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)

Criterios de exclusión

• 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.