Effects of Atorvastatin Versus Pravastatin on Platelet Inhibition by Clopidogrel

NCT00405717 | Completed Phase 4

• 1 other identifier: NH-2006-C002
• Study Type: interventional
• Target: 1,300
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Heart Disease; Acute Coronary Syndromes

Keywords

ischemic heart disease; acute coronary syndromes; percutaneous transluminal coronary angioplasty; statin; clopidogrel

Outcome Measures

Primary Outcomes (1)

• major adverse cardiac and cerebral events at 1 year

  1 year

Secondary Outcomes (1)

• hemorrhage events and subacute thrombosis events at 1 year

  1 year

Interventions

atorvastatin,pravastatin DRUG

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenyang Northern Hospital: lead

Study Sites (1)

Northern Hospital

Shenyang, Liaoning, China

Location

MeSH Terms

Conditions

Myocardial Ischemia; Acute Coronary Syndrome

Interventions

Atorvastatin; Pravastatin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Yaling Han, M.D.

  Shenyang Northern Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 28, 2006
• First Posted: November 30, 2006
• Study Start: February 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: November 7, 2008

Record last verified: 2008-11

Locations

CN (1)