Targeting Vascular INflammation in Patients with Community-Acquired Pneumonia

Phase 3

Not yet recruiting

• Conditions: Inflammation; Community Acquired Pneumonia (CAP); Inflammation Plaque, Atherosclerotic
• Interventions: Drug: Icosapent Ethyl 1000 MG Oral Capsule [Vascepa]; Drug: Placebo

• Registration Number: NCT06710080
• Lead Sponsor: Ottawa Heart Institute Research Corporation

Brief 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.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-11-25
• Study First Submitted QC: 2024-11-25
• Study First Posted: 2024-11-29
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-05
• Study Start: 2024-12-15
• Primary Completion: 2026-12-31
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

Patients who have:

1. Hospitalization with CAP (defined as pulmonary infiltration using chest imaging, in addition to other clinical symptoms including fever, cough, and sputum)
2. age > 18 years;
3. given informed consent.

Exclusion Criteria

Patients who have:

1. history of cancer within the last 3 years (other than a successfully treated cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix).
2. active inflammatory conditions (e.g. rheumatoid arthritis, chronic inflammatory bowel disease, SLE, systemic anti-inflammatory therapy (e.g. prednisone, methotrexate));
3. pregnancy (all women of child bearing potential will have a negative BHCG test;
4. breastfeeding;
5. Women of childbearing potential who refuse to use two forms of contraception (this includes at least one form of highly effective and one effective method of contraception) throughout the study OR men capable of fathering a child who refuse to use contraception.
6. Allergies to icosapent ethyl
7. allergies to fish or shellfish
8. glomerular filtration rate (GFR) <50 ml/min/1.72m2 (excluded from CTA portion)
9. unable to give informed consent;

Exclusion for CTA portion of the protocol:

Patients with dye allergy will not undergo CTA but will have PET/CT

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Icosapent Ethyl 1000 MG Oral Capsule [Vascepa]	Participants randomized to this arm will receive Vascepa for 6 months.
Placebo	Placebo	Participants randomized to this arm will receive placebo for 6 months.

Primary Outcome Measures

Name	Time	Method
The change over 6 months in the FDG uptake TBR as a marker of arterial plaque inflammation between the icosapent ethyl and placebo groups	6 months

Secondary Outcome Measures

Name	Time	Method
The change in inflammation, measured on FDG PET, in the pulmonary tissue.	6 months	The change in background-corrected measure of total metabolic activity (total pulmonary glycolytic activity) will be measured.

Trial Locations

Locations (1)

University of Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada