Trial | NCT01187992  Report issue

Title

Full-dose Atorvastatin After Acute Coronary Syndrome (ACS) in Non-revascularisable Coronary Artery Disease
Full-dose Atorvastatin Versus Conventional Medical Therapy After Non-ST-elevation Acute Myocardial Infarction in Patients With Advanced Non-revascularisable Coronary Artery Disease

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    290
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.
Study Started
Sep 30
2003
Primary Completion
Mar 31
2007
Study Completion
Apr 30
2007
Last Update
Aug 25
2010
Estimate

Drug Atorvastatin

80 mg/day

Full-dose atorovastatin (80 mg/d) Experimental

For patients randomised to this arm, atorvastatin in the fixed dose of 80 mg/ day was started immediately after randomisation.

Conventional medical treatment No Intervention

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).

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.
No Results Posted