The Use of Statins for Myocardial Death Prevention
This study has been completed.
Information provided by (Responsible Party):
N_Krivoy, Rambam Health Care Campus
First received: October 11, 2008
Last updated: May 25, 2012
Last verified: May 2012
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
||The Use of Statins for Myocardial Death Prevention: From Cell to Bedside
Primary Outcome Measures:
- Heart EcoCardiography and specific laboratory tests [ Time Frame: Base line, second day and 60 days after myocardial infarction ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2010 (Final data collection date for primary outcome measure)
Experimental: Atorvastatin 80 mg
Experimental: Atorvastatin 10 mg
|Ages Eligible for Study:
||30 Years to 90 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- The impossibility to give the required informed consent.
- Known allergy to Atorvastatin.
- Base line serum creatinine of 1.4 mg/dL.
- Killip Classification 3 and 4.
- Persisting vomiting.
- History of previous liver disease.
- History of previous muscle disease or rabdomyolisis.
- Treated already with high dose atorvastatin
- Non Compliance.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00772564
|Rambam Health Care Campus
|Haifa, Israel, 31096 |
Rambam Health Care Campus
||Sammer Diab, MD, PhD
||Rambam Health Care Campus
No publications provided
||N_Krivoy, Clinical Pharmacology Unit, Rambam Health Care Campus
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 11, 2008
||May 25, 2012
||Israel: Israeli Health Ministry Pharmaceutical Administration
Keywords provided by Rambam Health Care Campus:
Acute ST Elevation Myocardial Infarction
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 11, 2013
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents