Antiplatelet Therapy Guided by Thrombelastography in Patients With Acute Coronary Syndromes (TEGCOR Study)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Thrombelastography (TEG) MA
研究概览
简要总结
Personalized treatment approaches and antiplatelet drug choice have been proposed to optimize safety of coronary stenting by reducing heart attacks and repeat interventions while simultaneously minimizing adverse bleeding events. This study compares the efficacy of two laboratory guided treatment algorithms to personalize antiplatelet medication choice after coronary stenting
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
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted with acute coronary syndrome (unstable angina, non-ST elevation myocardial infarction) and referred for coronary angiography.
- •Current therapy with clopidogrel (at least 300mg loading dose, or 75mg po daily for >5 days)
- •Age range 21-75 years.
排除标准
- •Unable to give consent
- •Age younger than 21 years, greater than 75 years
- •History of stroke
- •Body weight <60 kg
- •Acute STEMI,
- •Thrombocytopenia<100'000,
- •requirement for chronic warfarin therapy
研究组 & 干预措施
TEG
Clopidogrel non-response defined as MA≥69 Clopidogrel response defined as MA<69
干预措施: Prasugrel (Drug)
TEG
Clopidogrel non-response defined as MA≥69 Clopidogrel response defined as MA<69
干预措施: Clopidogrel (Drug)
Light transmittance aggregometry
Clopidogrel non-response defined as MPA ADP >42.9% Clopidogrel response defined as MPA ADP <42.9%
干预措施: Prasugrel (Drug)
Light transmittance aggregometry
Clopidogrel non-response defined as MPA ADP >42.9% Clopidogrel response defined as MPA ADP <42.9%
干预措施: Clopidogrel (Drug)
结局指标
主要结局
Thrombelastography (TEG) MA
时间窗: 1 day
Persistence of high tensile clot strength measured by TEG 16-24 hours after reloading of either clopidogrel or prasugrel
次要结局
- Number of Participants With Ischemic Events(6 months)
- Number of Participants With Bleeding Events(6 months)
研究者
Rolf Kreutz
M.D., Associate Professor of Clinical Medicine
Indiana University