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Effects of Atorvastatin Versus Pravastatin on Platelet Inhibition by Clopidogrel

This study has been completed.
Sponsor:
Information provided by:
Shenyang Northern Hospital
ClinicalTrials.gov Identifier:
NCT00405717
First received: November 28, 2006
Last updated: November 6, 2008
Last verified: November 2008
History of Changes
  Purpose

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 Intervention Phase
Ischemic Heart Disease
Acute Coronary Syndromes
 Drug: atorvastatin,pravastatin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shenyang Northern Hospital:

Primary Outcome Measures:
  • major adverse cardiac and cerebral events at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • hemorrhage events and subacute thrombosis events at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1300
Study Start Date: February 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00405717

Locations
China, Liaoning
Northern Hospital
Shenyang, Liaoning, China
Sponsors and Collaborators
Shenyang Northern Hospital
Investigators
Principal Investigator: Yaling Han, M.D. Shenyang Northern Hospital
  More Information

No publications provided

Responsible Party: Yaling Han, Shenyang Northern Hospital
ClinicalTrials.gov Identifier: NCT00405717     History of Changes
Other Study ID Numbers: NH-2006-C002
Study First Received: November 28, 2006
Last Updated: November 6, 2008
Health Authority: China: Ministry of Health

Keywords provided by Shenyang Northern Hospital:
ischemic heart disease
acute coronary syndromes
percutaneous transluminal coronary angioplasty
statin
clopidogrel

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Ischemia
Acute Coronary Syndrome
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms
 Clopidogrel
Atorvastatin
Pravastatin
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hydroxymethylglutaryl-CoA Reductase Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013