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

Completed

• Conditions: Cardiovascular Diseases; Coronary Heart Disease; Myocardial Infarction; Atherosclerotic Cardiovascular Disease

• Registration Number: NCT05271591
• Lead Sponsor: Canadian Medical and Surgical Knowledge Translation Research Group

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.

Study Timeline

• Study First Submitted: 2022-02-28
• Study First Submitted QC: 2022-02-28
• Study Start: 2022-03-05
• Study First Posted: 2022-03-09
• Primary Completion: 2022-04-09
• Study Completion: 2022-04-09
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-24
• Last Update Posted: 2023-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Scarborough Health Network; 🇨🇦 Ajax, Ontario, Canada

Fenton Medical Centre; 🇨🇦 Markham, Ontario, Canada

North York Diagnostic and Cardiac Centre; 🇨🇦 North York, Ontario, Canada

Legacy Medical Centre; 🇨🇦 Scarborough, Ontario, Canada

Diagnostic Assessment Centre; 🇨🇦 Scarborough, Ontario, Canada