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Secondary Prevention of Venous Thrombo Embolism (VTE). (RE-MEDY)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00329238
First received: May 23, 2006
Last updated: February 28, 2013
Last verified: February 2013
History of Changes
  Purpose

The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate administered orally and warfarin (International Normalized Ratio (INR) of 2.0-3.0) for the long-term treatment and secondary prevention of symptomatic venous thromboembolism in patients who have been successfully treated with standard doses of an approved anticoagulant for three to twelve months for confirmed acute symptomatic Venous Thrombo-embolism.


Condition Intervention Phase
Thromboembolism
 Drug: Dabigatran
Drug: Warfarin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase III, Randomised, Multicenter, Double-blind, Parallel-group, Active Controlled Study to Evaluate the Efficacy and Safety of Oral Dabigatran Etexilate (150 mg Bid) Compared to Warfarin (INR 2.0-3.0) for the Secondary Prevention of Venous Thromboembolism.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Hazard Ratio for Composite of Recurrent VTE or VTE Death [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Hazard ratio of dabigatran versus warfarin for composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. Hazard ratio of dabigatran versus warfarin was obtained from a Cox proportional hazards model.

  • Risk Difference for Time to First Adjucated Recurrent VTE or VTE Death at Month 18 [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Risk difference of dabigatran versus warfarin at 18 months for composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. Risk differences were estimated using standard Kaplan-Meier estimates.


Secondary Outcome Measures:
  • Hazard Ratio for Composite of Recurrent VTE or All Cause Death [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Hazard ratio of dabigatran versus warfarin for composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. Hazard ratio of dabigatran versus warfarin was obtained from a Cox proportional hazards model.

  • Risk Difference for Time to First Adjucated Recurrent VTE or All Cause Death at Month 18 [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Risk difference of dabigatran versus warfarin at 18 months for composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. Risk differences were estimated using standard Kaplan-Meier estimates.

  • Hazard Ratio for Deep Vein Thrombosis (DVT) During the Planned Treatment Period [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Hazard ratio of dabigatran versus warfarin for deep vein thrombosis. Hazard ratio of dabigatran versus warfarin was obtained from a Cox proportional hazards model.

  • Risk Difference for Time to First Adjucated Recurrent Symptomatic DVT at Month 18 [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Risk difference of dabigatran versus warfarin at 18 months for time to first adjucated recurrent symptomatic DVT. Risk differences were estimated using standard Kaplan-Meier estimates.

  • Hazard Ratio for Symptomatic Pulmonary Embolism (PE) During the Planned Treatment Period [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Hazard ratio of dabigatran versus warfarin for symptomatic pulmonary embolism. Hazard ratio of dabigatran versus warfarin was obtained from a Cox proportional hazards model.

  • Risk Difference for Time to First Adjucated Recurrent Symptomatic Pulmonary Embolism at Month 18 [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Risk difference of dabigatran versus warfarin at 18 months for time to first adjucated recurrent symptomatic pulmonary embolism. Risk differences were estimated using standard Kaplan-Meier estimates.

  • Hazard Ratio for Time to Deaths Related to VTE During the Planned Treatment Period [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Hazard ratio of dabigatran versus warfarin for deaths related to VTE. Hazard ratio of dabigatran versus warfarin was obtained from a Cox proportional hazards model.

  • Risk Difference for Time to Deaths Related to VTE at Month 18 [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Risk difference of dabigatran versus warfarin at 18 months for time to deaths related to VTE. Risk differences were estimated using standard Kaplan-Meier estimates.

  • Hazard Ratio for Time to Deaths of All Causes During the Planned Treatment Period [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Hazard ratio of dabigatran versus warfarin for deaths related to VTE. Hazard ratio of dabigatran versus warfarin was obtained from a Cox proportional hazards model.

  • Risk Difference for Time to Deaths of All Causes at Month 18 [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Risk difference of dabigatran versus warfarin at 18 months for time to deaths of all causes. Risk differences were estimated using standard Kaplan-Meier estimates.


Enrollment: 2867
Study Start Date: May 2006
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dabigatran
Patient to receive 1 capsule containing dabigatran 150 mg twice daily plus placebo tablets for warfarin as decided by sham INR measurements
 Drug: Dabigatran
Dabigatran 150 mg BID (twice daily)
Active Comparator: Warfarin (INR of 2.0-3.0)
Patient to receive warfarin tablets to target INR 2.0-3.0 plus placebo capsules for dabigatran twice daily
 Drug: Warfarin
Warfarin dosed individually to maintain INR 2.0-3.0

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Inclusion_Criteria

  • Acute symptomatic deep vein thrombosis (DVT)
  • Pulmonary embolism (PE) 3-12 months prior to screening, which has been documented by objective testing

Exclusion criteria:

Exclusion_Criteria

  • Symptomatic DVT or PE at screening Interruption of anticoagulant therapy for 2 or more weeks during the 3-12 months of treatment for the prior VTE.
  • Patients who in the investigators judgement are perceived as having an excessive risk of bleeding Elevated Aspartate aminotransferase (AST) or Alanine tranminase (ALT) > 2x ULN
  • Severe renal impairment (estimated creatinine clearance <= 30 ml/min)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00329238

  Show 275 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

No publications provided by Boehringer Ingelheim Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00329238     History of Changes
Other Study ID Numbers: 1160.47, 2005-002536-94
Study First Received: May 23, 2006
Results First Received: August 10, 2011
Last Updated: February 28, 2013
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Dept of Health and Ageing Therapeutic Goods Admin
Austria: Bundesamt für Sicherheit im Gesundheitswesen, A-1030 Vienna
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Brazil: National Health Surveillance Agency
Bulgaria: Bulgarian Drug Agency, BG-1504 Sofia
Canada: Health Canada, Therapeutic Products Directorate
China: Ministry of Health
Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10
Denmark: The Danish Medicines Agency
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: BfArM-Federal Authorities for Drugs and Medical Devices
Great Britain: MHRA
Greece: National Organization for Medicines (EOF) National Ethics Committee
Hungary: National Institute of Pharmacy, H-1051 Budapest
India: Drug Control General of India
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: Comitato Etico delle Aziende Sanitarie dell'Umbria di Perugia
Mexico: Comisión Federal para la Protección contra Riesgos Sanitarios COFEPRIS Federal Commission for Protection against Sanitary Hazards
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
New Zealand: Multicentre Ethics Committee/Medsafe
Norway: Norwegian Medicines Agency (Statens Legemiddelverk)
Poland: Registration Medicinal Product Medical Device Biocidal Product
Portugal: INFARMED - National Authority of Medicines and Health Products, IP
Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow
Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26
South Africa: Medicines Control Council
Spain: Spanish Agency for Medicines and Health Products
Sweden: Medical Products Agency Regional Ethical Review Board
Turkey: Ministry of Health Central Ethics Committee
Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine)
United States: Food and Drug Administration

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
 Thrombosis
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 13, 2013