Eliminate Coronary Artery Disease

Phase 2

Terminated

• Conditions: Coronary Artery Disease
• Interventions: Drug: Atorvastatin

• Registration Number: NCT02245087
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-09-11
• Study First Submitted QC: 2014-09-17
• Study First Posted: 2014-09-19
• Primary Completion: 2019-09
• Study Completion: 2019-09
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-27
• Last Update Posted: 2022-06-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atorvastatin	Atorvastatin	Atorvastatin(Lipitor) in addition to the usual guideline based care

Primary Outcome Measures

Name	Time	Method
Time to first occurrence of myocardial infarction, revascularization, stroke or death from any cause in the follow up period	Up to 10 years

Trial Locations

Locations (3)

Dr. Gregory Garrioch Family Medical Practice; 🇨🇦 Sudbury, Ontario, Canada

Dr. Killian De Blacam Family Medical Practice; 🇨🇦 Sudbury, Ontario, Canada

Dr. Reena Dhatt; 🇨🇦 Sudbury, Ontario, Canada