search
Back to results

Eliminate Coronary Artery Disease (ECAD)

Primary Purpose

Coronary Artery Disease

Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Atorvastatin
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease focused on measuring atorvastatin, coronary artery disease, myocardial infarction, stroke, revascularization

Eligibility Criteria

35 Years - 59 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Dr. Killian De Blacam Family Medical Practice
  • Dr. Gregory Garrioch Family Medical Practice
  • Dr. Reena Dhatt

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Atorvastatin

Guideline based care

Arm Description

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

Current guidelines for lipid-management in healthy middle aged men and women only.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 11, 2014
Last Updated
May 27, 2022
Sponsor
University Health Network, Toronto
search

1. Study Identification

Unique Protocol Identification Number
NCT02245087
Brief Title
Eliminate Coronary Artery Disease
Acronym
ECAD
Official Title
Eliminate Coronary Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
Lack of Funding
Study Start Date
August 2014 (Actual)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
September 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
atorvastatin, coronary artery disease, myocardial infarction, stroke, revascularization

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atorvastatin
Arm Type
Experimental
Arm Description
Atorvastatin(Lipitor) in addition to the usual guideline based care
Arm Title
Guideline based care
Arm Type
No Intervention
Arm Description
Current guidelines for lipid-management in healthy middle aged men and women only.
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Other Intervention Name(s)
Lipitor
Intervention Description
20 mg of atorvastatin daily
Primary Outcome Measure Information:
Title
Time to first occurrence of myocardial infarction, revascularization, stroke or death from any cause in the follow up period
Time Frame
Up to 10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Michael Farkouh, MD, FRCPC, MSc, FACC
Organizational Affiliation
Peter Munk Cardiac Centre, University Health Network
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael J Domanski, MD
Organizational Affiliation
University of Maryland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Killian De Blacam Family Medical Practice
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3A 2A3
Country
Canada
Facility Name
Dr. Gregory Garrioch Family Medical Practice
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 3C6
Country
Canada
Facility Name
Dr. Reena Dhatt
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E6C3
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
26483108
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.
Results Reference
derived

Learn more about this trial

Eliminate Coronary Artery Disease

We'll reach out to this number within 24 hrs