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Effects of Atorvastatin Versus Pravastatin on Platelet Inhibition by Clopidogrel

Primary Purpose

Ischemic Heart Disease, Acute Coronary Syndromes

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
atorvastatin,pravastatin
Sponsored by
Shenyang Northern Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Heart Disease focused on measuring ischemic heart disease, acute coronary syndromes, percutaneous transluminal coronary angioplasty, statin, clopidogrel

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Northern Hospital

Outcomes

Primary Outcome Measures

major adverse cardiac and cerebral events at 1 year

Secondary Outcome Measures

hemorrhage events and subacute thrombosis events at 1 year

Full Information

First Posted
November 28, 2006
Last Updated
November 6, 2008
Sponsor
Shenyang Northern Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00405717
Brief Title
Effects of Atorvastatin Versus Pravastatin on Platelet Inhibition by Clopidogrel
Official Title
Effects of Atorvastatin Versus Pravastatin on Platelet Inhibition by Clopidogrel in Patients With Acute Coronary Syndrome After Percutaneous Coronary Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Shenyang Northern Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease, Acute Coronary Syndromes
Keywords
ischemic heart disease, acute coronary syndromes, percutaneous transluminal coronary angioplasty, statin, clopidogrel

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1300 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
atorvastatin,pravastatin
Primary Outcome Measure Information:
Title
major adverse cardiac and cerebral events at 1 year
Time Frame
1 year
Secondary Outcome Measure Information:
Title
hemorrhage events and subacute thrombosis events at 1 year
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yaling Han, M.D.
Organizational Affiliation
Shenyang Northern Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northern Hospital
City
Shenyang
State/Province
Liaoning
Country
China

12. IPD Sharing Statement

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Effects of Atorvastatin Versus Pravastatin on Platelet Inhibition by Clopidogrel

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