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) - RE-LY

INTERVENTION: Product Name: dabigatran etexilate Product Code: BIBR 1048 MS Pharmaceutical Form: Capsule, hard INN or Proposed INN: dabigatran etexilate CAS Number: 211915‐06‐9 Current Sponsor code: BIBR 1048 MS Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 110‐ Product Name: dabigatran etexilate Product Code: BIBR 1048 MS Pharmaceutical Form: Capsule, hard INN or Proposed INN: dabigatran etexilate CAS Number: 211915‐06‐9 Current Sponsor code: BIBR 1048 MS Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150‐ Trade Name: Warfarin tablets BP 1 mg Product Name: Warfarin tablets BP 1mg Pharmaceutical Form: Tablet INN or Proposed INN: warfarin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1‐ Trade Name: Warfarin tablets BP 3 mg Product Name: Warfarin tablets BP 3mg Pharmaceutical Form: Tablet INN or Proposed INN: warfarin Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Concentration number: 3‐ Trade Name: Warfarin tablets BP 5 mg Product Name: Warfarin tablets BP 5 mg Pharmaceutical Form: Tablet INN or Proposed INN: warfarin Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Concentration number: 5‐ CONDITION: Prevention of Stroke and Systemic Embolism in patients with Atrial Fibrillation PRIMARY OUTCOME: Main Objective: To demonstrate the efficacy and safety of dabigatran etexilate in patients with non‐valvular atrial fibrillation for the prevention of stroke and systemic embolism. Primary end point(s): Incidence of all stroke (including hemorrhagic) or systemic embolism. Secondary Objective: INCLUSION CRITERIA: Patients are eligible for this study if they meet the following criteria: 1.) AF documented as follows: a. There is ECG documented AF on the day of screening or randomization b. The patient has had a symptomatic episode of paroxysmal or persistent AF documented by 12 lead ECG within six months prior to randomization c. There is documentation of symptomatic or asymptomatic paroxysmal or persistent AF on two separate occasions, at least one day apart, one of which is within six months prior to randomization. In this case, AF may be documented by 12 lead ECG, rhythm strip, pacemaker/ICD electrogram, or Holter ECG. The duration of AF should be at least 30 seconds. Electrograms (not marker channels or mode switch episodes) from pacemakers and defibrillators can be used to document only one episode of paroxysmal or persistent AF 2.) In addition to documented AF, patients must have one of the following additional risk factors for stroke: a. History