Clinical trial NCT01187992: Full-dose Atorvastatin After Acute Coronary Syndrome (ACS) in Non-revascularisable Coronary Artery Disease
Official title: Full-dose Atorvastatin Versus Conventional Medical Therapy After Non-ST-elevation Acute Myocardial Infarction in Patients With Advanced Non-revascularisable Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Acute Coronary Syndrome
Coronary Artery Disease
Keywords: Atorvastatin
Acute coronary syndrome
Advanced coronary artery disease
Lead sponsor: San Filippo Neri General Hospital
Sponsor class: OTHER
Collaborators: name: Associazione Nazionale Medici Cardiologi Ospedalieri
First posted: 2010-08-25
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Major adverse cardiovascular events
timeFrame: 12 months
Secondary outcomes:
measure: Cardiovascular mortality
timeFrame: 12 months
measure: Non-fatal acute myocardial re-infarction (re-AMI)
timeFrame: 12 months
measure: Disabling non-fatal stroke
timeFrame: 12 months
measure: New-onset heart failure
timeFrame: 12 months
measure: Atrial fibrillation
timeFrame: 12 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: San Filippo Neri General Hospital
Study officials:
affiliation: Clinical Quality Mangement Unit, San Filippo Neri Hospital, Rome, Italy
name: Furio Colivicchi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Colivicchi F, Tubaro M, Mocini D, Genovesi Ebert A, Strano S, Melina G, Uguccioni M, Santini M. Full-dose atorvastatin versus conventional medical therapy after non-ST-elevation acute myocardial infarction in patients with advanced non-revascularisable coronary artery disease. Curr Med Res Opin. 2010 Jun;26(6):1277-84. doi: 10.1185/03007991003751496.