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The Use of Statins for Myocardial Death Prevention

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Atorvastatin
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myocardial Infarction focused on measuring Acute ST Elevation Myocardial Infarction

Eligibility Criteria

30 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Rambam Health Care Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Atorvastatin 80 mg

Atorvastatin 10 mg

Arm Description

Outcomes

Primary Outcome Measures

Heart EcoCardiography and specific laboratory tests

Secondary Outcome Measures

Full Information

First Posted
October 11, 2008
Last Updated
May 25, 2012
Sponsor
Rambam Health Care Campus
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00772564
Brief Title
The Use of Statins for Myocardial Death Prevention
Official Title
The Use of Statins for Myocardial Death Prevention: From Cell to Bedside
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rambam Health Care Campus
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Acute ST Elevation Myocardial Infarction

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atorvastatin 80 mg
Arm Type
Experimental
Arm Title
Atorvastatin 10 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
Oral Atorvastatin
Primary Outcome Measure Information:
Title
Heart EcoCardiography and specific laboratory tests
Time Frame
Base line, second day and 60 days after myocardial infarction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sammer Diab, MD, PhD
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel

12. IPD Sharing Statement

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The Use of Statins for Myocardial Death Prevention

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