December 6, 2005 |
April 23, 2009 |
November 2005 |
Incidence of stroke (including hemorrhagic) and systemic embolism [ Time Frame: 3.5 years ] |
Same as current |
Complete list of historical versions of study NCT00262600 on ClinicalTrials.gov Archive Site |
Incidence of stroke (including hemorrhagic), systemic embolism, all death Incidence of stroke (including hemorrhagic), systemic embolism, pulmonary
embolism, acute myocardial infarction, or vascular deaths (including deaths from bleeding) [ Time Frame: 3.4 years ] |
Incidence of stroke (including hemorrhagic), systemic embolism, all death
Incidence of stroke (including hemorrhagic), systemic embolism, pulmonary embolism, acute myocardial infarction, or vascular deaths (including deaths
from bleeding) |
|
Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) With Dabigatran Etexilate |
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) |
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 |
|
Phase III |
Interventional |
Prevention, Parallel Assignment, Safety/Efficacy Study |
- Atrial Fibrillation
- Cerebrovascular Accident
|
- Drug: Dabigatran etexilate
- Drug: Warfarin
|
|
Ezekowitz MD, Connolly S, Parekh A, Reilly PA, Varrone J, Wang S, Oldgren J, Themeles E, Wallentin L, Yusuf S. Rationale and design of RE-LY: randomized evaluation of long-term anticoagulant therapy, warfarin, compared with dabigatran. Am Heart J. 2009 May;157(5):805-10, 810.e1-2. |
|
Active, not recruiting |
18000 |
|
March 2009 (final data collection date for primary outcome measure) |
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.
|
Both |
18 Years and older |
No |
|
United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Korea, Republic of, Malaysia, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom |
|
|
NCT00262600 |
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim |
2005-003894-26 |
Boehringer Ingelheim Pharmaceuticals |
|
Study Chair: |
Boehringer Ingelheim |
Boehringer Ingelheim Pharmaceuticals |
|
|
Boehringer Ingelheim Pharmaceuticals |
April 2009 |