Eliminate Coronary Artery Disease (ECAD)

May 27, 2022 updated by: Michael Farkouh, University Health Network, Toronto
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Sudbury, Ontario, Canada, P3A 2A3
        • Dr. Killian De Blacam Family Medical Practice
      • Sudbury, Ontario, Canada, P3E 3C6
        • Dr. Gregory Garrioch Family Medical Practice
      • Sudbury, Ontario, Canada, P3E6C3
        • Dr. Reena Dhatt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 59 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Atorvastatin
Atorvastatin(Lipitor) in addition to the usual guideline based care
Drug: Atorvastatin
20 mg of atorvastatin daily
Other Names:
  • Lipitor
No Intervention: Guideline based care
Current guidelines for lipid-management in healthy middle aged men and women only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Dr Michael Farkouh, MD, FRCPC, MSc, FACC, Peter Munk Cardiac Centre, University Health Network
  • Principal Investigator: Michael J Domanski, MD, University of Maryland Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2014

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

September 11, 2014

First Submitted That Met QC Criteria

September 17, 2014

First Posted (Estimate)

September 19, 2014

Study Record Updates

Last Update Posted (Actual)

June 1, 2022

Last Update Submitted That Met QC Criteria

May 27, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECAD001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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