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Interim analysis showed significant effect in favour of full-dose atorvastatin.
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| Name | Class |
|---|---|
| Associazione Nazionale Medici Cardiologi Ospedalieri | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full-dose atorovastatin (80 mg/d) | Experimental | For patients randomised to this arm, atorvastatin in the fixed dose of 80 mg/ day was started immediately after randomisation. |
|
| Conventional medical treatment | No Intervention | 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug | 80 mg/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular mortality | 12 months | |
| Non-fatal acute myocardial re-infarction (re-AMI) | 12 months | |
| Disabling non-fatal stroke |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Furio Colivicchi, MD | Clinical Quality Mangement Unit, San Filippo Neri Hospital, Rome, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Filippo Neri General Hospital | Rome | Italy | I-00135 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20367555 | Result | 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. |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 12 months |
| New-onset heart failure | 12 months |
| Atrial fibrillation | 12 months |
| D003327 |
| Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |