NCT05271591

Brief Summary

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®).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

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

First Submitted

Initial submission to the registry

February 28, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

March 5, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 9, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2022

Completed
Last Updated

March 27, 2023

Status Verified

March 1, 2023

Enrollment Period

1 month

First QC Date

February 28, 2022

Last Update Submit

March 24, 2023

Conditions

Cardiovascular DiseasesAtherosclerotic Cardiovascular DiseaseMyocardial InfarctionCoronary Heart Disease

Keywords

Icosapent EthylEthnic Origin

Outcome Measures

Primary Outcomes (1)

  • Proportion of study participants who meet the Health Canada-approved indication for icosapent ethyl [Product Monograph dated Dec 30, 2019]

    8 weeks

Secondary Outcomes (2)

  • Proportion of study participants whose demographic and biochemical data align with the corresponding baseline criteria of the REDUCE-IT cohort

    8 weeks

  • Proportion of study participants who have access to private and/or public coverage

    8 weeks

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Scarborough Health Network

Ajax, Ontario, L1Z 0B1, Canada

Location

Fenton Medical Centre

Markham, Ontario, L3R 7B4, Canada

Location

North York Diagnostic and Cardiac Centre

North York, Ontario, M6B1N6, Canada

Location

Legacy Medical Centre

Scarborough Village, Ontario, M1B 5K9, Canada

Location

Diagnostic Assessment Centre

Scarborough Village, Ontario, M1S4N6, Canada

Location

Related Publications (10)

  • Gupta M. Addressing atherosclerotic cardiovascular disease risk in South Asians: A daunting task ahead. Atherosclerosis. 2020 Dec;315:76-78. doi: 10.1016/j.atherosclerosis.2020.10.892. Epub 2020 Nov 4. No abstract available.

    PMID: 33172687BACKGROUND

  • Statistics Canada. Canada [Country] and Ontario [Province] (table). Census Profile. 2016 Census.2017 January 29, 2022. Available from: https://www12.statcan.gc.ca/census-recensement/2016/dp-pd/prof/index.cfm?Lang=E.

    BACKGROUND

  • Enas EA, Garg A, Davidson MA, Nair VM, Huet BA, Yusuf S. Coronary heart disease and its risk factors in first-generation immigrant Asian Indians to the United States of America. Indian Heart J. 1996 Jul-Aug;48(4):343-53.

    PMID: 8908818BACKGROUND

  • McKeigue PM, Marmot MG. Mortality from coronary heart disease in Asian communities in London. BMJ. 1988 Oct 8;297(6653):903. doi: 10.1136/bmj.297.6653.903. No abstract available.

    PMID: 3140974BACKGROUND

  • Balarajan R. Ethnic differences in mortality from ischaemic heart disease and cerebrovascular disease in England and Wales. BMJ. 1991 Mar 9;302(6776):560-4. doi: 10.1136/bmj.302.6776.560.

    PMID: 2021718BACKGROUND

  • Enas EA, Yusuf S, Mehta JL. Prevalence of coronary artery disease in Asian Indians. Am J Cardiol. 1992 Oct 1;70(9):945-9. doi: 10.1016/0002-9149(92)90744-j. No abstract available.

    PMID: 1529952BACKGROUND

  • Superko HR, Enas EA, Kotha P, Bhat NK, Garrett B. High-density lipoprotein subclass distribution in individuals of Asian Indian descent: the National Asian Indian Heart Disease Project. Prev Cardiol. 2005 Spring;8(2):81-6. doi: 10.1111/j.1520-037x.2005.3766.x.

    PMID: 15860982BACKGROUND

  • Bhardwaj S, Misra A, Misra R, Goel K, Bhatt SP, Rastogi K, Vikram NK, Gulati S. High prevalence of abdominal, intra-abdominal and subcutaneous adiposity and clustering of risk factors among urban Asian Indians in North India. PLoS One. 2011;6(9):e24362. doi: 10.1371/journal.pone.0024362. Epub 2011 Sep 20.

    PMID: 21949711BACKGROUND

  • Banerjee AT, Shah B. One Size Does Not Fit All: Diabetes Prevalence Among Immigrants of the South Asian Diaspora. J Immigr Minor Health. 2021 Aug;23(4):653-658. doi: 10.1007/s10903-020-01093-4. Epub 2020 Sep 29.

    PMID: 32990901BACKGROUND

  • Krishnaraj A, Bakbak E, Teoh H, Bhatt DL, Quan A, Puar P, Lambotharan B, Kirubaharan A, Firoz IN, Meglis G, Yanagawa B, Bari B, Kirubaharan R, Vijayaraghavan R, Hess DA, Demchuk AM, Mancini GBJ, Tanguay JF, Tardif JC, Voisine P, Leiter LA, Verma S. Generalizability of the REDUCE-IT trial to South Asians with cardiovascular disease. Med. 2023 Feb 10;4(2):130-138.e1. doi: 10.1016/j.medj.2022.12.008. Epub 2023 Jan 10.

    PMID: 36630964DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesAtherosclerosisMyocardial InfarctionCoronary Disease

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesMyocardial IschemiaHeart DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Subodh Verma, MD, PhD

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2022

First Posted

March 9, 2022

Study Start

March 5, 2022

Primary Completion

April 9, 2022

Study Completion

April 9, 2022

Last Updated

March 27, 2023

Record last verified: 2023-03

Locations

CA(5)