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Omega-3 Fatty Acid

Icosapent Ethyl 1000 MG Oral Capsule [Vascepa] for Cardiovascular Disease (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

IPE-PREVENTION Trial Summary

This trial will help researchers understand if a drug called icosapent ethyl can help prevent heart disease in people who are at risk.

Eligible Conditions

Cardiovascular Disease
Type 2 Diabetes
Cardiovascular Risk
High Triglycerides

IPE-PREVENTION Trial 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline - 3 months post-randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in the frequency of ALDHhiSSClowCD133+ cells in individuals treated with IPE compared to SOC for 3 months

Secondary outcome measures

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 more

Other outcome measures

Change in the mean frequency of ALDHhiSSChi cells in individuals treated with IPE compared to SOC for 3-months.

Change in the ratio of ALDHhiSSCmid pro-inflammatory:anti-inflammatory monocyte precursor cells in individuals treated with IPE compared to SOC for 3-months.

Changes in the concentration of serum inflammatory markers from baseline to the 3-month visit in individuals treated with IPE compared to SOC

+1 more

IPE-PREVENTION 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Western Ontario, CanadaOTHER

164 Previous Clinical Trials

319,176 Total Patients Enrolled

Unity Health TorontoOTHER

537 Previous Clinical Trials

447,469 Total Patients Enrolled

Canadian Medical and Surgical Knowledge Translation Research GroupLead Sponsor

8 Previous Clinical Trials

869 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What have the findings been regarding the security of Icosapent Ethyl 1000 MG Oral Capsule [Vascepa]?

"This medication has been approved, signifying its safety and earning it a score of 3."

Answered by AI

Are there any vacancies available to prospective participants in this experiment?

"As indicated on clinicaltrials.gov, the recruitment process for this trial is still ongoing; having been initially posted on September 24th 2020 and most recently updated on November 7th 2022."

Answered by AI

How many participants are currently being recruited for this experiment?

"Affirmative. The information on clinicaltrials.gov suggests that this research is currently looking for participants, the project having been posted in September 2020 and recently edited November 2022. 70 patients are to be enrolled from 3 medical centres."

Answered by AI

Recent research and studies

Journal of the American College of CardiologyJournal

Cardiometabolic-based Chronic Disease, Adiposity and Dysglycemia Drivers

Mechanick, Jeffrey I., Michael E. Farkouh, Jonathan D. Newman, and W. Timothy Garvey. 2020. “Cardiometabolic-based Chronic Disease, Adiposity and Dysglycemia Drivers”. Journal of the American College of Cardiology. Elsevier BV. doi:10.1016/j.jacc.2019.11.044.

Nature MedicineJournal

Angiogenesis in Health and Disease

Carmeliet, Peter. 2003. “Angiogenesis in Health and Disease”. Nature Medicine. Springer Science and Business Media LLC. doi:10.1038/nm0603-653.

Journal of Clinical InvestigationJournal

Angiogenesis and Vasculogenesis as Therapeutic Strategies for Postnatal Neovascularization

Isner, Jeffrey M., and Takayuki Asahara. 1999. “Angiogenesis and Vasculogenesis as Therapeutic Strategies for Postnatal Neovascularization”. Journal of Clinical Investigation. American Society for Clinical Investigation. doi:10.1172/jci6889.

Stem CellsJournal