Back to resultsFull-dose Atorvastatin After Acute Coronary Syndrome (ACS) in Non-revascularisable Coronary Artery Disease (APRIRE)
Primary Purpose
Acute Coronary Syndrome, Coronary Artery Disease
Status
Terminated
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Atorvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Atorvastatin, Acute coronary syndrome, Advanced coronary artery disease
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.
Sites / Locations
- San Filippo Neri General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Full-dose atorovastatin (80 mg/d)
Conventional medical treatment
Arm Description
For patients randomised to this arm, atorvastatin in the fixed dose of 80 mg/ day was started immediately after randomisation.
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Cardiovascular mortality
Non-fatal acute myocardial re-infarction (re-AMI)
Disabling non-fatal stroke
New-onset heart failure
Atrial fibrillation
Full Information
NCT ID
NCT01187992
First Posted
August 24, 2010
Last Updated
August 24, 2010
Sponsor
San Filippo Neri General Hospital
Collaborators
Associazione Nazionale Medici Cardiologi Ospedalieri
1. Study Identification
Unique Protocol Identification Number
NCT01187992
Brief Title
Full-dose Atorvastatin After Acute Coronary Syndrome (ACS) in Non-revascularisable Coronary Artery Disease
Acronym
APRIRE
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
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Terminated
Why Stopped
Interim analysis showed significant effect in favour of full-dose atorvastatin.
Study Start Date
September 2003 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
San Filippo Neri General Hospital
Collaborators
Associazione Nazionale Medici Cardiologi Ospedalieri
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Coronary Artery Disease
Keywords
Atorvastatin, Acute coronary syndrome, Advanced coronary artery disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
290 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Full-dose atorovastatin (80 mg/d)
Arm Type
Experimental
Arm Description
For patients randomised to this arm, atorvastatin in the fixed dose of 80 mg/ day was started immediately after randomisation.
Arm Title
Conventional medical treatment
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
80 mg/day
Primary Outcome Measure Information:
Title
Major adverse cardiovascular events
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Cardiovascular mortality
Time Frame
12 months
Title
Non-fatal acute myocardial re-infarction (re-AMI)
Time Frame
12 months
Title
Disabling non-fatal stroke
Time Frame
12 months
Title
New-onset heart failure
Time Frame
12 months
Title
Atrial fibrillation
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Furio Colivicchi, MD
Organizational Affiliation
Clinical Quality Mangement Unit, San Filippo Neri Hospital, Rome, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Filippo Neri General Hospital
City
Rome
ZIP/Postal Code
I-00135
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
20367555
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.
Results Reference
result
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Full-dose Atorvastatin After Acute Coronary Syndrome (ACS) in Non-revascularisable Coronary Artery Disease
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