Effects of Atorvastatin Versus Pravastatin on Platelet Inhibition by Clopidogrel
Information source: Shenyang Northern Hospital
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ischemic Heart Disease; Acute Coronary Syndromes
Intervention: atorvastatin,pravastatin (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Shenyang Northern Hospital Official(s) and/or principal investigator(s):
Yaling Han, M.D., Principal Investigator, Affiliation: Shenyang Northern Hospital
Overall contact:
Yi Li, M.D., Phone: 86-24-2305-1587, Email: doctorliyi@126.com
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.
Clinical Details
Official title: Effects of Atorvastatin Versus Pravastatin on Platelet Inhibition by Clopidogrel in Patients With Acute Coronary Syndrome After Percutaneous Coronary Intervention
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: major adverse cardiac and cerebral events at 1 year
Secondary outcome: hemorrhage events and subacute thrombosis events at 1 year
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Yi Li, M.D., Phone: 86-24-2305-1587, Email: doctorliyi@126.com
Northern Hospital, shenyang, Liaoning, China; Recruiting
LIYi , M.D., Phone: 86-24-2305-1587
Additional Information
Starting date: February 2006
Ending date: April 2008
Last updated: November 29, 2006
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