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Targeting Vascular INflammation in Patients with Community-Acquired Pneumonia (TIN_CAP): a Multi-centre, Prospective, Randomized Control Trial
The goal of this clinical trial is to learn if icosapent ethyl (Vascepa) works to lessen the amount of inflammation in adults diagnosed with Community-Acquired Pneumonia (CAP). The main question it aims to answer is: What is the effect of taking Vascepa on inflammation in the arteries in patients with CAP? Researchers will compare the drug Vascepa to a placebo (a look-alike submstance that contains no drug) to see if Vascepa works to reduce inflammation in patients with CAP. Participants wil: * take Vacscepa or a placebo twice a day for 6 months * Visit the clinic 3 times (baseline, 30 days, and 6 months) for checkups and tests
TIN CAP is a multi centre, prospective, randomized, double-blind, placebo-controlled clinical trial to evaluate the use of icosapent ethyl (Vascepa) on vascular inflammation in patients with CAP using FDG-PET/CT imaging and measurement of circulating biomarkers. The current proposal uses a randomized design to: 1. measure the effect of icosapent ethyl vs. placebo on reducing arterial inflammation over a 6-month treatment period, with primary analysis at 6-months; 2. the correlation between imaging and blood biomarkers over time relative to the drug response.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Start Date
December 15, 2024
Primary Completion Date
December 31, 2026
Completion Date
June 1, 2027
Last Updated
December 5, 2024
168
ESTIMATED participants
Icosapent Ethyl 1000 MG Oral Capsule [Vascepa]
DRUG
Placebo
DRUG
Lead Sponsor
Ottawa Heart Institute Research Corporation
NCT06200207
NCT04638647
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT00397280