TRIAGE: Patients Undergoing Percutaneous Coronary Interventions to Improve Clinical Outcomes Through Optimal Platelet Inhibition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 318
- 试验地点
- 1
- 主要终点
- MACE
研究概览
简要总结
The purpose of this study is to assess the the 1-year rates of ischemic and bleeding complications in patients whose dual antiplatelet therapy regimen post-PCI has been determined with the use of a clinical algorithm that includes both clinical risks and platelet reactivity while on chronic clopidogrel therapy.
详细描述
Prospective multicenter registry. Patients already on chronic dual antiplatelet therapy with aspirin and clopidogrel will be assessed for (1) clinical risks factors for future bleeding and ischemic complications, and (2) on-treatment platelet reactivity as measured by the VerifyNow P2Y12 assay (Accumetrics, Inc., San Diego, CA, USA). These will be considered by utilization of a clinical algorithm to determine the dual antiplatelet regimen post-PCI (aspirin in combination with 1. clopidogrel, 2. prasugrel 5mg daily, or 3. prasugrel 10mg daily).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject has provided informed written.
- •The subject must be ≥ 18 years of age (or minimum age as required by local regulations) at the time of enrollment.
- •Patient is established on chronic clopidogrel therapy when he/she returns for PCI, and the components of DAPT are determined by the clinical decision algorithm as local standard of care.
- •The subject is willing and able to cooperate with the study procedures and required follow-ups.
排除标准
- •Patients with cardiogenic shock will be excluded.
- •The subject is participating in an investigational device or drug study. Subject must have completed the follow up phase of any previous study at least 30 days prior to enrolment in this study.
- •Pregnant women.
结局指标
主要结局
MACE
时间窗: 12 months
Major adverse cardiac events (all-cause death, myocardial infarction and stent thrombosis)
次要结局
- Rates of major bleeding(12 months)