Clinical trial NCT00688922: Pravastatin for Acute Myocardial Infarction With Minimally to Mildly Increased Levels of Serum Cholesterol Study
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Myocardial Infarction
Lead sponsor: Osaka Acute Coronary Insufficiency Study Group
Sponsor class: OTHER
First posted: 2008-06-03
Enrollment: 400
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 20, 50 and 80% of the projected number of patients have been enrolled in the study
Secondary outcomes:
measure: Each component of the primary outcome measures.
timeFrame: 20, 50 and 80% of the projected number of patients have been enrolled in the study
Other outcomes:
Locations:
city: Amagasaki
country: Japan
facility: Kansai Rosai Hospital
state: Hyogo
city: Higashi-Osaka
country: Japan
facility: Higashi-Osaka City General Hospital
state: Osaka
city: Higashi-Osaka
country: Japan
facility: Kawachi General Hospital
state: Osaka
city: Kawachinagano
country: Japan
facility: Osaka Minami Medical Center, National Hospital Organization
state: Osaka
city: Sakai
country: Japan
facility: Osaka Rosai Hospital
state: Osaka
city: Suita
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Osaka
country: Japan
facility: Osaka General Medical Center
city: Osaka
country: Japan
facility: Osaka Police Hospital
city: Osaka
country: Japan
facility: Sakurabashi Watanabe Hospital
Study officials:
References: