Reducing artery inflammation after community-acquired pneumonia

Targeting Vascular INflammation in Patients With Community-Acquired Pneumonia (TIN_CAP): a Multi-centre, Prospective, Randomized Control Trial

This trial will test whether taking Vascepa twice daily for six months can reduce artery inflammation in adults hospitalized with community-acquired pneumonia.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 168 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ottawa Heart Institute Research Corporation (other)
• Drugs / interventions: methotrexate, prednisone
• Locations: 1 site (Ottawa, Ontario)
• Trial ID: NCT06710080 on ClinicalTrials.gov

What this trial studies

TIN CAP is a randomized, double-blind, placebo-controlled Phase 3 trial that gives adults with community-acquired pneumonia either icosapent ethyl (Vascepa) or a matching placebo twice daily for six months. Arterial inflammation will be measured with FDG-PET/CT imaging at baseline and after six months, alongside serial blood biomarkers to track systemic inflammatory changes. Participants attend three clinic visits (baseline, 30 days, and six months) for imaging, blood tests, and safety monitoring. The design compares changes in imaging and circulating biomarkers between the Vascepa and placebo groups to determine drug-related effects on vascular inflammation.

Who should consider this trial

Good fit: Adults over 18 who were hospitalized with community-acquired pneumonia, can provide informed consent, and meet the study's safety criteria (for example not pregnant and without recent cancer or active systemic inflammatory disease).

Not a fit: People with recent cancer, active autoimmune or inflammatory conditions, pregnant or breastfeeding women, or those unwilling to use required contraception are excluded and would not be expected to benefit from participation.

Why it matters

Potential benefit: If successful, Vascepa could reduce arterial inflammation after pneumonia and possibly lower short-term cardiovascular risk linked to infection.

How similar studies have performed: Icosapent ethyl has shown cardiovascular benefits and anti-inflammatory effects in prior cardiovascular trials, but its specific use to reduce arterial inflammation after pneumonia is novel and not yet established.

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

Where this trial is running

Ottawa, Ontario

• University of Ottawa Heart Institute — Ottawa, Ontario, Canada (RECRUITING)

Study contacts

• Principal investigator: Kevin Boczar, MD — Ottawa Heart Institute Research Corporation
• Study coordinator: Kevin Boczar, MD

Conditions: Inflammation, Community Acquired Pneumonia, Inflammation Plaque, Atherosclerotic, Community-Acquired Infection, Plaque, atherosclerotic, Eicosapentaenoic Acid