Study of Policosanol to Improve High on Clopidogrel Platelet Reactivity After Percutaneous Coronary Stent Implantation(Spirit)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- reversion rate of HPR
研究概览
简要总结
Thrombotic event is one of the most serious complications of coronary artery disease, which often result in myocardial infarction and even death. Even according to the standard guidelines for antiplatelet therapy, there are still 6% to 15% of patients occur thrombotic events, in high-risk patients, the proportion is higher, this phenomenon is called anti-platelet drug resistance in clinical practice
The aim of this multicenter prospective, randomized, controlled study is to observed policosanol on aspirin or clopidogrel resistance in patients with platelet aggregation after Percutaneous Coronary Stent Implantation (PCI) and occurrence of platelet aggregation and short-term prognosis to find new ways to the prevention of platelet aggregation .
详细描述
Thrombotic event is one of the most serious complications in coronary artery disease, which often result in myocardial infarction and even death. Even according to the standard guidelines for antiplatelet therapy, there are still 6% to 15% of patients occur thrombotic events, in high-risk patients, the proportion is higher, this phenomenon is called anti-platelet drug resistance in clinical practice
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patients with coronary heart disease and had received coronary stenting
- •high on-treatment platelet reactivity defined as an ADP-induced platelet aggregation (by LTA)> 65% at 24 hr after clopidogrel loading (300 ~ 600mg)or 5 days after maintenance dose treatment (75mg / d)
- •Informed Consent
排除标准
- •receiving GP IIb / IIIa receptor antagonist treatment within 24h before enrollment
- •using cilostazol within 7d before enrollment
- •aspirin, clopidogrel or policosanol allergies
- •NYHA grade III ~ IV
- •planned elective coronary revascularization for multivessel coronary artery disease
- •long term warfarin treatment after persistent atrial fibrillation, valve surgery or other circumstance
- •Severe liver or kidney dysfunction
- •Active ulcer or a history of recent gastrointestinal bleeding
- •History of coagulation disorder, or recent history of active bleeding
- •history of intracranial hemorrhage within 6 months
- •Pregnancy
- •LDL less than 70mg/dL
- •Severe systemic diseases with life expectancy less than 1 year
- •planned surgery within next 6 months
研究组 & 干预措施
routine dual antiplatelet
asprin 300mg/d for 1 month followed by 100mg/d chronically； clopidogrel 75mg/d for 1year.
干预措施: routine dual antiplatelet (Drug)
high maintenance clopidogrel
aspirin 300mg/d for 1 month followed by 100mg/d chronically; clopidogrel 150mg/d for 1 month followed by 75mg/d for at least 1 year.
干预措施: high maintenance clopidogrel (Drug)
policosanol plus dual antiplatelet
asprin 300mg/d for 1 month followed by 100mg/d chronically; clopidogrel 75mg/d for at least 1 year; Policosanol 40mg/d for 6months.
干预措施: policosanol plus dual antiplatelet (Drug)
结局指标
主要结局
reversion rate of HPR
时间窗: 30 days
reversion was defined as platelet aggregation \<65%
次要结局
- major adverse cardiovascular events(1 year)
- Stent thrombosis and TIMI bleeding events(1 year)
研究者
Han Yaling
Dr
Shenyang Northern Hospital