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

NCT ID: NCT01371058

Last Updated: 2015-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-09-30

Brief Summary

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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

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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

Conditions

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Coronary Artery Disease

Keywords

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high on-treatment platelet reactivity percutaneous coronary intervention stent thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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routine dual antiplatelet

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

Group Type ACTIVE_COMPARATOR

routine dual antiplatelet

Intervention Type DRUG

clopidogel 75mg/d for at least 1 year； aspirin 300mg/d for 1 month followed by 100mg/d chronically；

high maintenance clopidogrel

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.

Group Type EXPERIMENTAL

high maintenance clopidogrel

Intervention Type DRUG

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；

policosanol plus dual antiplatelet

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

Group Type EXPERIMENTAL

policosanol plus dual antiplatelet

Intervention Type DRUG

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

Interventions

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high 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；

Intervention Type DRUG

routine dual antiplatelet

clopidogel 75mg/d for at least 1 year； aspirin 300mg/d for 1 month followed by 100mg/d chronically；

Intervention Type DRUG

policosanol 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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shenyang Northern Hospital

OTHER

Sponsor Role lead

Responsible Party

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Han Yaling

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yaling Han, MD

Role: PRINCIPAL_INVESTIGATOR

Shenyang Northern Hospital

Locations

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The First Hospital of China Medical University

Shenyang, Liaoning, China

Site Status

Countries

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China

Other Identifiers

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NH-20110530

Identifier Type: -

Identifier Source: org_study_id