Ticagrelor Monotherapy in PAtients Treated With New-generation Drug-eluting Stents for Acute Coronary Syndrome; T-PASS Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,850
- 试验地点
- 1
- 主要终点
- Net clinical benefit
研究概览
简要总结
We hypothesized that ticagrelor monotherapy might be enough to prevent thromboembolic events without aspirin after PCI in patients with acute coronary syndrome(ACS). Moreover, ticagrelor monotherapy will reduce bleeding risk compared to DAPT with aspirin plus ticagrelor. We will also evaluate 1-year safety and efficacy of Orsiro stent for patient with acute coronary syndrome. After confirmation of enrollment, patients will be randomized to continue standard treatment (aspirin plus ticagrelor) for 1 year or to stop aspirin after discharge or less than 1 month after PCI (ticagrelor monotherapy). Randomization will be stratified according to 1) the presence of diabetes and 2) ST elevation myocardial infarction (MI). Baseline clinical and angiographic characteristics, laboratory findings will be assessed at the time of randomization. All patients will provide informed consent on their own initiative.
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
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥19 years old
- •Patients who received new generation sirolimus-eluting (Orsiro® series) stent implantation for treating ACS, including acute MI and unstable angina
- •Provision of informed consent
排除标准
- •Age> 80 years
- •Increased risk of bleeding, anemia, thrombocytopenia
- •A need for oral anticoagulation therapy
- •Pregnant women or women with potential childbearing
- •Life expectancy < 1 year
研究组 & 干预措施
Standard DAPT
Patient will continue standard treatment (aspirin plus ticagrelor) for 1 year. Dosage of ticagrelor would be 90 mg twice a day, and 100 mg of aspirin will be prescribed once a day.
干预措施: Standard DAPT (Drug)
Very-short DAPT within 1 month
Patient will stop aspirin after discharge (DAPT less than 1 months after PCI) (ticagrelor monotherapy). Dosage of ticagrelor would be 90 mg twice a day, and 100 mg of aspirin will be prescribed once a day (during hospitalization).
干预措施: Very-short DAPT less than 1 month after PCI (Drug)
结局指标
主要结局
Net clinical benefit
时间窗: 1 year after procedure
A composite of all-cause death, MI, stent thrombosis, stroke, major bleeding
次要结局
- Each components of net clinical benefit(1 year after procedure)
- Cardiovascular mortality(1 year after procedure)
- Major or minor bleeding(1 year after procedure)
- Major adverse cardiac event(1 year after procedure)