Rivaroxaban in Patients With Atrial Fibrillation and Coronary Artery Disease Undergoing Percutaneous Coronary Intervention
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- Major or clinically relevant non-major bleeding
研究概览
简要总结
To evaluate the safety for the combination of Rivaroxaban and Ticagrel versus triple antithrombotic regimen (Vitamin K Antagonist (VKA), Clopigogrel and Aspirin) in patients with atrial fibrillation and coronary artery disease undergoing percutaneous coronary intervention (PCI).
详细描述
This is an open-label (both physician and participant know the treatment that the participant receives), randomized (study medication is assigned by chance), multicenter clinical study assessing the safety of the combination of rivaroxaban and ticagrel versus triple antithrombotic regimen (warfarin, clopigogrel and aspirin) in patients, who have paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF) and concomitant coronary artery disease undergoing percutaneous coronary intervention (PCI). A target of 420 participants will be randomized into the study, with approximately 210 participants in each treatment strategy group. Primary comparisons will be made of the rates of major and clinically relevant bleeding, assessed by the modified International Society of Thrombosis and Haemostasis (ISTH) classification. The study consists of a screening phase, a 12-month open-label treatment phase, and an end-of-treatment/early withdrawal visit. The total duration of participation in the study for each participant is approximately 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a long-term indication for oral anticoagulation treatment (until at least 1 year after the study)
- •a severe coronary lesion (at least 75% stenosis on angiography or fractional flow reserve lower than 0•80) with indication for PCI
- •age 18-80 years
排除标准
- •history of intracranial bleeding;
- •cardiogenic shock;
- •contra indication to use of antiplatelet or anticoagulation drugs;
- •peptic ulcer in the previous 6 months;
- •thrombo cytopenia (platelet concentration lower than 50~10⁹/L);
- •major bleeding (according to the Thrombolysis in Myocardial Infarction [TIMI] criteria) in the past 12 months; and
- •pregnancy.
研究组 & 干预措施
Dual antithrombotic therapy (DAT)
Dual Antithrombotic Therapy (DAT) regimen of rivaroxaban 2.5mg/5mg b.i.d. plus ticagrelor 90mg b.i.d.
干预措施: rivaroxaban and ticagrel therapy (Drug)
Triple antithrombotic therapy (TAT)
Triple antithrombotic therapy (TAT) regimen of aspirin 100mg q.d., clopidogrel 75mg q.d. plus warfarin (INR 1.8-2.5).
干预措施: triple antithrombotic regimen with warfarin, asipirin and clopidogrel (Drug)
结局指标
主要结局
Major or clinically relevant non-major bleeding
时间窗: 12 months
Major bleeding was assessed by the International Society of Thrombosis and Hemostasis (ISTH) definition. It included bleeding that was fatal, occurred in a critical location (intracranial, intraspinal, intraocular, retroperitoneal, intraarticular, intramuscular with compartment syndrome, or pericardial), or was associated with a fall in hemoglobin of 2 g/dL or a transfusion of 2 units of packed red blood cells. Clinically relevant non-major bleeding was defined as bleeding that required medical or surgical intervention.
次要结局
- Composite outcome of death, myocardial infarction, stent thrombosis and ischemic stroke(12 months)
研究者
Yujie Zhou
Vice President of Beijing Anzhen Hospital, Capital Medical University
Beijing Anzhen Hospital