NCT00772564

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 15, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

May 28, 2012

Status Verified

May 1, 2012

Enrollment Period

1.8 years

First QC Date

October 11, 2008

Last Update Submit

May 25, 2012

Conditions

Myocardial Infarction

Keywords

Acute ST Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • Heart EcoCardiography and specific laboratory tests

    Base line, second day and 60 days after myocardial infarction

Study Arms (2)

Atorvastatin 80 mg

EXPERIMENTAL
Drug: Atorvastatin

Atorvastatin 10 mg

EXPERIMENTAL
Drug: Atorvastatin

Interventions

AtorvastatinDRUG

Oral Atorvastatin

Atorvastatin 10 mgAtorvastatin 80 mg

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Care Campus

Haifa, Haifa District, 31096, Israel

Location

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Sammer Diab, MD, PhD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Pharmacology Unit

Study Record Dates

First Submitted

October 11, 2008

First Posted

October 15, 2008

Study Start

August 1, 2008

Primary Completion

June 1, 2010

Study Completion

August 1, 2010

Last Updated

May 28, 2012

Record last verified: 2012-05

Locations

IL(1)