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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05271591
• Other study ID #: Pro00061124
• Status: Completed
• Start date: March 5, 2022
• Est. completion date: April 9, 2022

Study information

• Verified date: March 2023
• Source: Canadian Medical and Surgical Knowledge Translation Research Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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®).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 9, 2022
• Est. primary completion date: April 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerotic Cardiovascular Disease
• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Infarction
• Myocardial Infarction
• Myocardial Ischemia

Locations

Country	Name	City	State
Canada	Scarborough Health Network	Ajax	Ontario
Canada	Fenton Medical Centre	Markham	Ontario
Canada	North York Diagnostic and Cardiac Centre	North York	Ontario
Canada	Diagnostic Assessment Centre	Scarborough	Ontario
Canada	Legacy Medical Centre	Scarborough	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Canadian Medical and Surgical Knowledge Translation Research Group	HLS Therapeutics, Inc

Country where clinical trial is conducted

Canada, 

References & Publications (9)

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. — View 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. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of study participants who meet the Health Canada-approved indication for icosapent ethyl [Product Monograph dated Dec 30, 2019]		8 weeks
Secondary	Proportion of study participants whose demographic and biochemical data align with the corresponding baseline criteria of the REDUCE-IT cohort		8 weeks
Secondary	Proportion of study participants who have access to private and/or public coverage		8 weeks