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Completed

NCT Number: NCT00405717

Effects of Atorvastatin Versus Pravastatin on Platelet Inhibition by Clopidogrel

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.

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Key information

Conditions

Ischemic Heart Disease Acute Coronary Syndrome Acute Coronary Syndromes Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Northern Hospital

Shenyang, Liaoning, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

atorvastatin,pravastatin

Drug

Primary outcomes

  1. major adverse cardiac and cerebral events at 1 year

    Time frame: 1 year

Secondary outcomes

  1. hemorrhage events and subacute thrombosis events at 1 year

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Shenyang Northern Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Nov 30, 2006
Registry last updated
Nov 7, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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