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临床试验/NCT05271591
NCT05271591已完成不适用

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

Canadian Medical and Surgical Knowledge Translation Research Group5 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年3月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
5
主要终点
Proportion of study participants who meet the Health Canada-approved indication for icosapent ethyl [Product Monograph dated Dec 30, 2019]

研究概览

简要总结

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®).

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Other

入排标准

年龄范围
45 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: 8 weeks

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (5)

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