Vascepa for Community-Acquired Pneumonia

(TIN-CAP Trial)

Overseen By Poppy MacPhee, BScN

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Ottawa Heart Institute Research Corporation

Must not be taking: Prednisone, Methotrexate

Disqualifiers: Cancer, Inflammatory conditions, Pregnancy, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Vascepa (Icosapent Ethyl), a medication, can reduce inflammation in the arteries of adults with community-acquired pneumonia (a lung infection). Researchers aim to determine if Vascepa is more effective at reducing inflammation than a placebo, which contains no active ingredients. Participants will take either Vascepa or the placebo twice daily for six months and attend three clinic visits for checkups. This trial may suit adults hospitalized with community-acquired pneumonia who experience symptoms like fever and cough. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on systemic anti-inflammatory therapy (like prednisone or methotrexate), you may not be eligible to participate.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that icosapent ethyl, also known as Vascepa, is generally safe for people. Studies have found it to be well-tolerated, even for conditions like heart disease. For instance, one study found it reduced heart-related problems without major safety issues. Another study with COVID-19 pneumonia patients showed that icosapent ethyl was safely used as part of their treatment.

While these findings suggest the treatment is safe, participants should discuss any potential risks with their doctor. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for pneumonia?

Unlike standard treatments for community-acquired pneumonia, which typically involve antibiotics and supportive care, Vascepa (Icosapent Ethyl) offers a novel approach by using a purified omega-3 fatty acid. Researchers are excited because it potentially reduces inflammation and improves immune response, offering a different mechanism of action compared to traditional antibiotics. This could be especially beneficial for patients who need alternative or additional support beyond what antibiotics can provide.

What evidence suggests that Vascepa might be an effective treatment for Community-Acquired Pneumonia?

Research has shown that icosapent ethyl, also known as Vascepa, can help reduce inflammation, which is important in conditions like community-acquired pneumonia (CAP). One study demonstrated that patients with inflammation-related conditions experienced a noticeable decrease in inflammation markers after taking Vascepa. Specifically, levels of markers like creatinine and CRP decreased, indicating improvement. Additionally, Vascepa has been shown to lower the risk of heart problems, suggesting wider anti-inflammatory benefits. In this trial, participants will receive either Vascepa or a placebo for 6 months to evaluate its potential to reduce inflammation in patients with CAP. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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)

Breastfeeding patients

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take Vascepa or a placebo twice a day for 6 months

6 months

3 visits (in-person at baseline, 30 days, and 6 months)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Icosapent Ethyl
• Placebo

Trial Overview

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.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Ottawa Heart Institute Research Corporation

Lead Sponsor

Trials

200

Recruited

95,800+

Citations

1.

clinconnect.io

clinconnect.io/trials/NCT06710080

Targeting Vascular INflammation in Patients with - ClinConnect

This clinical trial is studying whether a medication called icosapent ethyl, also known as Vascepa, can help reduce inflammation in adults with Community- ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7751801/

Three Cases of COVID-19 Pneumonia That Responded to ...

With icosapent ethyl and antibiotics alone, the 75-year-old patient improved remarkably, quantitively assessed by a reduction in his creatinine and CRP, with ...

3.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa1812792

Cardiovascular Risk Reduction with Icosapent Ethyl for ...

Among these results, the rates of adjudicated sudden cardiac death were 1.5% in the icosapent ethyl group and 2.1% in the placebo group (hazard ...

4.

biospace.com

biospace.com/vascepa-icosapent-ethyl-26-percent-reduction-in-key-secondary-composite-endpoint-of-cardiovascular-death-heart-attacks-and-stroke-demonstrated-in-reduce-it-supports-25-percent-overall-reduction-in-five-point-major-adverse-cardiovascular-event

Vascepa® (icosapent ethyl) 26% Reduction in Key ...

REDUCE-IT primary results confirmed 25% relative risk reduction (RRR) for the topline primary endpoint result with multiple robust demonstrations of efficacy.

5.

vascepahcp.com

vascepahcp.com/outcomes-data/

CV Outcomes-The Data - VASCEPA® (icosapent ethyl)

Primary endpoint by achieved triglyceride level at 1 year · Median percent change in TG for VASCEPA 4 g/d compared to placebo was -19.7%. · VASCEPA has multiple ...

6.

ema.europa.eu

ema.europa.eu/en/documents/assessment-report/vazkepa-epar-public-assessment-report_en.pdf

Vazkepa , INN-icosapent ethyl - European Medicines Agency

safe and well-tolerated from its use as laxative. However, it is difficult to exclude any increased CV risk based on standard safety data.

7.

multivu.com

multivu.com/players/English/8431651-amarin-reduce-it-study-vascepa/

Vascepa® (icosapent ethyl) 26% Reduction in ... - MultiVu

Cardiovascular Death Reduced by 20% Fatal or Nonfatal Heart Attacks Reduced by 31% Fatal or Nonfatal Stroke Reduced by 28%