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Eliminate Coronary Artery Disease (ECAD)

This study is currently recruiting participants.
Verified May 2016 by Michael Farkouh, University Health Network, Toronto
Sponsor:
ClinicalTrials.gov Identifier:
NCT02245087
First Posted: September 19, 2014
Last Update Posted: May 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Michael Farkouh, University Health Network, Toronto
  Purpose
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.

Condition Intervention Phase
Coronary Artery Disease Drug: Atorvastatin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Eliminate Coronary Artery Disease

Resource links provided by NLM:


Further study details as provided by Michael Farkouh, University Health Network, Toronto:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 10000
Study Start Date: August 2014
Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Atorvastatin
Atorvastatin(Lipitor) in addition to the usual guideline based care
Drug: Atorvastatin
20 mg of atorvastatin daily
Other Name: Lipitor
No Intervention: Guideline based care
Current guidelines for lipid-management in healthy middle aged men and women only.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02245087


Contacts
Contact: Amanda Garrioch, BSc 416-340-4800 ext 2746 amanda.garrioch@uhn.ca

Locations
Canada, Ontario
Dr. Killian De Blacam Family Medical Practice Recruiting
Sudbury, Ontario, Canada, P3A 2A3
Contact: Amanda Garrioch, BSc       amanda.garrioch@uhn.ca   
Principal Investigator: Killian de Blacam, MD         
Dr. Gregory Garrioch Family Medical Practice Recruiting
Sudbury, Ontario, Canada, P3E 3C6
Contact: Amanda Garrioch, BSc       amanda.garrioch@uhn.ca   
Principal Investigator: Gregory F Garrioch, MD         
Dr. Reena Dhatt Recruiting
Sudbury, Ontario, Canada, P3E6C3
Principal Investigator: Reena Dhatt, MD FRCP CCFP         
Sponsors and Collaborators
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 Peter Munk Cardiac Centre, University Health Netowrk
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael Farkouh, Chair of the Peter Munk Centre of Excellence in Multinational Clinical Trials, Peter Munk Cardiac Centre, UHN, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02245087     History of Changes
Other Study ID Numbers: ECAD001
First Submitted: September 11, 2014
First Posted: September 19, 2014
Last Update Posted: May 12, 2016
Last Verified: May 2016

Keywords provided by Michael Farkouh, University Health Network, Toronto:
atorvastatin
coronary artery disease
myocardial infarction
stroke
revascularization

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors