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Anti-inflammatory

Vascepa for Community-Acquired Pneumonia (TIN-CAP Trial)

Phase 3
Waitlist Available
Research Sponsored by Ottawa Heart Institute Research Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients aged over 18 years
Patients who have hospitalization with CAP (defined as pulmonary infiltration using chest imaging, in addition to other clinical symptoms including fever, cough, and sputum)
Must not have
Patients unable to give informed consent
Patients with active inflammatory conditions (e.g. rheumatoid arthritis, chronic inflammatory bowel disease, SLE, systemic anti-inflammatory therapy (e.g. prednisone, methotrexate))
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Pivotal Trial

Summary

This trial aims to see if a medication called Vascepa can reduce inflammation in the arteries of adults with Community-Acquired Pneumonia (CAP). Participants will either take Vascepa or

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
While specific side effects of Vascepa are not listed here, common ones may include joint pain, sore throat, and irregular heartbeats among others. Placebos generally do not cause side effects as they contain no active drug.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 18 years old.
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I was hospitalized for pneumonia, confirmed by chest imaging and symptoms like fever and cough.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am unable to understand and give consent for treatment.
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I have an active inflammatory condition or am on systemic anti-inflammatory therapy.
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I agree to use two forms of contraception if I can have children.
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My kidney function, measured by GFR, is below 50 ml/min/1.72m2.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
The change in inflammation, measured on FDG PET, in the pulmonary tissue.

Side effects data

From 2018 Phase 3 trial • 8179 Patients • NCT01492361
9%
Diarrhoea
8%
Hypertension
8%
Nasopharyngitis
8%
Upper respiratory tract infection
8%
Back pain
8%
Arthralgia
7%
Bronchitis
6%
Cough
6%
Cataract
6%
Influenza
6%
Dizziness
6%
Dyspnoea
6%
Fatigue
6%
Urinary tract infection
6%
Oedema peripheral
6%
Chest pain
6%
Pain in extremity
5%
Constipation
4%
Anaemia
3%
Pneumonia
2%
Osteoarthritis
1%
Syncope
1%
Atrial fibrillation
1%
Gastrointestinal haemorrhage
1%
Non-cardiac chest pain
1%
Cellulitis
1%
Prostate cancer
1%
Angina pectoris
1%
Angina unstable
1%
Chronic obstructive pulmonary disease
1%
Sepsis
1%
Acute kidney injury
100%
80%
60%
40%
20%
0%
Study treatment Arm
AMR101
Placebo

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Icosapent Ethyl 1000 MG Oral Capsule [Vascepa]
2020
Completed Phase 4
~70

Find a Location

Who is running the clinical trial?

Ottawa Heart Institute Research CorporationLead Sponsor
196 Previous Clinical Trials
93,500 Total Patients Enrolled
5 Trials studying Inflammation
263 Patients Enrolled for Inflammation
~112 spots leftby Dec 2026
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