Clinical trial NCT01371058: Study of Policosanol to Improve Platelet Reactivity After Percutaneous Coronary Stent Implantation (PCI)
Official title: Study of Policosanol to Improve High on Clopidogrel Platelet Reactivity After Percutaneous Coronary Stent Implantation(Spirit)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: high on-treatment platelet reactivity
percutaneous coronary intervention
stent thrombosis
Lead sponsor: Shenyang Northern Hospital
Sponsor class: OTHER
First posted: 2011-06-10
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: reversion rate of HPR
timeFrame: 30 days
Secondary outcomes:
measure: major adverse cardiovascular events
timeFrame: 1 year
measure: Stent thrombosis and TIMI bleeding events
timeFrame: 1 year
Other outcomes:
Locations:
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
Study officials:
affiliation: Shenyang Northern Hospital
name: Yaling Han, MD
role: PRINCIPAL_INVESTIGATOR
References: