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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01187992

Acronym

APRIRE

Enrollment

290

Registered

2010-08-25

Start date

2003-09-30

Completion date

2007-04-30

Last updated

2010-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome, Coronary Artery Disease

Keywords

Atorvastatin, Acute coronary syndrome, Advanced coronary artery disease

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.

Interventions

DRUGAtorvastatin

80 mg/day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026