Coronary Artery Disease
Conditions
Keywords
high on-treatment platelet reactivity, percutaneous coronary intervention, stent thrombosis
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
Interventions
DRUGhigh maintenance clopidogrel
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；
DRUGroutine dual antiplatelet
clopidogel 75mg/d for at least 1 year； aspirin 300mg/d for 1 month followed by 100mg/d chronically；
DRUGpolicosanol plus dual antiplatelet
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
Sponsors
Shenyang Northern Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| reversion rate of HPR | 30 days | reversion was defined as platelet aggregation \<65% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
China
Outcome results
None listed