ClinicalTrials.gg
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.

Primary conditionCommunity-Acquired PneumoniaRegistry: InflammationReclassifiedWhy we changed it
Registry
Inflammation — the first condition term the registry derived for this study.
ClinicalTrials.gg
Community-Acquired Pneumonia
Why
  1. Inflammation is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name Community-Acquired Pneumonia.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

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

From the registry’s dates

  • Started Apr 2026; still recruiting 7 months later.
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

In context

Community-Acquired Pneumonia Reclassified

324 studies on the registry are indexed under Community-Acquired Pneumonia; 77 are open to participants now.

This study's planned enrollment of 168 is below the median of 250 across 195 interventional studies indexed under Community-Acquired Pneumonia.

Browse Community-Acquired Pneumonia studies →

Lead sponsor

Ottawa Heart Institute Research Corporation is the lead sponsor of 182 studies on the registry; 42 are open to participants now.

Compared within Community-Acquired Pneumonia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Inflammation. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

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 .

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 who refuse to use two forms of (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. (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

Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

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

06

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

07

Study locations

1 of 1 sites recruiting
08

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

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2026 (actual). Primary completion is estimated for Dec 2026, 8 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 25, 2024
First posted
Nov 29, 2024
StartActual
Apr 8, 2026
Primary completionEst.
Dec 31, 2026
CompletionEst.
Jun 2027
Last update
May 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06710080
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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