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Omega-3 Fatty Acid
The Use of Icosapent Ethyl on Vascular Progenitor Cells in Individuals With Elevated Cardiovascular Risk (IPE-PREVENTION Trial)
Phase 4
Waitlist Available
Led By Subodh Verma, MD, PhD
Research Sponsored by Canadian Medical and Surgical Knowledge Translation Research Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline - 3 months post-randomization
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial tests whether taking icosapent ethyl (IPE), an omega-3 fatty acid, regularly can help people with high heart disease risk and high triglycerides who are already on statins. The study aims to see if IPE can reduce inflammation and improve the function of cells that repair blood vessels. This could help lower the risk of heart problems. Icosapent ethyl (IPE) is a high-purity prescription form of eicosapentaenoic acid (EPA) ethyl ester, approved in 2012 to reduce triglyceride levels in patients with severe hypertriglyceridemia.
Eligible Conditions
- Cardiovascular Disease
- Cardiovascular Risk
- Diabetes
- Type 2 Diabetes
- High Triglycerides
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline - 3 months post-randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline - 3 months post-randomization
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
20% change in the mean frequency of ALDHhiSSCloCD133+ cells with pro-vascular progenitor cells phenotype in individuals treated with IPE compared to SOC for 3-months.
Stem cells
40% change in the ratio of M1:M2 monocyte precursor cells in individuals treated with IPE compared to SOC for 3-months. M1 monocyte precursor cells defined as ALDHhiSSCmidCD14+CD86+ and M2 monocyte precursor cells defined as ALDHhiSSCmidCD14+CD163+
+1 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Icosapent Ethyl + Standard of CareExperimental Treatment1 Intervention
Icosapent Ethyl 1000 MG Oral Capsule \[Vascepa\] 2 x 1g capsules BID (4g total) as per REDUCE-IT
Group II: Standard of CareActive Control1 Intervention
Standard of care therapy (including statin therapy as per inclusion criteria)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Icosapent Ethyl 1000 MG Oral Capsule [Vascepa]
2020
Completed Phase 4
~70
Find a Location
Who is running the clinical trial?
University of Western Ontario, CanadaOTHER
166 Previous Clinical Trials
319,288 Total Patients Enrolled
Unity Health TorontoOTHER
562 Previous Clinical Trials
453,881 Total Patients Enrolled
Canadian Medical and Surgical Knowledge Translation Research GroupLead Sponsor
10 Previous Clinical Trials
949 Total Patients Enrolled
Western University, CanadaOTHER
254 Previous Clinical Trials
59,216 Total Patients Enrolled
HLS Therapeutics, IncUNKNOWN
2 Previous Clinical Trials
300 Total Patients Enrolled
Subodh Verma, MD, PhDPrincipal InvestigatorUnity Health Toronto
8 Previous Clinical Trials
1,016 Total Patients Enrolled
Deepak L Bhatt, MD, MPHStudy ChairBrigham and Women's Hospital, Boston, Massachusetts
1 Previous Clinical Trials
535 Total Patients Enrolled
David A Hess, PhDPrincipal InvestigatorRobarts Research Institute, London, Ontario
7 Previous Clinical Trials
458 Total Patients Enrolled