Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) With Dabigatran Etexilate
Condition: Atrial Fibrillation; Stroke
MeSH terms: Atrial Fibrillation
Intervention: warfarin; Dabigatran dose 1; Dabigatran dose 2
Intervention description: once a day; twice daily; twice a day
Intervention MeSH terms: Warfarin; Dabigatran
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Enrollment: 18113.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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.