Eliminate Coronary Artery Disease (ECAD)

University Health Network, Toronto

Status and phase

Terminated

Phase 2

Conditions

Coronary Artery Disease

Treatments

Drug: Atorvastatin

Study type

Interventional

Funder types

Other

Identifiers

NCT02245087

ECAD001

Details and patient eligibility

About

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.

Enrollment

28 patients

Sex

All

Ages

35 to 59 years old

Volunteers

Accepts Healthy Volunteers

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