The Use of Statins for Myocardial Death Prevention

Rambam Health Care Campus

Status and phase: Completed; Phase 4

Conditions: Myocardial Infarction

Treatments: Drug: Atorvastatin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00772564

Ator2685Hdm2[2]

Details and patient eligibility

About

The administration of high dose HMG-CoA reductase inhibitors (Statins) to patients with acute ST-elevation MI (hypoxia/ischemia) who are treated with primary PCI (reoxygenation/ reperfusion) will protect their cardiomyocytes from death and thus preserve LV ejection fraction.

Enrollment: 25 patients

Sex: All

Ages: 30 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients suffering from acute ST elevation resulting from myocardial infarction, Killip Classification 1 and 2 will be included at-random to either group. Included subjects should be able to give their informed consent to participate in this study.

Exclusion criteria

1. The impossibility to give the required informed consent.
2. Known allergy to Atorvastatin.
3. Base line serum creatinine of 1.4 mg/dL.
4. Killip Classification 3 and 4.
5. Persisting vomiting.
6. History of previous liver disease.
7. History of previous muscle disease or rabdomyolisis.
8. Treated already with high dose atorvastatin
9. Non Compliance.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Atorvastatin 80 mg

Experimental group

Treatment:

Drug: Atorvastatin

Atorvastatin 10 mg

Experimental group

Treatment:

Drug: Atorvastatin