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

San Filippo Neri General Hospital

Status and phase: Terminated; Phase 3

Conditions: Coronary Artery Disease; Acute Coronary Syndrome

Treatments: Drug: Atorvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01187992

SFN/02/03/AL

Details and patient eligibility

About

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.

Enrollment: 290 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

290 participants in 2 patient groups

Full-dose atorovastatin (80 mg/d)

Experimental group

Description:

For patients randomised to this arm, atorvastatin in the fixed dose of 80 mg/ day was started immediately after randomisation.

Treatment:

Drug: Atorvastatin

Conventional medical treatment

No Intervention group

Description:

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).