A LARGE PRAGMATIC TRIAL OF STATINS IN PRIMARY PREVENTION: THE NEXT FRONTIER
Michael Farkouh, M.D., Cardiac Centre, University of Toronto, Toronto, Canada
Atherothrombotic disease is the most common cause of death in the world. Pharmacologic LDL lowering has been shown to reduce coronary heart disease (CHD) events according to the LDL level achieved with no demonstrated level below which events do not decrease with additional LDL lowering. Further, available data suggest that the earlier the LDL lowering occurs, the greater the therapeutic effect of a given decrease.
Objective: The purpose of the proposed study (Elimination of Coronary Artery Disease [ECAD]) is to determine whether pharmacologic lowering of serum low density lipoprotein cholesterol (LDL), initiated in healthy young to middle-aged adults, can eliminate, or markedly reduce CAD.
Study design: ECAD is a randomized, multicenter, primary prevention clinical trial designed to compare a strategy of usual guideline based lipid management to a strategy of LDL lowering medication (atorvastatin 20 mg daily) for the primary prevention of atherothrombotic events (all cause death, excluding those due to cancer and trauma, myocardial infarction, stroke, or coronary revascularization) in healthy middle aged men and women.
Study subjects are men 35 to 50 years of age and women of non-child bearing potential 45 to 59 years of age without any prior history of CHD, stroke, or peripheral vascular disease who have one additional risk factor (hypertension and waist circumference >100 cm in men or >90 cm in women, family history of premature coronary atherosclerosis, or smoking) and LDL from 1.8 mmol/l ( 70 mg/dL) to the minimum LDL for which the current ACC/AHA Guidelines recommend pharmacologic treatment in the presence of a single additional risk factor.
Intervention or Treatment: Usual guideline-based therapy versus usual guideline-based therapy with the addition of atorvastatin 20 mg daily.
Sample Size: A total of 15,000 patients will be recruited to participate in this trial from 300 primary care practices.