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The Use of Icosapent Ethyl on Vascular Progenitor Cells in Individuals With Elevated Cardiovascular Risk

NCT04562467 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-04-02

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Icosapent Ethyl 1000 MG Oral Capsule [Vascepa]

2 x 1g capsules BID as per REDUCE-IT

Sponsors & Collaborators

  • HLS Therapeutics, Inc

    collaborator UNKNOWN

  • Unity Health Toronto

    collaborator OTHER

  • Western University, Canada

    collaborator OTHER

  • Canadian Medical and Surgical Knowledge Translation Research Group

    lead OTHER

Principal Investigators

  • Subodh Verma, MD, PhD · Unity Health Toronto

  • David A Hess, PhD · Robarts Research Institute, London, Ontario

  • Deepak L Bhatt, MD, MPH · Brigham and Women's Hospital, Boston, Massachusetts

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-24
Primary Completion
2023-05-25
Completion
2023-05-25

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04562467 on ClinicalTrials.gov