch
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Eindhoven
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Heerlen
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Christchurch
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New Zealand
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Otahuhu Auckland
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New Zealand
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Takapuna Auckland
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Norway
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Oslo
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Warsaw
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Chelyabinsk
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Russian Federation
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Ekaterinburg
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Russian Federation
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Krasnodar
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Russian Federation
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Russian Federation
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Ufa
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Russian Federation
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Yaroslavl
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Singapore
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Lucenec
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Nitra
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Slovakia
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Nove Zamky
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Bryanston
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South Africa
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Cape Town
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Centurion
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Kempton Park
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South Africa
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Krugersdorp
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South Africa
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Morningside
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South Africa
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Plumstead
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South Africa
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Sunninghill
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Barcelona
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Spain
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Cartagena. Murcia
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Madrid
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Palma de Mallorca
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Spain
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Sabadell - barcelona
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Spain
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Valencia
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Göteborg
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Sweden
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Kristianstad
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Sweden
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Stockholm
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Sweden
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Uppsala
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ChangHua
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Bangkok
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Thailand
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Khon Kaen
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Thailand
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Muang Nakhonratchasima
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Thailand
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Nakhonratchasima
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Thailand
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Nokorn Nayok
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Thailand
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Phayathai
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Turkey
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Ankara
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Turkey
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Istanbul
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Ukraine
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Vinnitsa
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United Kingdom
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Headington, Oxford
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United Kingdom
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London
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United Kingdom
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Newcastle upon Tyne
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United Kingdom
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Plymouth
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United Kingdom
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Sheffield
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Funding & Sponsors
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Commercial sector/industry
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Name
Boehringer Ingelheim
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Address
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00680186
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Trial related presentations / 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. 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.
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Public notes
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Contacts
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Boehringer Ingelheim
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Boehringer Ingelheim
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00680186
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