Generalizability of REDUCE-IT Results to People of South Asian Descent With Atherosclerotic Cardiovascular Disease in Canada (REDUCE-IT Canada SA)

March 24, 2023 updated by: Canadian Medical and Surgical Knowledge Translation Research Group

Generalizability of the REDUCE-IT Results to People of South Asian Descent With Known Atherosclerotic Cardiovascular Disease Living in Canada

The REDUCE-IT Canada SA Study is a cross-sectional study aiming to determine the proportion of study participants who meet the Health Canada-approved indication for icosapent ethyl (IPE;Vascepa®).

Study Overview

Status

Completed

Conditions

Detailed Description

Global derived data indicate that compared to most ethnicities, people of South Asian (SA) descent shoulder a heavier burden and mortality rate for atherosclerotic cardiovascular disease (ASCVD). They are younger at the time of first hospitalization for heart failure and exhibit more high-risk features upon discharge. Canadian data indicate that SAs presented to the hospital later during acute myocardial infarction and are more likely to have an anterior location of infarction. They also tend to be younger at the time of cardiac catheterization than those of European descent and are more likely to have significant left main, multivessel, and distal coronary artery disease. SAs appear to have comparatively pro-atherosclerotic lipid profiles - more small dense LDL particles, lower HDL-C levels, and hypertriglyceridemia - and demonstrate a higher prevalence of diabetes, metabolic syndrome, central adiposity and inflammation.

People of SA descent are markedly underrepresented in clinical trials, and it remains unclear as to whether many of the life-saving therapies are generalizable to this population. The REDUCE-IT Canada SA Study aims to determine the generalizability of the REDUCE-IT study results to people of South Asian descent with known ASCVD living in Canada. Specifically, the study will ascertain the proportion of South Asian individuals that meet the Health Canada indication for IPE; the alignment of the participants' baseline characteristics with those of the REDUCE-IT cohort; the proportion of study participants who have access to private and/or public coverage.

Study Type

Observational

Enrollment (Actual)

200

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
      • Ajax, Ontario, Canada, L1Z 0B1
        • Scarborough Health Network
      • Markham, Ontario, Canada, L3R 7B4
        • Fenton Medical Centre
      • North York, Ontario, Canada, M6B1N6
        • North York Diagnostic and Cardiac Centre
      • Scarborough, Ontario, Canada, M1B 5K9
        • Legacy Medical Centre
      • Scarborough, Ontario, Canada, M1S4N6
        • Diagnostic Assessment Centre

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

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants will be identified from primary care and cardiology outpatient clinics in the Greater Toronto Area using paper-based and electronic medical records.

Description

Inclusion Criteria:

  • Adults 45 years of age or older of SA descent i. A person of SA descent is any individual who self-identifies as Anglo-Indian, Bangladeshi, Bengali, Bhutanese, Goan, Gujarati, Indian, Jatt, Kashmiri, Maharashtrian, Malayali, Nepali, Pakistani, Punjabi, Sindhi, Sinhalese, Sri Lankan, Tamil, Telugu, or other SA descent

  • History of ASCVD within the preceding 10 years defined as:

    i. Documented CAD (defined as having experienced a prior MI, coronary artery bypass grafting, percutaneous coronary intervention) ii. Documented cerebrovascular disease (defined as having experienced a prior stroke, transient ischemic attack or carotid revascularization) iii. Documented peripheral artery disease (ankle-brachial index <0.9, or peripheral revascularization)

  • On stable statin therapy
  • Has had routine bloodwork within 3 years prior to enrolment- Willing and able to provide verbal or written informed consent

Exclusion Criteria:

  • Severe congestive heart failure (as defined by New York Heart Association Class IV)
  • Any life-threatening disease expected to result in death within the next 2 years
  • Any malignancy not considered cured (except basal cell carcinoma of the skin) An individual is considered cured if there has been no evidence of cancer recurrence for the 5 years prior to screening
  • Known severe liver disease
  • Known acquired immunodeficiency syndrome such as human immunodeficiency virus infection
  • Use of omega-3 fatty acid supplements, fish oil, or icosapent ethyl

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

  • Observational Models: Case-Only
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of study participants who meet the Health Canada-approved indication for icosapent ethyl [Product Monograph dated Dec 30, 2019]
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of study participants whose demographic and biochemical data align with the corresponding baseline criteria of the REDUCE-IT cohort
Time Frame: 8 weeks
8 weeks
Proportion of study participants who have access to private and/or public coverage
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

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

Sponsor

Canadian Medical and Surgical Knowledge Translation Research Group

Collaborators

HLS Therapeutics, Inc

Investigators

  • Principal Investigator: Subodh Verma, MD, PhD, Unity Health Toronto

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)

March 5, 2022

Primary Completion (Actual)

April 9, 2022

Study Completion (Actual)

April 9, 2022

Study Registration Dates

First Submitted

February 28, 2022

First Submitted That Met QC Criteria

February 28, 2022

First Posted (Actual)

March 9, 2022

Study Record Updates

Last Update Posted (Actual)

March 27, 2023

Last Update Submitted That Met QC Criteria

March 24, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00061124

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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