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Effects of Atorvastatin Versus Pravastatin on Platelet Inhibition by Clopidogrel

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00405717
Recruitment Status : Completed
First Posted : November 30, 2006
Last Update Posted : November 7, 2008
Sponsor:
Information provided by:
Shenyang Northern Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Ischemic Heart Disease Acute Coronary Syndromes Drug: atorvastatin,pravastatin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Atorvastatin Versus Pravastatin on Platelet Inhibition by Clopidogrel in Patients With Acute Coronary Syndrome After Percutaneous Coronary Intervention
Study Start Date : February 2006
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. major adverse cardiac and cerebral events at 1 year [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. hemorrhage events and subacute thrombosis events at 1 year [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00405717


Locations
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China, Liaoning
Northern Hospital
Shenyang, Liaoning, China
Sponsors and Collaborators
Shenyang Northern Hospital
Investigators
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Principal Investigator: Yaling Han, M.D. Shenyang Northern Hospital
More Information
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Responsible Party: Yaling Han, Shenyang Northern Hospital
ClinicalTrials.gov Identifier: NCT00405717    
Other Study ID Numbers: NH-2006-C002
First Posted: November 30, 2006    Key Record Dates
Last Update Posted: November 7, 2008
Last Verified: November 2008
Keywords provided by Shenyang Northern Hospital:
ischemic heart disease
acute coronary syndromes
percutaneous transluminal coronary angioplasty
statin
clopidogrel
Additional relevant MeSH terms:
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Heart Diseases
Acute Coronary Syndrome
Myocardial Ischemia
Coronary Artery Disease
Syndrome
Disease
Pathologic Processes
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
 Arterial Occlusive Diseases
Atorvastatin
Pravastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors