Our study
RE-LYa[1]
ROCKET-AFb[2]
ARISTOTLEc[4]
ENGAGE TIMI48d[5]
Inclusion
Age ≥ 18 years ≥ 18 years ≥ 18 years ≥ 18 years ≥ 21 years
AF Non-valvular atrial fibrillation Atrial fibrillation Non-valvular atrial fibrillation Atrial fibrillation or atrial flutter Paroxysmal, persistent, or permanent AF
CHADS2 Score
CHADS2 score ≥ 2
One of the following: 1. Prior stroke, TIA or SE 2. EF<40% 3. HF 4. Age≥75. 5. 65≦age<75&(DM or HT or CAD)
CHADS2 score ≥ 2
CHADS2 score ≥ 1
CHADS2 score ≥ 2
Exclusion
Bleeding Risk History of major bleeding History of major bleeding History of major bleeding N/A History of major bleeding
Uncontrolled hypertension
SBP >180mmHg or DBP >100mmHg SBP > 180mmHg and/or DBP > 100mmHg SBP ≥ 180mmHg or DBP ≥ 100mmHg SBP >180mmHg or DBP > 100mmHg SBP > 170mmHg or DBP > 100mmHg
Renal function Calculated CLCR < 30 mL/min Calculated CLCR ≤ 30 mL/min Calculated CLCR < 30 mL/min Serum creatinine > 2.5 mg/dL or a calculated CLCR < 25 Calculated CLCR < 30 mL/min
Hepatic function
ALT or AST > 2x the ULN, or TBL ≥ 1.5x the ULN
Active liver disease, including but not limited to a. persistent ALT, AST, Alk Phos > 2x the ULN
Known significant liver disease, or ALT > 3x the ULN
ALT or AST > 2x the ULN, or a Total Bilirubin ≥ 1.5x the ULN
Active or persistent liver disease, positive hepatitis B to C test, in: ・ALT or AST ≥ 2x the ULN ・TBL ≥ 1.5x the ULN
Haemoglobin & platelet count
Hgb < 10 g/dL or platelet count < 100,000 cells/mL
Hgb < 10 g/dL or platelet count < 100,000 cells/mL
Hgb < 10 g/dL or platelet count < 90,000 cells/mL
Hgb < 9 g/dL or platelet count ≤ 100,000 cells/mL
Hgb < 10 g/dL or platelet count < 100,000 cells/mL or WBC < 3000cell/mL
Antiplatelet therapy Aspirin in combination with thienopyridines N/A Aspirin > 100 mg/day or Aspirin in combination with thienopyridines Aspirin > 165 mg/day or Aspirin in combination with thienopyridines Aspirin in combination with thienopyridines
Anti-inflammatory agents Chronic treatment with NSAIDs N/A Anticipated need for chronic treatment with NSAIDs N/A Chronic treatment with NSAIDs
Concomitant Therapy
N/A
CYP3A4 inducer CYP3A4 inhibitor CYP3A4 inhibitor Macrolide antibiotics
Cox-2 inhibitor
Drug or alcohol dependence Alcohol dependence N/A Drug addiction or alcohol dependence Drug addiction or alcohol dependence Drug addiction or alcohol dependence