Myocardial Infarction
Conditions
Keywords
randomized prospective study, lipid-lowering therapy with any available statins, multicenter study, Japanese, acute myocardial infarction, primary percutaneous coronary intervention
Brief summary
Statins have been shown to prevent coronary artery disease and to preserve left ventricular function in dilated cardiomyopathy. The investigators hypothesized that the early use of statins would reduce cardiovascular events including heart failure in acute myocardial infarction patients. The purpose of this study is to determine whether early (within 96 hours after onset) use of any available statins are effective to prevent cardiovascular events including heart failure after acute myocardial infarction in Japanese patients.
Detailed description
At least, in Japanese, it was controversial if lipid-lowering therapy to the patients whose total cholesterol levels \<240 mg/dL was needed. Furthermore, in general, a role for early statin therapy in patients with ST-elevated AMI reperfused by primary PCI has not been clearly established. Statins have been shown to prevent coronary artery disease and to preserve left ventricular function in dilated cardiomyopathy. The investigators hypothesized that the early use of statins would reduce cardiovascular events including heart failure in acute myocardial infarction patients. A prospective, randomized, open-label, multicenter trial is conducted in AMI patients with normal total cholesterol levels (180-240 mg/dL). Patients are randomly assigned to receive any available statin within 96 hours of AMI onset or no statin and were followed for up to 24 months. The primary endpoint is a composite of cardiovascular death, nonfatal AMI, recurrent symptomatic myocardial ischemia, congestive heart failure, and stroke.
Interventions
DRUGlipid-lowering treatment
Sponsors
Kumamoto University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of acute myocardial infarction * Serum total cholesterol levels on admission ranges ≥180 mg/dL and \<240 mg/dL
Exclusion criteria
* Age \< 18 years * Time from symptom onset to admission \> 96 hours * Use of lipid-lowering agents within the previous 3 months * Known familial dyslipidemia * Severe renal failure * Known hepatic disease * Signs and symptoms of severe heart failure (Killip class III or IV) * A scheduled PCI or coronary artery bypass grafting (CABG) * A history of previous PCI (within 6 months) or CABG (within 3 months) * The presence of malignant disease * The presence of allergy to statins.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| and nonfatal stroke | — |
| nonfatal acute myocardial infarction | — |
| recurrent symptomatic myocardial ischemia with objective evidence and requiring emergency rehospitalization | — |
| congestive heart failure requiring emergent rehospitalization | — |
| A combination of: cardiovascular death | — |
Secondary
| Measure | Time frame |
|---|---|
| percutaneous coronary intervention (PCI) for a new lesion | — |
| and repeat PCI procedures for restenosis of the infarct-related or non-infarct-related lesions (repeat PCI occurring in the first 6 months of follow-up for an index lesion was excluded) | — |
| Reintervention procedures: coronary artery bypass grafting (CABG) | — |
Countries
Japan
Outcome results
None listed