The Use of Statins for Myocardial Death Prevention

NCT ID: NCT00772564

Last Updated: 2012-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-08-31

Brief Summary

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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

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Conditions

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Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Atorvastatin 80 mg

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type DRUG

Oral Atorvastatin

Atorvastatin 10 mg

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type DRUG

Oral Atorvastatin

Interventions

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Atorvastatin

Oral Atorvastatin

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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N_Krivoy

Clinical Pharmacology Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sammer Diab, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

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Rambam Health Care Campus

Haifa, Haifa District, Israel

Site Status

Countries

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Israel

Other Identifiers

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Ator2685Hdm2[2]

Identifier Type: -

Identifier Source: org_study_id

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