An Open-label, Randomized, Controlled, Multicenter Study to Evaluate DUAL Antithrombotic Therapy With Rivaroxaban Plus Ticagrelor vs. Rivaroxaban Plus Clopidogrel in Patients With Atrial Fibrillation and Acute Coronary Syndrome
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 4,000
- 主要终点
- The composite endpoints of death and ischemic events
研究概览
简要总结
The study aims to show inferiority of rivaroxaban plus ticagrelor when compared to rivaroxaban plus clopidogrel in terms of safety. Safety will be determined by comparing the rates of death or ischemic event-including myocardial infarction, definite or probable stent thrombosis, stroke, or urgent revascularization.
详细描述
The main objective of this study is to compare a Dual Antithrombotic Therapy (DAT) regimen of rivaroxaban plus ticagrelor with rivaroxaban plus clopidogrel in Patients With Non Valvular Atrial Fibrillation (NVAF) and Acute Coronary Syndrome. The study aims to show inferiority of rivaroxaban plus ticagrelor when compared to rivaroxaban plus clopidogrel in terms of safety. Safety will be determined by comparing the rates of death or ischemic event-including myocardial infarction, definite or probable stent thrombosis, stroke, or urgent revascularization.
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 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with either active or a history of non-valvular atrial fibrillation or flutter with the planned or existing use of an oral anticoagulant for prophylaxis of thromboembolism. In addition, subjects must have had an acute coronary syndrome
- •Planned use of antiplatelet agents for at least 12 months
- •Males and Females ≥ 18 years of age
- •Women of childbearing potential must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug
排除标准
- •Conditions other than atrial fibrillation that require chronic anticoagulation. (e.g. prosthetic mechanical heart valve)
- •Severe renal insufficiency (serum creatinine > 2.5 mg/dL or a calculated creatinine clearance < 30 mL/min
- •Patients with a history of intracranial hemorrhage
- •Patients have had or will undergo Coronary arterial bypass graft (CABG) for their index acute coronary syndrome (ACS) event
- •Patients with known ongoing bleeding and patients with known coagulopathies
- •Any contraindications or allergies to rivaroxaban, or to intended P2Y12 antagonists
- •Have a history of stroke or Transient Ischemic Attack (TIA)
- •Have known significant liver disease or liver function test (LFT) abnormalities
- •Have any severe condition that would limit life expectancy to less than 12 months
研究组 & 干预措施
rivaroxaban plus ticagrelor
rivaroxaban 15 mg (or 10 mg for subjects with moderate renal impairment) once daily plus ticagrelor 90 mg tablet twice daily for 12 months
干预措施: Rivaroxaban 15 MG Oral Tablet (Drug)
rivaroxaban plus ticagrelor
rivaroxaban 15 mg (or 10 mg for subjects with moderate renal impairment) once daily plus ticagrelor 90 mg tablet twice daily for 12 months
干预措施: Ticagrelor 90 MG Oral Tablet (Drug)
rivaroxaban plus clopidogrel
rivaroxaban 15 mg (or 10 mg for subjects with moderate renal impairment) once daily plus clopidogrel 75 mg tablet once daily for 12 months
干预措施: Rivaroxaban 15 MG Oral Tablet (Drug)
rivaroxaban plus clopidogrel
rivaroxaban 15 mg (or 10 mg for subjects with moderate renal impairment) once daily plus clopidogrel 75 mg tablet once daily for 12 months
干预措施: Clopidogrel 75 Mg Oral Tablet (Drug)
结局指标
主要结局
The composite endpoints of death and ischemic events
时间窗: one year
The composite endpoints of death and ischemic events (stroke, myocardial infarction, stent thrombosis, urgent revascularization )
次要结局
- Clinically significant bleeding(one year)
研究者
Jian'an Wang,MD,PhD
President of Second Affiliated Hospital, School of Medicine, Zhejiang University & Chief of Cardiology
Second Affiliated Hospital, School of Medicine, Zhejiang University