NCT02245087

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_2 coronary-artery-disease

Timeline
Completed

Started Aug 2014

Longer than P75 for phase_2 coronary-artery-disease

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 11, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2014

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

June 1, 2022

Status Verified

May 1, 2022

Enrollment Period

5.1 years

First QC Date

September 11, 2014

Last Update Submit

May 27, 2022

Conditions

Coronary Artery Disease

Keywords

atorvastatincoronary artery diseasemyocardial infarctionstrokerevascularization

Outcome Measures

Primary Outcomes (1)

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

    Up to 10 years

Study Arms (2)

Atorvastatin

EXPERIMENTAL

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

Drug: Atorvastatin

Guideline based care

NO INTERVENTION

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

Interventions

AtorvastatinDRUG

20 mg of atorvastatin daily

Also known as: Lipitor
Atorvastatin

Eligibility Criteria

Age35 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Dr. Killian De Blacam Family Medical Practice

Greater Sudbury, Ontario, P3A 2A3, Canada

Location

Dr. Gregory Garrioch Family Medical Practice

Greater Sudbury, Ontario, P3E 3C6, Canada

Location

Dr. Reena Dhatt

Greater Sudbury, Ontario, P3E6C3, Canada

Location

Related Publications (1)

  • 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.

    PMID: 26483108DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial InfarctionStroke

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Dr Michael Farkouh, MD, FRCPC, MSc, FACC

    Peter Munk Cardiac Centre, University Health Network

    PRINCIPAL INVESTIGATOR

  • Michael J Domanski, MD

    University of Maryland, Baltimore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair of the Peter Munk Centre of Excellence in Multinational Clinical Trials, Peter Munk Cardiac Centre, UHN

Study Record Dates

First Submitted

September 11, 2014

First Posted

September 19, 2014

Study Start

August 1, 2014

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

June 1, 2022

Record last verified: 2022-05

Locations

CA(3)