Effects of Atorvastatin Versus Pravastatin on Platelet Inhibition by Clopidogrel

Ischemic Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00405717
• Other study ID #: NH-2006-C002
• Status: Completed
• Phase: Phase 4
• First received: November 28, 2006
• Last updated: November 6, 2008
• Start date: February 2006
• Est. completion date: May 2008

Study information

• Verified date: November 2008
• Source: Shenyang Northern Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1300
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndromes
• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Drug:
• atorvastatin,pravastatin

Locations

Country	Name	City	State
China	Northern Hospital	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Shenyang Northern Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	major adverse cardiac and cerebral events at 1 year		1 year	No
Secondary	hemorrhage events and subacute thrombosis events at 1 year		1 year	Yes