The Use of Icosapent Ethyl on Vascular Progenitor Cells in Individuals With Elevated Cardiovascul… (NCT04562467) | Clinical Trial Compass
CompletedPhase 4
The Use of Icosapent Ethyl on Vascular Progenitor Cells in Individuals With Elevated Cardiovascular Risk
Canada70 participantsStarted 2020-09-24
Plain-language summary
IPE-PREVENTION is a prospective, randomized, 3-month long, open-label study. A total of 70 individuals with elevated cardio-metabolic risk and heightened triglyceride levels, and who are on stable statin therapy will be randomized (1:1) to receive either icosapent ethyl (IPE) 2g BID or standard of care.
It is hypothesized that assignment to IPE will lower progenitor cell depletion as well as limit progenitor cell dysfunction. This study may offer some molecular and cellular insights into the mechanisms underlying the cardiovascular benefits of IPE therapy reported in the REDUCE-IT trial.
Who can participate
Age range40 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Women ≥65 years of age and men ≥40 years of age with established CVD (see criterion 'a' below) or ≥50 years of age with diabetes and one additional CV risk factor (see criterion 'b' below)
✓. Those with established CVD should have ≥1 of the following clinical history
✓. Those with a history of diabetes (either type 1 or type 2 diabetes mellitus) but no CVD should also have ≥1 of the following:
✓. Elevated triglycerides (≥1.5 mmol/L but \<5.6 mmol/L)
✓. On stable statin therapy for ≥4 weeks at the baseline visit
✓. Willing to provide written informed consent and be compliant with the study requirements
✓. Willing and able to follow the diet recommended by the study doctor
Exclusion criteria
✕. Participation in another clinical trial with an investigational agent ≤90 days prior to screening
✕. Women who are of childbearing potential
What they're measuring
1
Change in the frequency of ALDHhiSSClowCD133+ cells in individuals treated with IPE compared to SOC for 3 months
Timeframe: Baseline - 3 months post-randomization
Trial details
NCT IDNCT04562467
SponsorCanadian Medical and Surgical Knowledge Translation Research Group