Pravastatin for Acute Myocardial Infarction With Minimally to Mildly Increased Levels of Serum Cholesterol Study

Phase 4

• Conditions: Acute Myocardial Infarction

• Registration Number: NCT00688922
• Lead Sponsor: Osaka Acute Coronary Insufficiency Study Group

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2008-05-29
• Study First Submitted QC: 2008-06-02
• Study First Posted: 2008-06-03
• Study Start: 2008-07
• Status Verified: 2008-11
• Last Update Submitted: 2008-11-28
• Last Update Posted: 2008-12-02
• Primary Completion: 2010-06
• Study Completion: 2011-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Combination of death, non-fatal myocardial infarction, unstable angina, coronary revascularization (except anticipated revascularization before randomization), non-fatal stroke and re-hospitalization due to heart failure or other cardiac causes.	20, 50 and 80% of the projected number of patients have been enrolled in the study

Secondary Outcome Measures

Name	Time	Method
Each component of the primary outcome measures.	20, 50 and 80% of the projected number of patients have been enrolled in the study

Trial Locations

Locations (9)

Higashi-Osaka City General Hospital; 🇯🇵 Higashi-Osaka, Osaka, Japan

Kawachi General Hospital; 🇯🇵 Higashi-Osaka, Osaka, Japan

Kansai Rosai Hospital; 🇯🇵 Amagasaki, Hyogo, Japan

Osaka Rosai Hospital; 🇯🇵 Sakai, Osaka, Japan

Osaka University Hospital; 🇯🇵 Suita, Osaka, Japan

Sakurabashi Watanabe Hospital; 🇯🇵 Osaka, Japan

Osaka Police Hospital; 🇯🇵 Osaka, Japan

Osaka General Medical Center; 🇯🇵 Osaka, Japan

Osaka Minami Medical Center, National Hospital Organization; 🇯🇵 Kawachinagano, Osaka, Japan