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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00262600
Recruitment Status : Completed
First Posted : December 7, 2005
Results First Posted : February 10, 2011
Last Update Posted : April 17, 2019
Sponsor:
Collaborators:
Population Health Research Institute
Uppsala University
Information provided by:
Boehringer Ingelheim

Brief Summary:
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 or disease Intervention/treatment Phase
Atrial Fibrillation Stroke Drug: warfarin Drug: Dabigatran dose 1 Drug: Dabigatran dose 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18113 participants
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)
Actual Study Start Date : December 2005
Actual Primary Completion Date : April 2009


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. 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

  2. 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

  3. 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.


  4. 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)

  5. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00262600


Locations
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Sponsors and Collaborators
Boehringer Ingelheim
Population Health Research Institute
Uppsala University
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00262600    
Other Study ID Numbers: 1160.26
2005-003894-26 ( EudraCT Number: EudraCT )
First Posted: December 7, 2005    Key Record Dates
Results First Posted: February 10, 2011
Last Update Posted: April 17, 2019
Last Verified: April 2014
Additional relevant MeSH terms:
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Atrial Fibrillation
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Warfarin
Dabigatran
Anticoagulants
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action