Reducing artery inflammation after community-acquired pneumonia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: kboczar@ottawaheart.ca
• Phone: 1-613-696-7000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.