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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: November 5, 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
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 ]
    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 ]
    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 ]
    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 ]

    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 ]
    Patients with clinical relevant abnormalities for intracerebral hemorrhage, other intracranial hemorrhage (ICH)

  • Abnormal Liver Function Test [ Time Frame: 36 months ]
    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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00262600

  Show 984 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Population Health Research Institute
Uppsala University
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

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: November 5, 2014

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
Warfarin
Dabigatran
Anticoagulants
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 27, 2017