Eliminate Coronary Artery Disease

Coronary Artery Disease Clinical Trial

— ECAD  

Official title:

Eliminate Coronary Artery Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02245087
• Other study ID #: ECAD001
• Status: Terminated
• Phase: Phase 2
• Start date: August 2014
• Est. completion date: September 2019

Study information

• Verified date: May 2022
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Atorvastatin
20 mg of atorvastatin daily

Locations

Country	Name	City	State
Canada	Dr. Gregory Garrioch Family Medical Practice	Sudbury	Ontario
Canada	Dr. Killian De Blacam Family Medical Practice	Sudbury	Ontario
Canada	Dr. Reena Dhatt	Sudbury	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first occurrence of myocardial infarction, revascularization, stroke or death from any cause in the follow up period		Up to 10 years