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Effects of Atorvastatin on Myonecrosis

NCT00344019 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2018-01-02

Study results available
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Summary

This study is designed as a prospective, randomized, placebo-controlled, double-blind analysis of atorvastatin 80 mg versus placebo administered on average 4 hours prior to percutaneous coronary intervention \[PCI\] (at least 2 hours) in patients presenting with unstable angina. Only patients with negative cardiac biomarkers, measured on 2 separate occasions a few hours apart will be eligible for inclusion. Furthermore, patients already on high-dose statin therapy; patients taking any statin within 24 hours prior to the PCI; and patients with contraindications to statins will be excluded from the study. The primary endpoint is a quantitative troponin level at 18-24 hours after PCI. At an enrollment of a total of 150 patients (75 per group), the study is powered to detect a 30% difference in troponin level. Secondary endpoints include elevation of creatine kinase (CK) and CK-MB above the upper limit of normal, change in C-reactive protein (CRP) levels from baseline and thrombolysis in myocardial infarction (TIMI) myocardial perfusion grade. All patients will be started on statin therapy the day after the procedure, as deemed appropriate by their treating physicians.

Conditions

  • Coronary Disease

Interventions

DRUG

Placebo Oral Tablet

placebo pre-PCI for ACS

DRUG

Atorvastatin 80mg

atorvastatin 80 mg pre-angio/PCI

OTHER

Screening

Patients signed consent to be screened for eligibility for randomization to placebo vs. study drug (atorvastatin)

Sponsors & Collaborators

Principal Investigators

  • Joseph Carrozza, Jr, MD · Beth Israel Deaconess Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2008-10-31
Completion
2009-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00344019 on ClinicalTrials.gov