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Recruiting NCT06710080

Targeting Vascular INflammation in Patients With Community-Acquired Pneumonia

Phase III Interventional Inflammation Community Acquired Pneumonia (CAP) Inflammation Plaque, Atherosclerotic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Icosapent Ethyl 1000 MG Oral Capsule [Vascepa], Placebo.
Who it may be relevant to
Registry conditions: Inflammation, Community Acquired Pneumonia (CAP), Inflammation Plaque, Atherosclerotic. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Icosapent Ethyl 1000 MG Oral Capsule [Vascepa]
    Participants randomized to the treatment arm will receive Vascepa 1000mg twice a day for 6 months.
  • Drug Placebo
    Placebo twice daily

Primary outcome measures

  • 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]
Secondary outcome measures (1)
  • The change in inflammation, measured on FDG PET, in the pulmonary tissue. [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

Patients who have:

  • Hospitalization with CAP (defined as pulmonary infiltration using chest imaging, in addition to other clinical symptoms including fever, cough, and sputum)
  • age > 18 years;
  • given informed consent.

Exclusion criteria

Patients who have:

  • 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).
  • active inflammatory conditions (e.g. rheumatoid arthritis, chronic inflammatory bowel disease, SLE, systemic anti-inflammatory therapy (e.g. prednisone, methotrexate));
  • pregnancy (all women of child bearing potential will have a negative BHCG test;
  • breastfeeding;
  • 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.
  • Allergies to icosapent ethyl
  • allergies to fish or shellfish
  • glomerular filtration rate (GFR) <50 ml/min/1.72m2 (excluded from CTA portion)
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • University of Ottawa Heart Institute — Ottawa

Publications

  • Stotts C, Corrales-Medina VF, deKemp RA, Wells GA, Beanlands R, Raggi P, Ferrara G, Sligl W, A Connelly K, Paul N, Brouwers M, Contreras-Dominguez V, Yadav K, Torres C, Tavoosi A, Wiefels C, Kirpalani A, Romsa JG, Grey B, Deva D, Rayner K, Boczar KE. Targeting Vascular Inflammation In Patients with Community-Acquired Pneumonia (TIN-CAP): protocol for a multicentre, randomised, double-blind, placeb PMID 41781043

Identifiers

NCT: NCT06710080 · 2023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗