Study of Policosanol to Improve Platelet Reactivity After Percutaneous Coronary Stent Implantation (PCI)

Study Overview
=================
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

Official Title
-----------------
Study of Policosanol to Improve High on Clopidogrel Platelet Reactivity After Percutaneous Coronary Stent Implantation(Spirit)

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Drug: high maintenance clopidogrel
* Drug: routine dual antiplatelet
* Drug: policosanol plus dual antiplatelet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: routine dual antiplatelet<br>asprin 300mg/d for 1 month followed by 100mg/d chronically； clopidogrel 75mg/d for 1year. | Drug: routine dual antiplatelet<br>* clopidogel 75mg/d for at least 1 year； aspirin 300mg/d for 1 month followed by 100mg/d chronically；<br>|
| Experimental: high maintenance clopidogrel<br>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. | Drug: high maintenance clopidogrel<br>* clopidogrel 150 mg/d for 30 days followed by 75 mg/d for at least 1 year； aspirin 300mg/d for 1 month followed by 100mg/d chronically；<br>|
| Experimental: policosanol plus dual antiplatelet<br>asprin 300mg/d for 1 month followed by 100mg/d chronically; clopidogrel 75mg/d for at least 1 year; Policosanol 40mg/d for 6months. | Drug: policosanol plus dual antiplatelet<br>* aspirin 300 mg/d for 1 month followed by 100 mg/d chronically； clopidogrel 75 mg/d for at least 1 year policosanol 40mg/d for 6 months<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reversion rate of HPR | reversion was defined as platelet aggregation <65% | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major adverse cardiovascular events | including cardiac death, non-fatal myocardial infarction and target vessel revascularization | 1 year | 
| Stent thrombosis and TIMI bleeding events |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
high on-treatment platelet reactivity, percutaneous coronary intervention, stent thrombosis