Full-dose Atorvastatin After Acute Coronary Syndrome (ACS) in Non-revascularisable Coronary Artery Disease (APRIRE)
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|ClinicalTrials.gov Identifier: NCT01187992|
Recruitment Status : Terminated (Interim analysis showed significant effect in favour of full-dose atorvastatin.)
First Posted : August 25, 2010
Last Update Posted : August 25, 2010
|Condition or disease||Intervention/treatment||Phase|
|Acute Coronary Syndrome Coronary Artery Disease||Drug: Atorvastatin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||290 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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 Start Date :||September 2003|
|Actual Primary Completion Date :||March 2007|
|Actual Study Completion Date :||April 2007|
Experimental: 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.
No Intervention: 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).
- Major adverse cardiovascular events [ Time Frame: 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.
- Cardiovascular mortality [ Time Frame: 12 months ]
- Non-fatal acute myocardial re-infarction (re-AMI) [ Time Frame: 12 months ]
- Disabling non-fatal stroke [ Time Frame: 12 months ]
- New-onset heart failure [ Time Frame: 12 months ]
- Atrial fibrillation [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01187992
|San Filippo Neri General Hospital|
|Rome, Italy, I-00135|
|Principal Investigator:||Furio Colivicchi, MD||Clinical Quality Mangement Unit, San Filippo Neri Hospital, Rome, Italy|