Rivaroxaban Estimation With Warfarin in Atrial Fibrillation Patients With Coronary Stent Implantation Study (REWRAPS)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- a composite of adverse events
研究概览
简要总结
Antiplatelet therapy is indispensable for the prevention of stent thrombosis in patients who underwent coronary artery stenting. Similarly, anticoagulant therapy is essential for the prevention of cardiogenic embolism including cerebral infarction in AF patients. However, the combined antithrombotic therapy has been reported to increase the risk of major bleeding for AF patients after coronary stenting, New anticoagulant drugs that hardly interact with other drugs and do not need frequent blood tests have become commonly used. The purpose of this study is to assess the hypothesis that Rivaroxaban is non-inferior to Warfarin in the efficacy and safety for AF patients after coronary stenting
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically stable atrial fibrillation (AF) patients who underwent coronary artery stenting more than one year ago and are treated or are scheduled to be treated with anticoagulant drug (regardless of the type of stents and AF).
- •Those who are willing to cooperate with us in the study. Those who can sign the informed consent document that is approved by the ethics committee of the medical institution participating in the study.
排除标准
- •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 are not willing to participate in the study.
研究组 & 干预措施
Rivaroxaban
Patients were treated over a median of 4.75 years with either rivaroxaban (10 mg once daily for patients with a creatinine clearance of 15-49 mL/min or 15 mg once daily for patients with a creatinine clearance ≥50 mL/min)
干预措施: Rivaroxaban or Warfarin (Drug)
Warfarin
The dose of warfarin can be controlled with dose adjustment to achieve a target international normalized ratio [INR] of 2.0-3.0 or in patients aged >70 years and having a high bleeding risk, a target INR of 1.6-2.6) according to the guideline of Japanese Circulation Society based on the following paper (Inoue H, Okumura K, Atarashi H, Yamashita T, Origasa H, Kumagai N, et al. Target international normalized ratio values for preventing thromboembolic and hemorrhagic events in Japanese patients with non-valvular atrial fibrillation: results of the J-RHYTHM Registry. Circ J 2013;77(9):2264-70.)
干预措施: Rivaroxaban or Warfarin (Drug)
结局指标
主要结局
a composite of adverse events
时间窗: 3 years
cardiac or stroke death, non-fatal myocardial infarction, non-fatal stroke, coronary artery revascularization (percutaneous coronary intervention or coronary artery bypass graft), and systemic embolism
Net Adverse Clinical Event (NACE)
时间窗: 3 years
a composite of all-cause death and major bleeding
major bleeding
时间窗: 3 years
BARC 3 and 5
次要结局
- fatal arrhythmia(3 years)
- non-fatal myocardial infarction(3 years)
- all-cause death(3 years)
- cardiac or stroke death(3 years)
- admission due to congestive heart failure(3 years)
- electrocardiographic findings(3 years)
- each cardiovascular event used for the primary efficacy outcome measures(3 years)
- non-fatal stroke(3 years)
- non-major clinical relevant bleeding(3 years)
- coronary artery revascularization (percutaneous coronary intervention or coronary artery bypass graft)(3 years)
- cardiac ultrasound findings(3 years)
- systemic embolism(3 years)
研究者
Yukio Ozaki
Department of Cardiology, Fujita Health University
Fujita Health University