Targeting Vascular INflammation in Patients With Community-Acquired Pneumonia (TIN-CAP)

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

Study Overview

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

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 Type: Interventional
• Enrollment (Estimated): 168
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Kevin Boczar, MD; Phone Number: 1-613-696-7000; Email: kboczar@ottawaheart.ca
• Study Contact Backup: Name: Ashley Cowan, BScN; Phone Number: 1-613-696-7000; Email: acowan@ottawaheart.ca

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4W7
      • Recruiting
      • University of Ottawa Heart Institute
      • Contact: Kevin Boczar; Phone Number: 1-613-696-7000; Email: kboczar@ottawaheart.ca
      • Contact: Ashley Cowan, BScN; Phone Number: 1-613-696-7000; Email: acowan@ottawaheart.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Participants randomized to this arm will receive Vascepa for 6 months.	Drug: Icosapent Ethyl 1000 MG Oral Capsule [Vascepa]; Participants randomized to the treatment arm will receive Vascepa 1000mg twice a day for 6 months.
Placebo Comparator: Placebo; Participants randomized to this arm will receive placebo for 6 months.	Drug: Placebo; Placebo twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: Ottawa Heart Institute Research Corporation
• Investigators: Principal Investigator: Kevin Boczar, MD, Ottawa Heart Institute Research Corporation

Publications and helpful links

General Publications

• Stotts C, Corrales-Medina VF, deKemp RA, Wells GA, Beanlands R, Raggi P, Ferrara G, Sligl W, A Connelly K, Paul N, Brouwers M, Contreras-Dominguez V, Yadav K, Torres C, Tavoosi A, Wiefels C, Kirpalani A, Romsa JG, Grey B, Deva D, Rayner K, Boczar KE. Targeting Vascular Inflammation In Patients with Community-Acquired Pneumonia (TIN-CAP): protocol for a multicentre, randomised, double-blind, placebo-controlled trial. BMJ Open. 2026 Mar 4;16(3):e114239. doi: 10.1136/bmjopen-2025-114239.

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: November 25, 2024
• First Submitted That Met QC Criteria: November 25, 2024
• First Posted (Actual): November 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Inflammation; Eicosapentaenoic Acid; Community-Acquired Infection; Plaque, atherosclerotic
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Anatomical; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Pneumonia; Pathological Conditions, Signs and Symptoms; Inflammation; Plaque, Atherosclerotic; Community-Acquired Infections; Community-Acquired Pneumonia; Platelet Aggregation Inhibitors; Lipid Regulating Agents; eicosapentaenoic acid ethyl ester
• Other Study ID Numbers: 2023 (GRAMMY Museum Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No