Trial | NCT00688922  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    400
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.
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 Started
Jul 31
2008
Primary Completion
Jun 30
2010
Anticipated
Study Completion
Jun 30
2011
Anticipated
Last Update
Dec 02
2008
Estimate

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.

Criteria 

Inclusion Criteria:

the presence of 2 of the following 3 criteria:

a clinical history of central chest oppression, pain, or tightness lasting for ≥30 minutes
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)
an increase in the serum creatine kinase levels to >2 times the normal laboratory value.
the serum level of LDL-C is ≥70 and 130> mg/dl in the first blood examination soon after admission

Exclusion Criteria:

concurrent therapy with any HMG-CoA reductase inhibitor
previous history of the side effects associated with any HMG-CoA reductase inhibitor
life-threatening arrhythmia
severe chronic congestive heart failure
hepatic dysfunction
renal failure
cerebrovascular disease
poor controlled diabetes
pregnancy, lactation
age <20 years
disability of taking medicine or absence of a written informed consent
Patients whom the doctors consider inappropriate by any other reason
No Results Posted