Recruiting
Phase 3

Icosapent Ethyl

Sponsor:

Ottawa Heart Institute Research Corporation

Code:

NCT06710080

Conditions

Inflammation

Community Acquired Pneumonia (CAP)

Inflammation Plaque, Atherosclerotic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Icosapent Ethyl 1000 MG Oral Capsule [Vascepa]

Placebo

Study Details

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

Conditions

Inflammation

Community Acquired Pneumonia (CAP)

Inflammation Plaque, Atherosclerotic

Study ID

NCT06710080

Start date

Apr 8, 2026

Status verified date

May, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

168 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

Participants randomized to this arm will receive Vascepa for 6 months.

placebo comparator: Placebo

Participants randomized to this arm will receive placebo for 6 months.

Interventions

Icosapent Ethyl 1000 MG Oral Capsule [Vascepa]

Participants randomized to the treatment arm will receive Vascepa 1000mg twice a day for 6 months.

Placebo

Placebo twice daily

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Locations

University of Ottawa Heart Institute

Recruiting

Ottawa, Ontario, Canada, K1Y 4W7

Contacts

More Information

Sponsor

Ottawa Heart Institute Research Corporation

Last update posted

May 11, 2026

Last verified

May, 2026

Keywords

  • Community-Acquired Infection
  • Plaque, atherosclerotic
  • Inflammation
  • Eicosapentaenoic Acid

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Heart Institute Research Corporation on 2026-05-11.