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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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)
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
Secondary ID [1] 0 0
2007-002631-86
Secondary ID [2] 0 0
1160.46
Universal Trial Number (UTN)
Trial acronym
RE-COVER II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Thromboembolism 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
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 outcome [1] 0 0
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.
Timepoint [1] 0 0
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.
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
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.
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
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.
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
From randomisation to 6 months (up to day 180) and to end of ptp (planned to be up to day 224)
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
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.
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
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.
Secondary outcome [7] 0 0
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.
Timepoint [7] 0 0
From first intake of study drug to last intake of study drug + 6 days washout
Secondary outcome [8] 0 0
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.
Timepoint [8] 0 0
From first intake of study drug to last contact date
Secondary outcome [9] 0 0
Laboratory Analyses - Frequency of patients with possible clinically significant abnormalities.
Timepoint [9] 0 0
From first intake of study drug to last intake of study drug + 6 days washout

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
1160.46.61007 Boehringer Ingelheim Investigational Site - Concord
Recruitment hospital [2] 0 0
1160.46.61003 Boehringer Ingelheim Investigational Site - Box Hill
Recruitment hospital [3] 0 0
1160.46.61001 Boehringer Ingelheim Investigational Site - Clayton
Recruitment hospital [4] 0 0
1160.46.61006 Boehringer Ingelheim Investigational Site - Windsor
Recruitment hospital [5] 0 0
1160.46.61005 Boehringer Ingelheim Investigational Site - Perth
Recruitment postcode(s) [1] 0 0
- Concord
Recruitment postcode(s) [2] 0 0
- Box Hill
Recruitment postcode(s) [3] 0 0
- Clayton
Recruitment postcode(s) [4] 0 0
- Windsor
Recruitment postcode(s) [5] 0 0
- Perth
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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Louisiana
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New York
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Valencia
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Uppsala
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ChangHua
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Taipei
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Bangkok
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Muang 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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London
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Plymouth
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Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00680186
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications