| Trial ID: | L3785 |
| Source ID: | NCT04562467
|
| Associated Drug: |
Icosapent Ethyl 1000 Mg Oral Capsule [Vascepa]
|
| Title: |
The Use of Icosapent Ethyl on Vascular Progenitor Cells in Individuals With Elevated Cardiovascular Risk
|
| Acronym: |
IPE-PREVENTION
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Cardiovascular Diseases|Cardiovascular Risk Factor|Triglycerides High|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Icosapent Ethyl 1000 MG Oral Capsule [Vascepa]
|
| Outcome Measures: |
Primary: Change in the frequency of ALDHhiSSClowCD133+ cells in individuals treated with IPE compared to SOC for 3 months, Baseline - 3 months post-randomization | Other: Change in the ratio of ALDHhiSSCmid pro-inflammatory:anti-inflammatory monocyte precursor cells in individuals treated with IPE compared to SOC for 3-months., Baseline - 3 months post-randomization|Change in the mean frequency of ALDHhiSSChi cells in individuals treated with IPE compared to SOC for 3-months., Baseline - 3 months post-randomization|Changes in the concentration of serum oxidative stress markers from baseline to the 3-month visit in individuals treated with IPE compared to SOC, Baseline - 3 months post-randomization|Changes in the concentration of serum inflammatory markers from baseline to the 3-month visit in individuals treated with IPE compared to SOC, Baseline - 3 months post-randomization
|
| Sponsor/Collaborators: |
Sponsor: Canadian Medical and Surgical Knowledge Translation Research Group | Collaborators: HLS Therapeutics, Inc|Unity Health Toronto|Western University, Canada
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
70
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2020-09-24
|
| Completion Date: |
2023-05-25
|
| Results First Posted: |
|
| Last Update Posted: |
2024-04-02
|
| Locations: |
The Oshawa Clinic, Oshawa, Ontario, L1H 1B9, Canada|Diagnostic Assessment Centre, Scarborough, Ontario, M1S4N6, Canada|Langstaff Medical Clinic, Vaughan, Ontario, L4L 0K8, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT04562467
|
