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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.)
Sponsor:
Collaborator:
Associazione Nazionale Medici Cardiologi Ospedalieri, Sezione Lazio
Information provided by:
San Filippo Neri General Hospital
ClinicalTrials.gov Identifier:
NCT01187992
First received: August 24, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted
  Purpose

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:

U.S. FDA Resources

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01187992

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

Publications:

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:
Atorvastatin
Acute coronary syndrome
Advanced coronary artery disease

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

ClinicalTrials.gov processed this record on May 19, 2013