Official Title: “Pravastatin for Acute Myocardial Infarction With Minimally to Mildly Increased Levels of Serum Cholesterol Study That Evaluates the Effects of Pravastatin for Acute Myocardial Infarction With LDL-Cholesterol Levels of 70-129 mg/dl”

The purpose of the Study is to determine whether early treatment with pravastatin can reduce adverse cardiac events in patients with acute myocardial infarction and minimally to mildly elevated serum Low Density Lipoprotein -Cholesterol (LDL-C) levels.

Study Type: Interventional

Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: June 2010

The investigators previously reported the beneficial effect of early use of low-dose pravastatin on major adverse cardiac events in patients with acute myocardial infarction and mild to moderate hypercholesterolemia in the OACIS-LIPID Study. The PRACTIC study is designed as the OACIS-LIPID II trial to determine whether early treatment with pravastatin can reduce adverse cardiac events in patients with acute myocardial infarction and minimally to mildly elevated serum Low Density Lipoprotein -Cholesterol (LDL-C) levels.

Intervention(s) in this Clinical Trial

• Drug: Pravastatin
  • Take an initial dose of pravastatin to start as 10mg/day, which is the recommended initial dose by Health, Labour and Welfare Ministry of Japan, and a diet counseling.

Primary Measures

• The primary outcome measure (endpoints) is the combination of death, non-fetal myocardial infarction, unstable angina, congestive heart failure requiring re-hospitalization, and revascularization for the infarct related artery.
  • Time Frame: 20, 50 and 80% of the projected number of patients have been enrolled in the study
    Safety Issue?: Yes

Secondary Measures

• The secondary endpoints are re-hospitalization due to other cardiac causes (except coronary revascularization anticipated before randomization) and non-fetal stroke.
  • Time Frame: 20, 50 and 80% of the projected number of patients have been enrolled in the study
    Safety Issue?: Yes

Inclusion Criteria:

• 1. the presence of 2 of the following 3 criteria:
• 1. a clinical history of central chest oppression, pain, or tightness lasting for
• ≥30 minutes
• 2. typical electrocardiographic changes (i.e., ST-segment elevation of >0.1 mV in ≥1 limb or 2 precordial leads, ST-segment depression >0.1 mV in ≥2 leads, abnormal Q waves, or T-wave inversion in ≥2 leads)
• 3. an increase in the serum creatine kinase levels to >2 times the normal laboratory value.
• 2. the serum level of LDL-C is ≥70 and 130> mg/dl in the first blood examination soon after admission

Exclusion Criteria:

• 1. concurrent therapy with any HMG-CoA reductase inhibitor
• 2. previous history of the side effects associated with any HMG-CoA reductase inhibitor
• 3. life-threatening arrhythmia
• 4. severe chronic congestive heart failure
• 5. hepatic dysfunction
• 6. renal failure
• 7. cerebrovascular disease
• 8. poor controlled diabetes
• 9. pregnancy, lactation
• 10. age <20 years
• 11. disability of taking medicine or absence of a written informed consent
• 12. Patients whom the doctors consider inappropriate by any other reason

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Osaka Acute Coronary Insufficiency Study Group

Overall Clinical Trial Officials and Contacts

Overall Contact: Yasuhiko Sakata, MD/PhD 81-6-6879-6612 sakatayk@medone.med.osaka-u.ac.jp

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00688922

Study ID Number: PRACTIC080703

ClinicalTrials.gov Identifier: NCT00688922

Health Authority: Japan: Ministry of Health, Labor and Welfare