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

Acute Myocardial Infarction Clinical Trial

— PRACTIC  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00688922
• Other study ID #: PRACTIC080703
• Status: Recruiting
• Phase: Phase 4
• First received: May 29, 2008
• Last updated: November 28, 2008
• Start date: July 2008
• Est. completion date: June 2011

Study information

• Verified date: November 2008
• Source: Osaka Acute Coronary Insufficiency Study Group
• Contact: Yasuhiko Sakata, MD/PhD
• Phone: 81-6-6879-6612
• Email: sakatayk[@]medone.med.osaka-u.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

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.

Locations

Country	Name	City	State
Japan	Kansai Rosai Hospital	Amagasaki	Hyogo
Japan	Higashi-Osaka City General Hospital	Higashi-Osaka	Osaka
Japan	Kawachi General Hospital	Higashi-Osaka	Osaka
Japan	Osaka Minami Medical Center, National Hospital Organization	Kawachinagano	Osaka
Japan	Osaka General Medical Center	Osaka
Japan	Osaka Police Hospital	Osaka
Japan	Sakurabashi Watanabe Hospital	Osaka
Japan	Osaka Rosai Hospital	Sakai	Osaka
Japan	Osaka University Hospital	Suita	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Osaka Acute Coronary Insufficiency Study Group

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Each component of the primary outcome measures.		20, 50 and 80% of the projected number of patients have been enrolled in the study	Yes