Comparison of Clopidogrel and Ticagrelor on Microvascular Dysfunction in Acute Coronary Syndrome Patients: The Index of MIcrocirculatory Resistance After PCI in STEMI Patients (TIME Study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Index of microcirculatory resistance (IMR) measured after successful coronary intervention
研究概览
简要总结
Ticagrelor is a non-thienophyridine, direct P2Y12 blocker that is more potent than clopidogrel and is associated with less interindividual variability. In the PLATO trial, it was found to be superior to clopidogrel with respect to cardiovascular outcomes and total mortality without increasing the risk of bleedings.
More potent and reversible receptor bindings are possible explanation for the superior outcomes. Beside the potent effect on inhibition of antiplatelet function, ticagrelor has previously been demonstrated to increase adenosine levels by inhibiting adenosine re-uptake in tissue level and can induce adenosine triphosphate (ATP) release from human red cells, which both stimulate vasodilation of in red blood cells.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and Females
- •between the ages of 18 and 75 years
- •STEMI patients treated with percutaneous coronary intervention
- •Able to provide informed consent
排除标准
- •History of stroke or transient ischemic attack
- •Platelet count < 100 000/μL
- •Known Bleeding Diathesis
- •Hematocrit <30% or >52%
- •Severe Liver Dysfunction
- •Renal Insufficiency (Creatinine Clearance < 30ml/min)
- •Pregnant females
- •Cardiogenic shock or symptomatic hypotension or sitting SBP < 95 mmHg
研究组 & 干预措施
Clopidogrel
Clopidogrel 600mg loading
干预措施: Clopidogrel (Drug)
Ticagrelor
Ticagrelor 180mg loading
干预措施: Ticagrelor (Drug)
结局指标
主要结局
Index of microcirculatory resistance (IMR) measured after successful coronary intervention
时间窗: IMR will be immediately assessed after successful PCI patients within 48hr from admission
次要结局
- wall motion score index on three month later TTE from index PCI(TTE will be assessed in all enrolled patients 3 month later from index PCI)