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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01187992
Recruitment Status : Terminated (Interim analysis showed significant effect in favour of full-dose atorvastatin.)
First Posted : August 25, 2010
Last Update Posted : August 25, 2010
Associazione Nazionale Medici Cardiologi Ospedalieri
Information provided by:
San Filippo Neri General Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Acute Coronary Syndrome Coronary Artery Disease Drug: Atorvastatin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : September 2003
Actual Primary Completion Date : March 2007
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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).

Primary Outcome Measures :
  1. Major adverse cardiovascular events [ Time Frame: 12 months ]
    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 :
  1. Cardiovascular mortality [ Time Frame: 12 months ]
  2. Non-fatal acute myocardial re-infarction (re-AMI) [ Time Frame: 12 months ]
  3. Disabling non-fatal stroke [ Time Frame: 12 months ]
  4. New-onset heart failure [ Time Frame: 12 months ]
  5. Atrial fibrillation [ Time Frame: 12 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Publications of Results:
Responsible Party: Prof. Furio Colivicchi, MD, FESC, Clinical Quality management Unit, Cardiovascular Department, San Filippo Neri Hospital, Rome Italy Identifier: NCT01187992     History of Changes
Other Study ID Numbers: SFN/02/03/AL
First Posted: August 25, 2010    Key Record Dates
Last Update Posted: August 25, 2010
Last Verified: May 2010

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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors