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

Shenyang Northern Hospital

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease

Treatments: Drug: policosanol plus dual antiplatelet; Drug: high maintenance clopidogrel; Drug: routine dual antiplatelet

Study type: Interventional

Funder types: Other

Identifiers

NCT01371058

NH-20110530

Details and patient eligibility

About

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 .

Full 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

Enrollment: 350 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 3 patient groups

routine dual antiplatelet

Active Comparator group

Description:

asprin 300mg/d for 1 month followed by 100mg/d chronically； clopidogrel 75mg/d for 1year.

Treatment:

Drug: routine dual antiplatelet

high maintenance clopidogrel

Experimental group

Description:

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.

Treatment:

Drug: high maintenance clopidogrel

policosanol plus dual antiplatelet

Experimental group

Description:

asprin 300mg/d for 1 month followed by 100mg/d chronically; clopidogrel 75mg/d for at least 1 year; Policosanol 40mg/d for 6months.

Treatment:

Drug: policosanol plus dual antiplatelet