Overview

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

Status:
Unknown status
Trial end date:
2011-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Osaka Acute Coronary Insufficiency Study Group
Treatments:
Pravastatin
Criteria
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