Overview

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.