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Cardiovascular DiseasesNCT05271591

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

An observational study of Cardiovascular Diseases and Atherosclerotic Cardiovascular Disease, run by Canadian Medical and Surgical Knowledge Translation Research Group at 5 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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®). Read more about this study

Who is it for?
Ages 45 years and older
How many people
200 participants
Where
5 sitesCanada
Study dates
5 Mar 2022to 9 Apr 2022
Phase
Observational
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 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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:
  • 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

Who cannot join

  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Canada5 sites

  • Scarborough Health Network

    Ajax, Ontario, L1Z 0B1

  • Fenton Medical Centre

    Markham, Ontario, L3R 7B4

  • North York Diagnostic and Cardiac Centre

    North York, Ontario, M6B1N6

  • Legacy Medical Centre

    Scarborough Village, Ontario, M1B 5K9

  • Diagnostic Assessment Centre

    Scarborough Village, Ontario, M1S4N6

Other trials in Canada

About this study

Official title: 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®).

Read the 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.

Keywords
Icosapent Ethyl, Ethnic Origin
Medical subject headings
Cardiovascular Diseases, Atherosclerosis, Myocardial Infarction, Coronary Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 8 weeks

Secondary outcomes (2)

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

    Measured: 8 weeks

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

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2022
  2. Study start5 Mar 2022
  3. Primary completion9 Apr 2022
  4. Study completion9 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Other
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05271591
Sponsor's protocol ID
Pro00061124
Status last verified
Mar 2023
First submitted
28 Feb 2022
Last updated
27 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 33172687

  • 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.

  • 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.

    PubMed 8908818

  • 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.

    PubMed 3140974

  • 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.

    PubMed 2021718

  • 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.

    PubMed 1529952

  • 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.

    PubMed 15860982

  • 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.

    PubMed 21949711

  • 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.

    PubMed 32990901

  • 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.

    PubMed 36630964

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Diseases and Atherosclerotic Cardiovascular Disease, run by Canadian Medical and Surgical Knowledge Translation Research Group at 5 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Proportion of study participants who meet the Health Canada-approved indication for icosapent ethyl [Product Monograph dated Dec 30, 2019] (time frame: 8 weeks). 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 NCT05271591, which also lists 10 linked publications.

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 27 Mar 2023.

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