Eliminate Coronary Artery Disease

Study Overview
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Brief Summary
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The purpose of this study is to determine whether pharmacologic lowering of low density lipoprotein cholesterol (LDL), initiated in healthy young to middle aged adults can eliminate or markedly reduce the composite endpoint of incident all cause mortality, myocardial infarction, stroke or coronary revascularization.

Official Title
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Eliminate Coronary Artery Disease

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Atorvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men 35-50 years of age Women 45 - 59 years of age (must be sterile or >2 years postmenopausal) LDL cholesterol greater than 1.8 mmol/L (70 mg/dL) based on testing performed within 1 year One risk factor for Coronary Heart Disease other than lipid abnormality: Obesity and hypertension [BP >140 mmHg systolic and waist circumference > 100 cm in men and >90 cm in women] family history of premature myocardial infarction [<60 years] South Asian ethnic history currently smoking Exclusion Criteria: Currently taking cholesterol lowering medication Qualify for cholesterol lowering medication based on current guidelines Significant renal dysfunction (creatinine clearance <30 ml/min) Significant hepatic dysfunction (AST/ALT >2.0 times upper limit of normal) Active malignancy Diabetes Progressive or terminal illness, or other condition in which subject is unlikely to survive the study period Known allergy, hypersensitivity (anaphylaxis) ar adverse reaction to any statin Participation in a clinical trial (except observational studies) within previous 30 days Received any investigation product within 30 days prior to participation in this clinical trial Previously enrolled in this clinical trial

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atorvastatin<br>Atorvastatin(Lipitor) in addition to the usual guideline based care | Drug: Atorvastatin<br>* 20 mg of atorvastatin daily<br>* Other names: Lipitor;|
| No Intervention: Guideline based care<br>Current guidelines for lipid-management in healthy middle aged men and women only. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first occurrence of myocardial infarction, revascularization, stroke or death from any cause in the follow up period |  | Up to 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, atorvastatin, coronary artery disease, myocardial infarction, revascularization