Clinical trial NCT02245087: Eliminate Coronary Artery Disease
Official title: Eliminate Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Coronary Artery Disease
Keywords: atorvastatin
coronary artery disease
myocardial infarction
stroke
revascularization
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2014-09-19
Enrollment: 28
Sex: ALL
Minimum age (years): 35
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to first occurrence of myocardial infarction, revascularization, stroke or death from any cause in the follow up period
timeFrame: Up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sudbury
country: Canada
facility: Dr. Killian De Blacam Family Medical Practice
state: Ontario
city: Sudbury
country: Canada
facility: Dr. Gregory Garrioch Family Medical Practice
state: Ontario
city: Sudbury
country: Canada
facility: Dr. Reena Dhatt
state: Ontario
Study officials:
affiliation: Peter Munk Cardiac Centre, University Health Network
name: Dr Michael Farkouh, MD, FRCPC, MSc, FACC
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland, Baltimore
name: Michael J Domanski, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Domanski MJ, Fuster V, Diaz-Mitoma F, Grundy S, Lloyd-Jones D, Mamdani M, Roberts R, Thorpe K, Hall J, Udell JA, Farkouh ME. Next Steps in Primary Prevention of Coronary Heart Disease: Rationale for and Design of the ECAD Trial. J Am Coll Cardiol. 2015 Oct 20;66(16):1828-1836. doi: 10.1016/j.jacc.2015.08.857.