Acute Myocardial Infarction
Conditions
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.
Interventions
DRUGPravastatin
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.
Sponsors
Osaka Acute Coronary Insufficiency Study Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Each component of the primary outcome measures. | 20, 50 and 80% of the projected number of patients have been enrolled in the study |
Countries
Japan
Contacts
Primary ContactYasuhiko Sakata, MD/PhD
Outcome results
None listed