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Effects of Atorvastatin Versus Pravastatin on Platelet Inhibition by Clopidogrel

Effects of Atorvastatin Versus Pravastatin on Platelet Inhibition by Clopidogrel in Patients With Acute Coronary Syndrome After Percutaneous Coronary Intervention

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00405717
Enrollment
1300
Registered
2006-11-30
Start date
2006-02-28
Completion date
2008-05-31
Last updated
2008-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndromes, Ischemic Heart Disease

Keywords

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

Brief summary

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.

Interventions

DRUGatorvastatin,pravastatin

Sponsors

Shenyang Northern Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
major adverse cardiac and cerebral events at 1 year1 year

Secondary

MeasureTime frame
hemorrhage events and subacute thrombosis events at 1 year1 year

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026