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RecruitingNCT06710080TIN-CAPUpdated May 11, 2026

Targeting Vascular INflammation in Patients With Community-Acquired Pneumonia

A Phase 3 interventional study of Icosapent Ethyl 1000 MG Oral Capsule [Vascepa] and Placebo in Inflammation, Community Acquired Pneumonia (CAP) and Inflammation Plaque, Atherosclerotic, sponsored by Ottawa Heart Institute Research Corporation. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-11.

Sponsored by Ottawa Heart Institute Research Corporation · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
168
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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
Read the 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.
02

Conditions studied

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

Keywords

  • Community-Acquired Infection
  • Plaque, atherosclerotic
  • Inflammation
  • Eicosapentaenoic Acid
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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

04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
168 participants (estimated)

Study arms

  • Experimental
    Treatment

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

    Drug: Icosapent Ethyl 1000 MG Oral Capsule [Vascepa]

  • Placebo comparator
    Placebo

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

    Drug: Placebo

Interventions

  • DrugIcosapent Ethyl 1000 MG Oral Capsule [Vascepa]

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

  • DrugPlacebo

    Placebo twice daily

05

What researchers measure

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

    Time frame: 6 months

Secondary outcomes

  1. 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.

    Time frame: 6 months

06

Study locations

1 of 1 sites recruiting
  • University of Ottawa Heart Institute
    Ottawa, Ontario K1Y 4W7, Canada
    Recruiting
07

References and documents

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. PubMed 41781043 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT06710080
Lead sponsor
Ottawa Heart Institute Research Corporation
Responsible party
Sponsor
First posted
Nov 29, 2024
Start date
Apr 8, 2026
Primary completion
Dec 31, 2026 (estimated)
Completion
Jun 2027 (estimated)
Last update
May 11, 2026

Study contacts

Kevin Boczar, MD
Contact
kboczar@ottawaheart.ca
1-613-696-7000
Ashley Cowan, BScN
Contact
acowan@ottawaheart.ca
1-613-696-7000
Kevin Boczar, MD
principal investigator · Ottawa Heart Institute Research Corporation

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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