The Use of Statins for Myocardial Death Prevention

Myocardial Infarction Clinical Trial

Official title:

The Use of Statins for Myocardial Death Prevention: From Cell to Bedside

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00772564
• Other study ID #: Ator2685Hdm2[2]
• Status: Completed
• Phase: Phase 4
• First received: October 11, 2008
• Last updated: May 25, 2012
• Start date: August 2008
• Est. completion date: August 2010

Study information

• Verified date: May 2012
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• Atorvastatin
Oral Atorvastatin

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa

Sponsors (2)

Lead Sponsor	Collaborator
Rambam Health Care Campus	Pfizer

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart EcoCardiography and specific laboratory tests		Base line, second day and 60 days after myocardial infarction	Yes