NCT06710080 Targeting Vascular INflammation in Patients With Community-Acquired Pneumonia
| NCT ID | NCT06710080 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Ottawa Heart Institute Research Corporation |
| Condition | Inflammation |
| Study Type | INTERVENTIONAL |
| Enrollment | 168 participants |
| Start Date | 2026-04-08 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 168 participants in total. It began in 2026-04-08 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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
Contact & Investigator
Kevin Boczar, MD
PRINCIPAL INVESTIGATOR
Ottawa Heart Institute Research Corporation
Frequently Asked Questions
Who can join the NCT06710080 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Inflammation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06710080 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 168 participants.
Is NCT06710080 currently recruiting?
Yes, NCT06710080 is actively recruiting participants. Contact the research team at kboczar@ottawaheart.ca for enrollment information.
Where is the NCT06710080 trial being conducted?
This trial is being conducted at Ottawa, Canada.
Who is sponsoring the NCT06710080 clinical trial?
NCT06710080 is sponsored by Ottawa Heart Institute Research Corporation. The principal investigator is Kevin Boczar, MD at Ottawa Heart Institute Research Corporation. The trial plans to enroll 168 participants.