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

Coronary Artery Disease Clinical Trial

— APRIRE  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01187992
• Other study ID #: SFN/02/03/AL
• Status: Terminated
• Phase: Phase 3
• First received: August 24, 2010
• Last updated: August 24, 2010
• Start date: September 2003
• Est. completion date: April 2007

Study information

• Verified date: May 2010
• Source: San Filippo Neri General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 290
• Est. completion date: April 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Atorvastatin
80 mg/day

Locations

Country	Name	City	State
Italy	San Filippo Neri General Hospital	Rome

Sponsors (2)

Lead Sponsor	Collaborator
San Filippo Neri General Hospital	Associazione Nazionale Medici Cardiologi Ospedalieri

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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 co — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Cardiovascular mortality		12 months	No
Secondary	Non-fatal acute myocardial re-infarction (re-AMI)		12 months	No
Secondary	Disabling non-fatal stroke		12 months	No
Secondary	New-onset heart failure		12 months	No
Secondary	Atrial fibrillation		12 months	No