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Effects of Atorvastatin Versus Pravastatin on Platelet Inhibition by Clopidogrel

NCT ID: NCT00405717

Last Updated: 2008-11-07

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

1300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2008-05-31

Brief Summary

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Clopidogrel and statins are frequently coadministered in patients with ischemic heart diseases. Recent reports suggested that clopidogrel's effectiveness in inhibiting adenosine diphosphate (ADP)-induced platelets aggregation is attenuated by co-administration of certain statins. The objective of the present study is to define which kind of statins might interfere with the antiaggregation property of clopidogrel in patients with acute coronary Syndrome after percutaneous coronary intervention (PCI).

In this prospective randomized study, all patients in test group will receive clopidogrel plus atorvastatin, and all patients in control group will receive clopidogrel plus pravastatin. All patients will be followed up for one year. The primary endpoints include death, non fatal AMI, urgent revascularization. The secondary endpoints include hemorrhage events and subacute thrombosis events at 1 year.

Detailed Description

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Conditions

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Ischemic Heart Disease Acute Coronary Syndromes

Keywords

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ischemic heart disease acute coronary syndromes percutaneous transluminal coronary angioplasty statin clopidogrel

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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atorvastatin,pravastatin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with ACS.
* Between ages of 18 Years and 85 years.
* Presence of one or several stenosis in native coronary arteries requiring PCI.
* Willing and able to sign informed consent.

Exclusion Criteria

* A history of bleeding diathesis.
* New York Heart Association functional class IV.
* Prior PCI or coronary bypass grafting \< 3 months.
* Contraindications to statins, clopidogrel and aspirin (White blood cells counts \< 4×109/L or platelet counts \<100 g/l; creatinine clearance \<25 ml/ min; active liver disease).
* Use of glycoprotein IIb/IIIa inhibitors before PCI.
* Use of statins before PCI.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 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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Shenyang Northern Hospital

Principal Investigators

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Yaling Han, M.D.

Role: PRINCIPAL_INVESTIGATOR

Shenyang Northern Hospital

Locations

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Northern Hospital

Shenyang, Liaoning, China

Site Status

Countries

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China

Other Identifiers

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NH-2006-C002

Identifier Type: -

Identifier Source: org_study_id