Full-dose Atorvastatin After Acute Coronary Syndrome (ACS) in Non-revascularisable Coronary Artery Disease (APRIRE)
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.
Acute Coronary Syndrome
Coronary Artery Disease
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Full-dose Atorvastatin Versus Conventional Medical Therapy After Non-ST-elevation Acute Myocardial Infarction in Patients With Advanced Non-revascularisable Coronary Artery Disease|
- Major adverse cardiovascular events [ Time Frame: 12 months ] [ Designated as safety issue: No ]The primary end point of the study was prospectively defined as the combination of cardiovascular death, non-fatal acute myocardial re-infarction (re-AMI) and disabling non-fatal stroke.
- Cardiovascular mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Non-fatal acute myocardial re-infarction (re-AMI) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Disabling non-fatal stroke [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- New-onset heart failure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Atrial fibrillation [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||September 2003|
|Study Completion Date:||April 2007|
|Primary Completion Date:||March 2007 (Final data collection date for primary outcome measure)|
Experimental: Full-dose atorovastatin (80 mg/d)
For patients randomised to this arm, atorvastatin in the fixed dose of 80 mg/ day was started immediately after randomisation.
No Intervention: Conventional medical treatment
For patients randomised to this arm, adherence to the National Cholesterol Education Program, Adult Treatment Panel III guidelines was required. In particular, in these patients,atorvastatin was started at the initial dosage of 20 mg/day immediately after randomisation. Subsequently, atorvastatin dosage was titrated in order to attain low-density lipoprotein cholesterol (LDL-C) levels <100 mg/dL (2.5 mmol/L).
|San Filippo Neri General Hospital|
|Rome, Italy, I-00135|
|Principal Investigator:||Furio Colivicchi, MD||Clinical Quality Mangement Unit, San Filippo Neri Hospital, Rome, Italy|