Ticagrelor Monotherapy After 3 Months in the Patients Treated With New Generation Sirolimus Stent for Acute Coronary Syndrome (TICO Study)
试验速览
- 阶段
- 4 期
- 入组人数
- 3,056
- 试验地点
- 1
- 主要终点
- Major adverse cardiovascular clinical events (MACCE)
研究概览
简要总结
To compare the clinical outcomes of dual antiplatelet therapy with aspirin and ticagrelor vs. ticagrelor monotherapy at 3 months after PCI in patients with acute coronary syndrome.
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 79 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 (Osiro®) stent implantation for treating ACS
- •Patients without significant clinical events such as MI, stent thrombosis or revascularization until 3 months after PCI
- •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
- •Patients who treated with strong CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir, or atazanavir)
- •Patients who had history of intracranial hemorrhage
- •Moderate to severe hepatic dysfunction
- •Increased risk of bradycardia-related symptom (Guidance and reference)
研究组 & 干预措施
Ticagrelor monotherapy
Ticagrelor monotherapy at 3 months after PCI
干预措施: Ticagrelor monotherapy (Drug)
Ticagrelor with Aspirin
Ticagrelor with Aspirin DAPT(Dual Anti-platelet Treatment)
干预措施: Ticagrelor with Aspirin DAPT(dual antiplatelet treatment) (Drug)
结局指标
主要结局
Major adverse cardiovascular clinical events (MACCE)
时间窗: 1 year after the procedure
major bleeding
时间窗: 1 year after the procedure
Major bleeding means 1) any intracranial bleeding (excluding microhemorrhages \<10 mm evident only on gradient-echo MRI), 2) clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥5 g/dL or a ≥15% absolute decrease in haematocrit, and 3) fatal bleeding (bleeding that directly results in death within 7 days) in accordance with TIMI Bleeding Criteria.
次要结局
未报告次要终点