Effects of Atorvastatin on Myonecrosis

• Status: Terminated
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center
• Collaborator: Pfizer
• Treatments: Atorvastatin; Atorvastatin Calcium

Criteria

Inclusion Criteria:

• Patients must be aged 18 or over.

• Patients must provide written informed consent.

• Patients are presenting with unstable angina (defined as new onset chest pain, accelerating chest pain, chest pain at rest and ST-segment depression on the electrocardiogram [EKG])

• Patients undergoing successful coronary stent implantation of the (presumed) culprit lesion (defined as < 50% residual stenosis).

Exclusion Criteria:

• Any patient who is unable to give written informed consent.

• Any condition which, in the investigator's opinion, would interfere with optimal participation in the study or produce a significant risk to the patient.

• Patients presenting with an ST-elevation myocardial infarction (MI).

• Patients with elevated troponin, CK, or CK-MB (above the upper limit of normal).

• Patients already on high-dose statin therapy (defined as any statin equivalent to atorvastatin ≥ 40 mg).

• Patients who took any statin agent within 24 hours of presentation to the cardiac catheterization laboratory.

• Patients with active hepatic disease or myositis, in whom statin therapy is contraindicated.

• Patients with hypersensitivity to atorvastatin.

• Patients with procedural complications, including unsuccessful percutaneous transluminal coronary angioplasty (PTCA)/stenting, major side-branch occlusion, flow-limiting dissections at the completion of the procedure, emergent coronary artery bypass surgery, peri-procedural thrombus formation with distal embolization, stent thrombosis within the first 24 hours, repeat emergent PCI within 24 hours, and death within 24 hours.

• Cardiogenic shock.