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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

290 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2007-04-30

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.

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Detailed Description

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Conditions

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Acute Coronary Syndrome Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type DRUG

80 mg/day

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Atorvastatin

80 mg/day

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No