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

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

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 .

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shenyang Northern Hospital
• Treatments: Aspirin; Clopidogrel; Policosanol; Ticlopidine

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