Status:
UNKNOWN
Pravastatin for Acute Myocardial Infarction With Minimally to Mildly Increased Levels of Serum Cholesterol Study
Lead Sponsor:
Osaka Acute Coronary Insufficiency Study Group
Conditions:
Acute Myocardial Infarction
Eligibility:
All Genders
20+ years
Phase:
PHASE4
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 ...
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 hyper...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2011
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00688922
Start Date
July 1 2008
End Date
June 1 2011
Last Update
December 2 2008
Active Locations (9)
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1
Kansai Rosai Hospital
Amagasaki, Hyōgo, Japan
2
Higashi-Osaka City General Hospital
Higashiosaka, Osaka, Japan
3
Kawachi General Hospital
Higashiosaka, Osaka, Japan
4
Osaka Minami Medical Center, National Hospital Organization
Kawachi-Nagano, Osaka, Japan