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

This study has been terminated.
(Interim analysis showed significant effect in favour of full-dose atorvastatin.)
Associazione Nazionale Medici Cardiologi Ospedalieri
Information provided by:
San Filippo Neri General Hospital
ClinicalTrials.gov Identifier:
First received: August 24, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted
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.

Condition Intervention Phase
Acute Coronary Syndrome
Coronary Artery Disease
Drug: Atorvastatin
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by San Filippo Neri General Hospital:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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 ]

Enrollment: 290
Study Start Date: September 2003
Study Completion Date: April 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01187992

San Filippo Neri General Hospital
Rome, Italy, I-00135
Sponsors and Collaborators
San Filippo Neri General Hospital
Associazione Nazionale Medici Cardiologi Ospedalieri
Principal Investigator: Furio Colivicchi, MD Clinical Quality Mangement Unit, San Filippo Neri Hospital, Rome, Italy
  More Information

Responsible Party: Prof. Furio Colivicchi, MD, FESC, Clinical Quality management Unit, Cardiovascular Department, San Filippo Neri Hospital, Rome Italy
ClinicalTrials.gov Identifier: NCT01187992     History of Changes
Other Study ID Numbers: SFN/02/03/AL 
Study First Received: August 24, 2010
Last Updated: August 24, 2010
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by San Filippo Neri General Hospital:
Acute coronary syndrome
Advanced coronary artery disease

Additional relevant MeSH terms:
Acute Coronary Syndrome
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Angina Pectoris
Arterial Occlusive Diseases
Cardiovascular Diseases
Chest Pain
Heart Diseases
Signs and Symptoms
Vascular Diseases
Anticholesteremic Agents
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on February 07, 2016