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Trial record 1 of 1 for:    NCT00772564
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The Use of Statins for Myocardial Death Prevention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 11, 2008
First Posted Date  ICMJE October 15, 2008
Last Update Posted Date May 28, 2012
Study Start Date  ICMJE August 2008
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2008)
Heart EcoCardiography and specific laboratory tests [ Time Frame: Base line, second day and 60 days after myocardial infarction ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Use of Statins for Myocardial Death Prevention
Official Title  ICMJE The Use of Statins for Myocardial Death Prevention: From Cell to Bedside
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Myocardial Infarction
Intervention  ICMJE Drug: Atorvastatin
Oral Atorvastatin
Study Arms  ICMJE
  • Experimental: Atorvastatin 80 mg
    Intervention: Drug: Atorvastatin
  • Experimental: Atorvastatin 10 mg
    Intervention: Drug: Atorvastatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 25, 2012)
25
Original Estimated Enrollment  ICMJE
 (submitted: October 14, 2008)
60
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00772564
Other Study ID Numbers  ICMJE Ator2685Hdm2[2]
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party N_Krivoy, Rambam Health Care Campus
Study Sponsor  ICMJE Rambam Health Care Campus
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Sammer Diab, MD, PhD Rambam Health Care Campus
PRS Account Rambam Health Care Campus
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP