Registry for Estimation of Warfarin and Rivaroxaban in Atrial Fibrillation Patients With Coronary Stent Implantation (REWRAPS)
- Conditions
- Atrial fibrillation, Coronary artery disease
- Registration Number
- JPRN-UMIN000016873
- Lead Sponsor
- Fujita Health University, Department of Cardiology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 300
Not provided
Those in whom the package inserts state anticoagulant drugs are contraindicated for use Those who are scheduled to undergo percutaneous coronary intervention or catheter ablation for AF Those who have to continuously undergo dual antiplatelet due to a past history of stent thrombosis during the distant stage after stenting Those who have undergone prosthetic valve replacement for valvular disease Those who the physician in charge judges are ineligible for the study due to serious pathological conditions Those who have moderate renal insufficiency (creatinine clearance less than 30 ml/min) Those who have severe hepatic insufficiency [ALT more than five times the upper limit of normal (ULN), or ALT more than three times ULN, plus total bilirubin more than three times ULN] Those who have anemia (hemoglobin less than 10 g/dl) Those who are not willing to participate in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy; composite of adverse events [cardiac or stroke death, non-fatal myocardial infarction, non-fatal stroke, and coronary artery revascularization (percutaneous coronary intervention or coronary artery bypass graft), and systemic embolism] Safety; major bleeding or non-major clinically relevant bleeding
- Secondary Outcome Measures
Name Time Method All-cause death non-fatal myocardial infarction coronary artery revascularization (percutaneous coronary intervention or coronary artery bypass graft) admission due to congestive heart failure fatal arrhythmia non-fatal stroke systemic embolism stent thrombosis major bleeding non-major clinical relevant bleeding electrocardiographic findings rhythm, ST change, Q wave abnormality, QRS duration, QT interval, QTc interval, the presence of supraventricular premature contraction (SVPC), the presence of ventricular premature contraction (VPC) cardiac ultrasound findings left atrial dilatation (LAD), left ventricular end-diastolic diameter (LVDd), left ventricular end-systolic diameter (LVDs), E/A, tricuspid regurgitation pressure gradient (TRPG), LV wall abnormality