InflammationPhase 3TIN-CAPNCT06710080
Targeting Vascular INflammation in Patients With Community-Acquired Pneumonia
A Phase 3 study testing Icosapent Ethyl 1000 MG Oral Capsule [Vascepa] in people with Inflammation and Community Acquired Pneumonia (CAP), run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammation, Community Acquired Pneumonia (CAP), Inflammation Plaque, Atherosclerotic
- What is being tested?
- Icosapent Ethyl 1000 MG Oral Capsule [Vascepa]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 1 siteCanada
- Study dates
- 8 Apr 2026to Jun 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Kevin Boczar, 1-613-696-7000, kboczar@ottawaheart.ca
Ashley Cowan, BScN, 1-613-696-7000, acowan@ottawaheart.ca
About this study
Official title: 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
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:
- measure the effect of icosapent ethyl vs. placebo on reducing arterial inflammation over a 6-month treatment period, with primary analysis at 6-months;
- the correlation between imaging and blood biomarkers over time relative to the drug response.
- Being tested
- Icosapent Ethyl 1000 MG Oral Capsule [Vascepa], Placebo
- Keywords
- Community-Acquired Infection, Plaque, atherosclerotic, Inflammation, Eicosapentaenoic Acid
- Medical subject headings
- Inflammation, Community-Acquired Pneumonia, Community-Acquired Infections, Plaque, Atherosclerotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Icosapent Ethyl 1000 MG Oral Capsule [Vascepa]Drug
Participants randomized to the treatment arm will receive Vascepa 1000mg twice a day for 6 months.
PlaceboDrug
Placebo twice daily
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Participants randomized to this arm will receive Vascepa for 6 months. Receives: Drug: Icosapent Ethyl 1000 MG Oral Capsule [Vascepa] |
| Placebo | Placebo comparator | Participants randomized to this arm will receive placebo for 6 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change over 6 months in the FDG uptake TBR as a marker of arterial plaque inflammation between the icosapent ethyl and placebo groups
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start8 Apr 2026
- Primary completion31 Dec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin Boczar, MD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06710080
- Sponsor's protocol ID
- 2023
- Acronym
- TIN-CAP
- Status last verified
- May 2026
- First submitted
- 25 Nov 2024
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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