Coronary Artery DiseasePhase 2ECADNCT02245087
Eliminate Coronary Artery Disease
A Phase 2 study testing Atorvastatin in people with Coronary Artery Disease, run by University Health Network, Toronto at 3 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 35 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 3 sitesCanada
- Study dates
- Aug 2014to Sep 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Dr. Killian De Blacam Family Medical Practice
Greater Sudbury, Ontario, P3A 2A3
Dr. Gregory Garrioch Family Medical Practice
Greater Sudbury, Ontario, P3E 3C6
Dr. Reena Dhatt
Greater Sudbury, Ontario, P3E6C3
About this study
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.
- Conditions
- Coronary Artery Disease
- Being tested
- Atorvastatin
- Keywords
- atorvastatin, coronary artery disease, myocardial infarction, stroke, revascularization
- Medical subject headings
- Coronary Artery Disease, Myocardial Infarction, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Also called Lipitor
20 mg of atorvastatin daily
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin | Experimental | Atorvastatin(Lipitor) in addition to the usual guideline based care Receives: Drug: Atorvastatin |
| Guideline based care | No intervention | Current guidelines for lipid-management in healthy middle aged men and women only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first occurrence of myocardial infarction, revascularization, stroke or death from any cause in the follow up period
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionSep 2019
- Study completionSep 2019
Why it stopped: Lack of Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Farkouh, University Health Network, Toronto
- Investigators
- Dr Michael Farkouh, MD, FRCPC, MSc, FACC, Principal investigator, Peter Munk Cardiac Centre, University Health NetworkMichael J Domanski, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02245087
- Sponsor's protocol ID
- ECAD001
- Acronym
- ECAD
- Status last verified
- May 2022
- First submitted
- 11 Sep 2014
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26483108
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eliminate Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT02245087
- Acronym / sponsor ID
- ECAD / ECAD001
- Conditions
- Coronary Artery Disease
- Keywords
- atorvastatin, coronary artery disease, myocardial infarction, stroke, revascularization
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of Funding
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Aug 2014 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 19 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin | Experimental | Drug: AtorvastatinAtorvastatin(Lipitor) in addition to the usual guideline based care |
| Guideline based care | No intervention | –Current guidelines for lipid-management in healthy middle aged men and women only. |
Who may qualify
- Ages
- 35 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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]
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtorvastatinAlso: Lipitor20 mg of atorvastatin daily | Drug | Atorvastatin |
Primary outcome
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
Results and safety
The study was stopped early (reason given: Lack of Funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Derived from this study: PubMed 26483108Domanski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Michael Farkouh, MD, FRCPC, MSc, FACC principal investigator
Peter Munk Cardiac Centre, University Health Network
Michael J Domanski, MD principal investigator
University of Maryland, Baltimore
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atorvastatin in people with Coronary Artery Disease, run by University Health Network, Toronto at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of Funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02245087, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.