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

Phase 3

Terminated

• Conditions: Acute Coronary Syndrome; Coronary Artery Disease
• Interventions: Drug: Atorvastatin

• Registration Number: NCT01187992
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Primary Completion: 2007-03
• Study Completion: 2007-04
• Status Verified: 2010-05
• Study First Submitted: 2010-08-24
• Study First Submitted QC: 2010-08-24
• Last Update Submitted: 2010-08-24
• Study First Posted: 2010-08-25
• Last Update Posted: 2010-08-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 290

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Full-dose atorovastatin (80 mg/d)	Atorvastatin	For patients randomised to this arm, atorvastatin in the fixed dose of 80 mg/ day was started immediately after randomisation.

Primary Outcome Measures

Name	Time	Method
Major adverse cardiovascular events	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

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

Trial Locations

Locations (1)

San Filippo Neri General Hospital; 🇮🇹 Rome, Italy