Targeting Vascular INflammation in Patients With Community-Acquired Pneumonia

NCT06710080 | Recruiting Phase 3 DMC

• 1 other identifier: 2023
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Community-Acquired Infection; Plaque, atherosclerotic; Inflammation; Eicosapentaenoic Acid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The change in inflammation, measured on FDG PET, in the pulmonary tissue.

  6 months

Study Arms (2)

Treatment

EXPERIMENTAL

Participants randomized to this arm will receive Vascepa for 6 months.

Drug: Icosapent Ethyl 1000 MG Oral Capsule [Vascepa]

Placebo

PLACEBO COMPARATOR

Participants randomized to this arm will receive placebo for 6 months.

Drug: Placebo

Interventions

Placebo DRUG

Placebo twice daily

Placebo

Icosapent Ethyl 1000 MG Oral Capsule [Vascepa] DRUG

Participants randomized to the treatment arm will receive Vascepa 1000mg twice a day for 6 months.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have:
• Hospitalization with CAP (defined as pulmonary infiltration using chest imaging, in addition to other clinical symptoms including fever, cough, and sputum)
• age \> 18 years;
• given informed consent.

You may not qualify if:

• Patients who have:
• 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).
• active inflammatory conditions (e.g. rheumatoid arthritis, chronic inflammatory bowel disease, SLE, systemic anti-inflammatory therapy (e.g. prednisone, methotrexate));
• pregnancy (all women of child bearing potential will have a negative BHCG test;
• breastfeeding;
• 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.
• Allergies to icosapent ethyl
• allergies to fish or shellfish
• glomerular filtration rate (GFR) \<50 ml/min/1.72m2 (excluded from CTA portion)
• unable to give informed consent;
• Patients with dye allergy will not undergo CTA but will have PET/CT

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 41781043 DERIVED

MeSH Terms

Conditions

Inflammation; Community-Acquired Pneumonia; Community-Acquired Infections; Plaque, Atherosclerotic

Interventions

eicosapentaenoic acid ethyl ester

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases; Pathological Conditions, Anatomical

Central Study Contacts

Kevin Boczar, MD

CONTACT

1-613-696-7000; kboczar@ottawaheart.ca

Poppy MacPhee, BScN

CONTACT

1-613-696-7000; pmacphee@ottawaheart.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 29, 2024
• Study Start: April 8, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

CA (1)