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The Use of Statins for Myocardial Death Prevention

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ClinicalTrials.gov Identifier: NCT00772564
Recruitment Status : Completed
First Posted : October 15, 2008
Last Update Posted : May 28, 2012
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
N_Krivoy, Rambam Health Care Campus

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Drug: Atorvastatin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Use of Statins for Myocardial Death Prevention: From Cell to Bedside
Study Start Date : August 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : August 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Atorvastatin 80 mg Drug: Atorvastatin
Oral Atorvastatin
Experimental: Atorvastatin 10 mg Drug: Atorvastatin
Oral Atorvastatin


Outcome Measures
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Primary Outcome Measures :
  1. Heart EcoCardiography and specific laboratory tests [ Time Frame: Base line, second day and 60 days after myocardial infarction ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00772564


Locations
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Israel
Rambam Health Care Campus
Haifa, Israel, 31096
Sponsors and Collaborators
Rambam Health Care Campus
Pfizer
Investigators
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Principal Investigator: Sammer Diab, MD, PhD Rambam Health Care Campus
More Information
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Responsible Party: N_Krivoy, Clinical Pharmacology Unit, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT00772564    
Other Study ID Numbers: Ator2685Hdm2[2]
First Posted: October 15, 2008    Key Record Dates
Last Update Posted: May 28, 2012
Last Verified: May 2012
Keywords provided by N_Krivoy, Rambam Health Care Campus:
Acute ST Elevation Myocardial Infarction
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
 Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors