Vascepa for Community-Acquired Pneumonia
(TIN-CAP Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Ottawa Heart Institute Research Corporation
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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
This trial is for adults with Community-Acquired Pneumonia (CAP) who are interested in testing a treatment aimed at reducing artery inflammation. Specific eligibility details aren't provided, but typically participants must meet certain health criteria and not have conditions that could interfere with the study or their safety.Inclusion Criteria
I am over 18 years old.
I was hospitalized for pneumonia, confirmed by chest imaging and symptoms like fever and cough.
Patients who have given informed consent
Exclusion Criteria
Patients with dye allergy will not undergo CTA but will have PET/CT
Pregnant patients (all women of childbearing potential will have a negative BHCG test)
I have an active inflammatory condition or am on systemic anti-inflammatory therapy.
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Treatment Details
Interventions
- Icosapent Ethyl (Anti-inflammatory)
- Placebo (Medication)
Trial OverviewThe trial is testing Icosapent Ethyl (Vascepa), comparing it to a placebo to see if it can reduce arterial inflammation in CAP patients. Participants will take either Vascepa or the placebo twice daily for six months and attend three clinic visits for evaluation.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TreatmentExperimental Treatment1 Intervention
Participants randomized to this arm will receive Vascepa for 6 months.
Group II: PlaceboPlacebo Group1 Intervention
Participants randomized to this arm will receive placebo for 6 months.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Ottawa Heart InstituteOttawa, Canada
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Who Is Running the Clinical Trial?
Ottawa Heart Institute Research CorporationLead Sponsor