Study of Policosanol to Improve Platelet Reactivity After Percutaneous Coronary Stent Implantation (PCI)
- Conditions
- Coronary Artery Disease
- Interventions
- Drug: routine dual antiplatelet
- Registration Number
- NCT01371058
- Lead Sponsor
- Shenyang Northern Hospital
- Brief Summary
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 .
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 350
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description routine dual antiplatelet routine dual antiplatelet asprin 300mg/d for 1 month followed by 100mg/d chronically； clopidogrel 75mg/d for 1year. policosanol plus dual antiplatelet 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. high maintenance clopidogrel 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.
- Primary Outcome Measures
Name Time Method reversion rate of HPR 30 days reversion was defined as platelet aggregation \<65%
- Secondary Outcome Measures
Name Time Method major adverse cardiovascular events 1 year including cardiac death, non-fatal myocardial infarction and target vessel revascularization
Stent thrombosis and TIMI bleeding events 1 year
Trial Locations
- Locations (1)
The First Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China