NCT06710080

Targeting Vascular INflammation in Patients with Community-Acquired Pneumonia

Targeting Vascular INflammation in Patients with Community-Acquired Pneumonia (TIN_CAP): a Multi-centre, Prospective, Randomized Control Trial

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 168 (estimated)
• Sponsor: Ottawa Heart Institute Research Corporation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Inflammation
• Community Acquired Pneumonia (CAP)
• Inflammation Plaque, Atherosclerotic

Interventions

Type	Name	Description
DRUG	Icosapent Ethyl 1000 MG Oral Capsule [Vascepa]	Participants randomized to the treatment arm will receive Vascepa 1000mg twice a day for 6 months.
DRUG	Placebo	Placebo twice daily

Timeline

• Start date: 2024-12-15
• Primary completion: 2026-12-31
• Completion: 2027-06-01
• First posted: 2024-11-29
• Last updated: 2024-12-05

Locations

1 site across 1 country: Canada