Status:
COMPLETED
Generalizability of REDUCE-IT Results to People of South Asian Descent With Atherosclerotic Cardiovascular Disease in Canada (REDUCE-IT Canada SA)
Lead Sponsor:
Canadian Medical and Surgical Knowledge Translation Research Group
Collaborating Sponsors:
HLS Therapeutics, Inc
Conditions:
Cardiovascular Diseases
Atherosclerotic Cardiovascular Disease
Eligibility:
All Genders
45+ years
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 5 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 9 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05271591
Start Date
March 5 2022
End Date
April 9 2022
Last Update
March 27 2023
Active Locations (5)
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1
Scarborough Health Network
Ajax, Ontario, Canada, L1Z 0B1
2
Fenton Medical Centre
Markham, Ontario, Canada, L3R 7B4
3
North York Diagnostic and Cardiac Centre
North York, Ontario, Canada, M6B1N6
4
Legacy Medical Centre
Scarborough Village, Ontario, Canada, M1B 5K9