Targeting Vascular INflammation in Patients with Community-Acquired Pneumonia

NCT ID: NCT06710080

Last Updated: 2024-12-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-15
• Study Completion Date: 2027-06-30

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

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:

1. measure the effect of icosapent ethyl vs. placebo on reducing arterial inflammation over a 6-month treatment period, with primary analysis at 6-months;

2. the correlation between imaging and blood biomarkers over time relative to the drug response.

Conditions

Inflammation; Community Acquired Pneumonia (CAP); Inflammation Plaque, Atherosclerotic

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment

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

Group Type: EXPERIMENTAL

Icosapent Ethyl 1000 MG Oral Capsule [Vascepa]

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo twice daily

Interventions

Icosapent Ethyl 1000 MG Oral Capsule [Vascepa]

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

Intervention Type: DRUG

Placebo

Placebo twice daily

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Heart Institute Research Corporation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Countries

Canada

Central Contacts

Kevin Boczar, MD

Role: CONTACT

Phone: 1-613-696-7000

Email: kboczar@ottawaheart.ca

Poppy MacPhee, BScN

Role: CONTACT

Phone: 1-613-696-7000

Email: pmacphee@ottawaheart.ca

Facility Contacts

Kevin Boczar

Role: primary

Poppy MacPhee

Role: backup

Other Identifiers

2023

Identifier Type: -

Identifier Source: org_study_id