Study of Tongxinluo to Improve High on Clopidogrel Platelet Reactivity in Patients With Coronary Heart Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 134
- 试验地点
- 3
- 主要终点
- Platelet reaction unit(PRU) measured by verifyNow
研究概览
简要总结
Tongxinluo is a kind of Chinese patent drug,which could promote blood circulation.Recent reports suggested that tongxinluo's effectiveness in reducing the thrombin activity.In this prospective randomized study,all patients in control group will receive blank placebo ,all patients in test group will receive tongxinluo.All patients will be followed up for one year.
详细描述
The primary endpoint is Platelet Reaction Unit( by VerifyNow) at 30 days.The secondary endpoints include inflammation marker (hsCRP、CD62P-CD41),TT,FIB and PT at 30 days,and MI、Ischemic Stroke, target vessel revascularization and all-cause mortality 、bleeding events at 1 year.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1)ACS (including unstable angina pectoris, non-ST-segment elevation myocardial infarction and ST-elevation myocardial infarction) （2）Accept at least one coronary stent. （3）The age between18 and 75 . （4）High on-treatment platelet reactivity defined as an ADP-induced platelet aggregation (by VerifyNow，PRU≥236）at 24 hr after clopidogrel loading (300 ~ 600mg)or 24 hours after PCI.
- •（5）Informed Consent
排除标准
- •（1）Tongxinluo contraindication . （2）Receiving GP IIb / IIIa receptor antagonist treatment （3）Who complicate the known bleeding tendency and blood system diseases. （4）NYHA grade III ~ IV （5）Aspirin or clopidogrel allergies （6）Severe liver or kidney dysfunction （7）Pregnancy （8）Cann't accept 30 days supervision and blood proofer. （9）Other serious illness, life expectancy less than 6 months. （10) Planned surgery recently （11) PCI again within 30 days. (12) Mental diseases interfering understanding the informed consent form （13）Accept other drugs or participate in other clinical research at the same time .
研究组 & 干预措施
Control
Placebo，3 capsules/time，3times/day for 1 year
干预措施: placebo (Drug)
Tongxinluo
Tongxinluo 3 capsules/time 3times/day for 1 year
干预措施: Tongxinluo (Drug)
结局指标
主要结局
Platelet reaction unit(PRU) measured by verifyNow
时间窗: 1 month
to measure the rate of HPR(PRU ≤ 235)
次要结局
- Inflammation Marker (hsCRP、CD62P-CD41)(1 month)
- Plasma fibrinogen concentration(1 month)
- Thrombin time(1 month)
- Prothrombin time(1 month)
- major adverse cardiovascular events(1 year)
- bleeding event(1 year)
- Adverse drug reaction and withdrawal rate(1 month ，1 year)
- Angina recurrence(1 year)
- Traditional Chinese medicine angina symptoms scores(1 year)
- Intra-stent thrombosis(1 year)
研究者
Han Yaling
vice president
Shenyang Northern Hospital