NCT05271591

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Canadian Medical and Surgical Knowledge Translation Research Group · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiovascular Diseases
• Atherosclerotic Cardiovascular Disease
• Myocardial Infarction
• Coronary Heart Disease

Timeline

• Start date: 2022-03-05
• Primary completion: 2022-04-09
• Completion: 2022-04-09
• First posted: 2022-03-09
• Last updated: 2023-03-27

Locations

5 sites across 1 country: Canada