Full-dose Atorvastatin After Acute Coronary Syndrome (ACS) in Non-revascularisable Coronary Artery Disease

• Status: Terminated
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study was designed to test the hypothesis that the addition of full-dose atorvastatin (80 mg/day) to conventional medical treatment could reduce ischaemic recurrences after non-ST-elevation acute myocardial infarction (NSTE-AMI) in patients with severe and diffuse coronary artery disease (CAD) not amenable to any form of mechanical revascularisation.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: San Filippo Neri General Hospital
• Collaborator: Associazione Nazionale Medici Cardiologi Ospedalieri
• Treatments: Atorvastatin; Atorvastatin Calcium

Criteria

Inclusion Criteria:

• non-ST-segment elevation acute myocardial infarction.

• coronary angiography within 48 hours from admission.

• angiographic evidence of severe and diffuse coronary artery disease,not amenable to conventional direct revascularisation techniques by coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI).

Exclusion Criteria:

• ST-segment elevation acute myocardial infarction,

• clinical history of heart failure

• left ventricular ejection fraction <35%,

• any form of severe valvular dysfunction,

• previous implantation or indication to implant a cardioverter-defibrillator during the index admission,

• any increase in liver enzymes,

• history of any liver or muscle disease,

• renal failure with serum creatinine >2.5 mg/dL (221 mmol/L),

• need for continued use of intravenous medications to relieve anginal symptoms,

• presence of any major comorbidity with life expectancy <24 months.