The Use of Statins for Myocardial Death Prevention

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
N_Krivoy, Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT00772564
First received: October 11, 2008
Last updated: May 25, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Myocardial Infarction
Drug: Atorvastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Use of Statins for Myocardial Death Prevention: From Cell to Bedside

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

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 ]

Enrollment: 25
Study Start Date: August 2008
Study Completion Date: August 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Atorvastatin 80 mg Drug: Atorvastatin
Oral Atorvastatin
Experimental: Atorvastatin 10 mg Drug: Atorvastatin
Oral Atorvastatin

  Eligibility

Ages Eligible for Study:   30 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00772564

Locations
Israel
Rambam Health Care Campus
Haifa, Israel, 31096
Sponsors and Collaborators
Rambam Health Care Campus
Pfizer
Investigators
Principal Investigator: Sammer Diab, MD, PhD Rambam Health Care Campus
  More Information

No publications provided

Responsible Party: N_Krivoy, Clinical Pharmacology Unit, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT00772564     History of Changes
Other Study ID Numbers: Ator2685Hdm2[2]
Study First Received: October 11, 2008
Last Updated: May 25, 2012
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Rambam Health Care Campus:
Acute ST Elevation Myocardial Infarction

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 16, 2014