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

Overview

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.

Full Title of Study: “Full-dose Atorvastatin Versus Conventional Medical Therapy After Non-ST-elevation Acute Myocardial Infarction in Patients With Advanced Non-revascularisable Coronary Artery Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: March 2007

Interventions

  • Drug: Atorvastatin
    • 80 mg/day

Arms, Groups and Cohorts

  • 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.
  • 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).

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • San Filippo Neri General Hospital
  • Collaborator
    • Associazione Nazionale Medici Cardiologi Ospedalieri
  • Provider of Information About this Clinical Study
    • Prof. Furio Colivicchi, MD, FESC, Clinical Quality management Unit, Cardiovascular Department, San Filippo Neri Hospital, Rome Italy
  • Overall Official(s)
    • Furio Colivicchi, MD, Principal Investigator, Clinical Quality Mangement Unit, San Filippo Neri Hospital, Rome, Italy

Citations Reporting on Results

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.

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