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

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Coronary Syndrome, Coronary Artery Disease

Intervention / Treatment
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* Drug: Atorvastatin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Full-dose atorovastatin (80 mg/d)<br>For patients randomised to this arm, atorvastatin in the fixed dose of 80 mg/ day was started immediately after randomisation. | Drug: Atorvastatin<br>* 80 mg/day<br>|
| No Intervention: Conventional medical treatment<br>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). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atorvastatin, Acute coronary syndrome, Advanced coronary artery disease