Investigator Initiated Prospective Study to Investigate the Best Anti-platelet Treatment in High Thrombotic Risk PCI Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,078
- 试验地点
- 1
- 主要终点
- Major adverse cardiac and cerebrovascular events
研究概览
简要总结
To identify the high-risk patients who might have in-stent thrombosis after PCI with thromboelastography and to head-to-head compare two intensified antiplatelet therapeutic strategies of double-dosage Clopidogrel and triple antiplatelet therapy with Cilostazol with the standard antiplatelet therapy.
详细描述
Study population: Age 18 - 75, male or non-pregnant female; stable or unstable angina with evidence of myocardial ischemia, or patient with myocardial infarction; coronary angiography reveals stenosis lesions; discovery of ADP induced platelet inhibition rate < 50% and MAADP > 47mm via thromboelastography (indicating low responsiveness to Clopidogrel with high risk for stent thrombosis formation); is able to understand the objective of the trial, takes part voluntarily and signs the written informed consent form.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 75, male or non-pregnant female;
- •Stable or unstable angina with evidence of myocardial ischemia, or patient with myocardial infarction;
- •Coronary angiography reveals stenosis lesions;
- •Discovery of ADP induced platelet inhibition rate < 50% and MAADP >47mm via thromboelastography (indicating low responsiveness to Clopidogrel with high risk for stent thrombosis formation);
- •Is able to understand the objective of the trial, takes part voluntarily and signs the written informed consent form.
排除标准
- •Those who have participated in other drug or therapy equipment clinical trials but did not reach the main study endpoint time limit;
- •Symptoms of severe heart failure (NYHA Class III and above) or left ventricular ejection fraction < 40% (ultrasound or left ventricle ngiography);
- •Pregnant or lactating women;
- •severely impaired renal function before surgery: serum creatinine > 2.0mg/dl;
- •Impaired liver function before surgery: Serum GPT > 120U/L;
- •Bleeding tendency, history of active peptic ulcer, history of cerebral hemorrhage or cavum subarachnoidale bleeding, patients with antiplatelet agent and anticoagulant treatment contraindications and hence are unable to undergo anticoagulant therapy;
- •Patients who are unable to withstand dual antiplatelet therapy due to allergy to Aspirin, Clopidogrel or ticlopidine, heparin, contrast agent, paclitaxel and metals;
- •Leucocyte < 3.5 x 109; and/or platelet < 100,000/mm3 or > 750,000/mm3;
- •Patient's life expectancy is less than 12 months;
- •Patients who plan to undergo coronary artery bypass grafting or other surgery within 1 year;
- •Those waiting for heart transplant;
- •Patients who are deemed by the researchers to have low compliance and unable to abide by the requirements and complete the study.
研究组 & 干预措施
Clopidogrel + Aspirit
A Standard antiplatelet therapy control group： Clopidogrel 75mg Qd + Aspirin 100mg Qd
干预措施: Clopidogrel 75mg (Drug)
Clopidogrel + Aspirit
A Standard antiplatelet therapy control group： Clopidogrel 75mg Qd + Aspirin 100mg Qd
干预措施: Aspirin 100mg (Drug)
Clopidogrel + Aspirin
B Double-dosage Clopidogrel group： Clopidogrel 150mg Qd + Aspirin 100mg Qd
干预措施: Clopidogrel 150mg (Drug)
Clopidogrel + Aspirin
B Double-dosage Clopidogrel group： Clopidogrel 150mg Qd + Aspirin 100mg Qd
干预措施: Aspirin 100mg (Drug)
Clopidogrel + Aspirin + Cilostazol
C triple antiplatelet therapy group： Cilostazol 100mg Bid + Aspirin 100mg Qd + Clopidogrel 75mg Qd
干预措施: Clopidogrel 75mg (Drug)
Clopidogrel + Aspirin + Cilostazol
C triple antiplatelet therapy group： Cilostazol 100mg Bid + Aspirin 100mg Qd + Clopidogrel 75mg Qd
干预措施: Aspirin 100mg (Drug)
Clopidogrel + Aspirin + Cilostazol
C triple antiplatelet therapy group： Cilostazol 100mg Bid + Aspirin 100mg Qd + Clopidogrel 75mg Qd
干预措施: Cilostazol 100mg (Drug)
结局指标
主要结局
Major adverse cardiac and cerebrovascular events
时间窗: within 1.5years of patient enrolled
MACCE, including cardiac death, myocardial infarction, target vessel revascularization and cerebrovascular events
次要结局
- Secondary endpoint(within 1.5 years of patients enrolled)
- bleeding(within 1.5 years of patients' enrolled)
- quality of life of patient(within 1.5 years of patients' enrolled)
研究者
Yi-Da Tang
Professor
Chinese Academy of Medical Sciences, Fuwai Hospital