Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) With Dabigatran Etexilate

This study has been completed.
Sponsor:
Collaborators:
Population Health Research Institute
Uppsala University
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00262600
First received: December 6, 2005
Last updated: April 25, 2014
Last verified: April 2014
  Purpose

The primary objective of this trial is to demonstrate the efficacy and safety of dabigatran etexilate in patients with non-valvular atrial fibrillation for the prevention of stroke and systemic embolism.


Condition Intervention Phase
Atrial Fibrillation
Stroke
Drug: warfarin
Drug: Dabigatran dose 1
Drug: Dabigatran dose 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
Official Title: Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) Comparing the Efficacy and Safety of Two Blinded Doses of Dabigatran Etexilate With Open Label Warfarin for the Prevention of Stroke and Systemic Embolism in Patients With Non-valvular Atrial Fibrillation: Prospective, Multi-centre, Parallel-group, Non-inferiority Trial (RE-LY Study)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Yearly Event Rate for Composite Endpoint of Stroke/SEE [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Time to first occurrence of stroke or systemic embolic event. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25


Secondary Outcome Measures:
  • Yearly Event Rate for Composite Endpoint of Stroke/SEE/All Cause Death [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Time to first occurrence of stroke, SEE or all cause death. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25

  • Yearly Event Rate: Composite of Stroke/SEE/PE/MI/Vascular Death [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Time to first occurrence of stroke, systemic embolic event, pulmonary embolism, myocardial infarction including silent myocardial infarction or vascular death. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25

  • Bleeding Events (Major and Minor) [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

    Yearly event rate of bleeds. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25

    Major bleeds are adjudicated, whereas minor bleeds are investigator reported.


  • Clinical Relevant Abnormalities for Intracerebral Hemorrhage and Other Intracranial Hemorrhage (ICH) [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Patients with clinical relevant abnormalities for intracerebral hemorrhage, other intracranial hemorrhage (ICH)

  • Abnormal Liver Function Test [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Number of subjects with abnormal liver function test (LFT), i.e., ALT/AST>3xULN and total bilirubin > 2 x ULN


Enrollment: 18113
Study Start Date: November 2005
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dabigatran dose 2
twice a day
Drug: Dabigatran dose 2
twice a day
Active Comparator: Warfarin
once a day
Drug: warfarin
once a day
Active Comparator: Dabigatran dose 1
twice a day
Drug: Dabigatran dose 1
twice daily

  Eligibility

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

Inclusion criteria Patients with non-valvular atrial fibrillation (AF), at moderate to high risk of stroke, or systemic embolism with at least one additional risk factor (i.e. previous ischemic stroke, TIA, or systemic embolism, left ventricular dysfunction, age >=75 years, age >=65 with either diabetes mellitus, history of coronary artery disease or hypertension)

Exclusion criteria

  1. Prosthetic heart valves requiring anticoagulation per se, or hemodynamically relevant valve disease that is expected to require surgical intervention during the course of the study
  2. Severe, disabling stroke within the previous 6 months, or any stroke within the previous 14 days
  3. Conditions associated with an increased risk of bleeding
  4. Contraindication to warfarin treatment
  5. Reversible causes of atrial fibrillation (e.g., cardiac surgery, pulmonary embolism, untreated hyperthyroidism).
  6. Plan to perform a pulmonary vein ablation or surgery for cure of the AF
  7. Severe renal impairment (estimated creatinine clearance <=30 mL/min)
  8. Active infective endocarditis
  9. Active liver disease
  10. Women who are pregnant, lactating, or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study
  11. Anaemia (haemoglobin <100g/L) or thrombocytopenia (platelet count <100 x 109/L)
  12. Patients who have developed transaminase elevations upon exposure to ximelagatran
  13. Patients who have received an investigational drug in the past 30 days or are participating in another drug study
  14. Patients considered unreliable by the investigator concerning the requirements for follow-up during the study and/or compliance with study drug administration, has a life expectancy less than the expected duration of the trial due to concomitant disease, or has any condition which in the opinion of the investigator, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse)
  15. Any known hypersensitivity to galactose if the warfarin used contains galactose.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00262600

  Show 952 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Population Health Research Institute
Uppsala University
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

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

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00262600     History of Changes
Other Study ID Numbers: 1160.26, 2005-003894-26
Study First Received: December 6, 2005
Results First Received: November 18, 2010
Last Updated: April 25, 2014
Health Authority: Argentina: A.N.M.A.T. (Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica)
Australia: Responsilble Ethics Committee
Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Brazil: National Health Surveillance Agency
Bulgaria: Bulgarian Drug Agency, BG-1504 Sofia
Canada: Health Canada
China: Food and Drug Administration
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
France: AFFSAPS
Germany: Federal Institute for Drugs and Medical Devices
Great Britain: MHRA
Greece: National Organization for Medicines (EOF) National Ethics Committee
Hong Kong: Department of Health
Hungary: National Institute of Pharmacy, H-1051 Budapest
India: Drug Control General of India
Israel: Ministry of Health
Italy: Comitato Etico Indipendente - BOLOGNA
Japan: Ministry of Health, Labor and Welfare
Korea, Republic of: KOREA Food and Drug Administration (KFDA)
Malaysia: Drug Control Authority
Mexico: Federal Commission for Sanitary Risks Protection
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Norway: Norwegian Medicines Agency (Statens Legemiddelverk)
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Philippines: Bureau of Food and Drug
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: INFARMED, National Authority of Medicines and Health Products, IP
Romania: National Medicines Agency, Bucharest
Russia: Ministry of Health of the Russian Federation
Singapore: Health Sciences Authority
Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26
South Africa: MCC
Spain: Agencia Española del Medicamento y Productos Sanitarios
Sweden: Medical Products Agency
Switzerland: Swissmedic
Taiwan: Department of Health, Executive Yuan, Taiwan
Thailand: Thai Food & Drug Administration
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:
Stroke
Atrial Fibrillation
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Dabigatran
Anticoagulants
Warfarin
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014