Status:
COMPLETED
Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) With Dabigatran Etexilate
Lead Sponsor:
Boehringer Ingelheim
Collaborating Sponsors:
Population Health Research Institute
Uppsala University
Conditions:
Atrial Fibrillation
Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 emboli...
Eligibility Criteria
Inclusion
- 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
- 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
- Severe, disabling stroke within the previous 6 months, or any stroke within the previous 14 days
- Conditions associated with an increased risk of bleeding
- Contraindication to warfarin treatment
- Reversible causes of atrial fibrillation (e.g., cardiac surgery, pulmonary embolism, untreated hyperthyroidism).
- Plan to perform a pulmonary vein ablation or surgery for cure of the AF
- Severe renal impairment (estimated creatinine clearance \<=30 mL/min)
- Active infective endocarditis
- Active liver disease
- Women who are pregnant, lactating, or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study
- Anaemia (haemoglobin \<100g/L) or thrombocytopenia (platelet count \<100 x 109/L)
- Patients who have developed transaminase elevations upon exposure to ximelagatran
- Patients who have received an investigational drug in the past 30 days or are participating in another drug study
- 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)
- Any known hypersensitivity to galactose if the warfarin used contains galactose.
Exclusion
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
18113 Patients enrolled
Trial Details
Trial ID
NCT00262600
Start Date
December 1 2005
Last Update
April 17 2019
Active Locations (984)
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1
1160.26.0009 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
2
1160.26.0046 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
3
1160.26.0057 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
4
1160.26.0211 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States