Status:
TERMINATED
Eliminate Coronary Artery Disease
Lead Sponsor:
University Health Network, Toronto
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
35-59 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2019
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT02245087
Start Date
August 1 2014
End Date
September 1 2019
Last Update
June 1 2022
Active Locations (3)
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1
Dr. Killian De Blacam Family Medical Practice
Greater Sudbury, Ontario, Canada, P3A 2A3
2
Dr. Gregory Garrioch Family Medical Practice
Greater Sudbury, Ontario, Canada, P3E 3C6
3
Dr. Reena Dhatt
Greater Sudbury, Ontario, Canada, P3E6C3