Assessment of Dual antiplatelet therapy versus Rivaroxaban In atrial Fibrillation patients Treated with left atrial appendage closure: The randomized ADRIFT Study

INTERVENTION: Trade Name: Xarelto 10mg Product Name: Xarelto 10mg Pharmaceutical Form: Tablet INN or Proposed INN: rivaroxaban Other descriptive name: rivaroxaban Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10‐ Trade Name: Xarelto 15 mg Product Name: Xarelto 15 mg Pharmaceutical Form: Tablet INN or Proposed INN: rivaroxaban Other descriptive name: rivaroxaban Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15‐ Trade Name: Kardegic Product Name: Kardegic Pharmaceutical Form: Powder for oral solution INN or Proposed INN: acide acétylsalicylique Other descriptive name: acide acétylsalicylique Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75‐ Trade Name: Plavix 75 mg Product Name: Plavix 75 mg Pharmaceutical Form: Tablet INN or Proposed INN: clopidogrel Other descriptive name: clopidogrel Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75‐ CONDITION: ; MedDRA version: 19.1 Level: PT Classification code 10003658 Term: Atrial fibrillation System Organ Class: 10007541 ‐ Cardiac disorders Therapeutic area: Diseases [C] ‐ Cardiovascular Diseases [C14] PRIMARY OUTCOME: Main Objective: Primary end point(s): Secondary Objective: INCLUSION CRITERIA: Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80