Clinical trial NCT05271591: Generalizability of REDUCE-IT Results to People of South Asian Descent With Atherosclerotic Cardiovascular Disease in Canada (REDUCE-IT Canada SA)
Official title: Generalizability of the REDUCE-IT Results to People of South Asian Descent With Known Atherosclerotic Cardiovascular Disease Living in Canada
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Atherosclerotic Cardiovascular Disease
Myocardial Infarction
Coronary Heart Disease
Keywords: Icosapent Ethyl
Ethnic Origin
Lead sponsor: Canadian Medical and Surgical Knowledge Translation Research Group
Sponsor class: OTHER
Collaborators: name: HLS Therapeutics, Inc
First posted: 2022-03-09
Enrollment: 200
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
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.

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®).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of study participants who meet the Health Canada-approved indication for icosapent ethyl [Product Monograph dated Dec 30, 2019]
timeFrame: 8 weeks
Secondary outcomes:
measure: Proportion of study participants whose demographic and biochemical data align with the corresponding baseline criteria of the REDUCE-IT cohort
timeFrame: 8 weeks
measure: Proportion of study participants who have access to private and/or public coverage
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Ajax
country: Canada
facility: Scarborough Health Network
state: Ontario
city: Markham
country: Canada
facility: Fenton Medical Centre
state: Ontario
city: North York
country: Canada
facility: North York Diagnostic and Cardiac Centre
state: Ontario
city: Scarborough
country: Canada
facility: Legacy Medical Centre
state: Ontario
city: Scarborough
country: Canada
facility: Diagnostic Assessment Centre
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Subodh Verma, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.