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Efficacy and Safety of Dabigatran Compared to Warfarin for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism (RE-COVER I)

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ClinicalTrials.gov Identifier: NCT00291330
Recruitment Status : Completed
First Posted : February 14, 2006
Results First Posted : February 11, 2011
Last Update Posted : June 6, 2014
Sponsor:
Information provided by:

February 13, 2006
February 14, 2006
November 18, 2010
February 11, 2011
June 6, 2014
February 2006
May 2009   (Final data collection date for primary outcome measure)
Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE [ Time Frame: For statistical analysis 1: from randomisation to end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180) ]
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.
Composite of recurrent symptomatic venous thrombembolism (VTE) and deaths related to VTE within 6 months. VTE is defined as the composite incidence of deep vein thrombosis (DVT) of the leg and pulmonary embolism (PE).
Complete list of historical versions of study NCT00291330 on ClinicalTrials.gov Archive Site
  • Number of Participants With Recurrent Symptomatic VTE and All Deaths [ Time Frame: For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224. ]

    VTE or any death which occured from randomisation to end of post treatment period.

    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.

  • Number of Participants With Recurrent Symptomatic DVT [ Time Frame: For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224. ]

    Symptomatic DVT which occured from randomisation to end of post treatment period.

    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.

  • Number of Participants With Recurrent Symptomatic Non-fatal PE [ Time Frame: For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224. ]

    Symptomatic non-fatal PE which occured from randomisation to end of post treatment period.

    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.

  • Number of Participants Who Died Due to VTE [ Time Frame: For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224. ]

    VTE - related deaths which occured from randomisation to end of post treatment period.

    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.

  • Number of Participants Who Died (Any Cause) [ Time Frame: For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224. ]
    Any deaths which occured from randomisation to end of post treatment period. 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.
  • Number of Participants With Bleeding Events [ Time Frame: From first intake of study drug to last intake of study drug + 6 days washout (washout time can be reduced until 0 day if the patient takes an other anti−coagulant therapy on and after last intake of active study drug) ]

    Major bleeding events (MBE) were 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) was defined as

    • spontaneous skin hematoma >=25 cm²
    • spontaneous nose bleed >5 min
    • macroscopic hematuria spontaneous or >24 hours if associated with an intervention
    • spontaneous rectal bleeding (more than spotting on toilet paper)
    • 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.

  • Number of Participants With Acute Coronary Syndrome (ACS) [ Time Frame: From first intake of study drug to end of study conduct ]

    Any ACS occurring during the conduct of the study (centrally adjudicated as definite).

    Counts of patients having a centrally adjudicated definite ACS during intake of active study drug, after stopping active study drug and before or without intake of active study drug, according to treatment group.

    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.

  • Laboratory Analyses [ Time Frame: From first intake of study drug to last intake of study drug + 6 days washout (washout time can be reduced until 0 day if the patient takes an other anti−coagulant therapy on and after last intake of active study drug) ]
    Frequency of patients with possible clinically significant abnormalities.
Composite of recurrent symptomatic VTE and all deaths, symptomatic DVT, symptomatic PE, deaths related to VTE and all deaths. Bleeds, adverse events (AEs), discontinuation due to AEs, laboratory measures, Acute Coronary Syndromes, ECG and vital signs.
Not Provided
Not Provided
 
Efficacy and Safety of Dabigatran Compared to Warfarin for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism
A Phase III, Randomised, Double Blind, Parallel-group Study of the Efficacy and Safety of Oral Dabigatran Etexilate 150 mg Twice Daily Compared to Warfarin (INR 2.0-3.0) for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism (VTE), Following Initial Treatment (5-10 Days) With a Parenteral Anticoagulant Approved for This Indication.
The purpose of this trial is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin as needed (pro re nata - prn) to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic venous thromboembolism (VTE), following initial treatment (5-10 days) with a parenteral anticoagulant approved for this indication. This trial aims to demonstrate non-inferiority of dabigatran compared with warfarin in patients with acute symptomatic VTE. After achieving non-inferiority, this trial also aims to establish superiority (by means of hierarchical tests) of dabigatran over warfarin.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Thromboembolism
  • Drug: dabigatran etexilate 150 mg
    twice daily
  • Drug: warfarin (INR 2-3)
    prn to maintain INR (2-3)
  • Experimental: dabigatran etexilate 150 mg
    twice daily
    Intervention: Drug: dabigatran etexilate 150 mg
  • Active Comparator: warfarin (INR 2-3)
    prn to maintain INR (2-3)
    Intervention: Drug: warfarin (INR 2-3)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2564
Not Provided
May 2009   (Final data collection date for primary outcome measure)

Inclusion criteria

  1. Acute deep vein thrombosis (DVT) of the leg involving proximal veins, and/or pulmonary embolism (PE) iin patients for whom at least 6 months of anticoagulant therapy is considered appropriate
  2. Male or female, being 18 years of age or older
  3. Written informed consent for study participation

Exclusion criteria

  1. Overt symptoms of VTE for longer than 2 weeks prior to enrolment
  2. PE satisfying at least one of the following criteria: Haemodynamic instability, embolectomy is indicated or performed, thrombolytic therapy is indicated or performed, or suspected source of PE is other than the legs
  3. Actual or anticipated use of vena cava filter
  4. Contraindications to anticoagulant therapy
  5. Patients who in the investigators opinion should not be treated with warfarin
  6. Allergy to heparins or other alternate approved therapy used for initial treatment, warfarin or dabigatran, or to one of the excipients included in these medications
  7. Patients who in the investigators judgement are perceived as having an excessive risk of bleeding
  8. Known anaemia
  9. Need of anticoagulant treatment for disorders other than VTE
  10. Recent unstable cardiovascular disease
  11. Elevated AST or ALT > 2x ULN
  12. Liver disease expected to have any potential impact on survival
  13. Patients who have developed transaminase elevations upon exposure to ximelagatran
  14. Severe renal impairment
  15. Women who are pregnant, nursing, or of childbearing potential who refuse to use a medically acceptable form of contraception
  16. Participation in another clinical trial with an investigational drug during the last 30 days or previous participation in this study
  17. Patients considered unsuitable for inclusion by the investigator
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Hungary,   India,   Israel,   Italy,   Mexico,   Netherlands,   New Zealand,   Norway,   Portugal,   Russian Federation,   Slovakia,   South Africa,   Spain,   Sweden,   Turkey,   Ukraine,   United Kingdom,   United States
Finland
 
NCT00291330
1160.53
2005-001999-12 ( EudraCT Number: EudraCT )
Not Provided
Not Provided
Not Provided
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP