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

Full-dose Atorvastatin Versus Conventional Medical Therapy After Non-ST-elevation Acute Myocardial Infarction in Patients With Advanced Non-revascularisable Coronary Artery Disease

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.

Study Overview

• Status: Terminated
• Conditions: Coronary Artery Disease; Acute Coronary Syndrome
• Intervention / Treatment: Drug: Atorvastatin

• Study Type: Interventional
• Enrollment (Actual): 290
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, I-00135
    • San Filippo Neri General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Atorvastatin; 80 mg/day
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiovascular events	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.	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Cardiovascular mortality	12 months
Non-fatal acute myocardial re-infarction (re-AMI)	12 months
Disabling non-fatal stroke	12 months
New-onset heart failure	12 months
Atrial fibrillation	12 months

Collaborators and Investigators

• Sponsor: San Filippo Neri General Hospital
• Collaborators: Associazione Nazionale Medici Cardiologi Ospedalieri
• Investigators: Principal Investigator: Furio Colivicchi, MD, Clinical Quality Mangement Unit, San Filippo Neri Hospital, Rome, Italy

Publications and helpful links

General Publications

• Colivicchi F, Tubaro M, Mocini D, Genovesi Ebert A, Strano S, Melina G, Uguccioni M, Santini M. Full-dose atorvastatin versus conventional medical therapy after non-ST-elevation acute myocardial infarction in patients with advanced non-revascularisable coronary artery disease. Curr Med Res Opin. 2010 Jun;26(6):1277-84. doi: 10.1185/03007991003751496.

Study record dates

Study Major Dates

• Study Start: September 1, 2003
• Primary Completion (ACTUAL): March 1, 2007
• Study Completion (ACTUAL): April 1, 2007

Study Registration Dates

• First Submitted: August 24, 2010
• First Submitted That Met QC Criteria: August 24, 2010
• First Posted (ESTIMATE): August 25, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): August 25, 2010
• Last Update Submitted That Met QC Criteria: August 24, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: Acute coronary syndrome; Atorvastatin; Advanced coronary artery disease
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Disease; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Syndrome; Acute Coronary Syndrome; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• Other Study ID Numbers: SFN/02/03/AL