Coronary Artery Disease
Conditions
Keywords
atorvastatin, coronary artery disease, myocardial infarction, stroke, revascularization
Brief summary
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.
Interventions
20 mg of atorvastatin daily
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | 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 |
Countries
Canada