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Inflammasome Inhibitor

Dapansutrile for Heart Attack Recovery

Phase < 1
Waitlist Available
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Carotid or femoral artery plaque at baseline, or carotid intima media thickness >1.5 mm
Reperfusion therapy planned or performed within prior 48 hrs
Must not have
Active malignancy or recent malignancy with any systemic anti-cancer treatment
Use of immunosuppressive medications or immunodeficiency disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Summary

This trial tests a pill called dapansutrile on heart attack patients who received prompt care. The pill aims to reduce inflammation, which can help lower harmful artery plaque and improve heart function.

Who is the study for?
This trial is for individuals who have had a type I heart attack and received reperfusion therapy within the last 48 hours. They must have certain levels of artery plaque or thickness to join. People with severe kidney issues, recent strokes, allergies to specific agents, pregnancy, life-threatening complications from their heart attack, certain infections or cancers can't participate.
What is being tested?
The study tests if dapansutrile (an inflammasome inhibitor) affects carotid plaque volume over six months compared to a placebo in patients after an urgent heart attack treatment. It also looks at inflammation in plaques and how well small blood vessels in the heart are working.
What are the potential side effects?
Potential side effects of dapansutrile may include allergic reactions for those sensitive to it or its class of drugs. Since this is a new area of research, participants will be closely monitored for any unexpected side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have plaque in my carotid or femoral artery, or my carotid artery wall is thick.
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I have had or am scheduled for a procedure to restore blood flow within the last 2 days.
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I have had a recent heart attack.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently receiving or recently received treatment for cancer.
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I am taking immunosuppressive drugs or have an immune deficiency.
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I currently have an infection.
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I have had a severe heart attack complication.
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My kidney function is severely reduced.
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My heart beats irregularly and treatments haven't worked.
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I am allergic to dapansutril, OLT177, or similar drugs.
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I have had a type of heart attack known as Type II MI.
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My initial heart artery opening treatment didn't work or I need urgent heart bypass surgery.
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I have severe heart failure.
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I have a health condition that may limit my life to 6 months.

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.
Primary study objectives
Remote plaque volume
Secondary study objectives
Coronary microvascular function
Plaque inflammation

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: DapansutrileExperimental Treatment1 Intervention
Subjects randomized to receive oral dapnsutrile
Group II: ControlPlacebo Group1 Intervention
Subjects randomized to receive oral placebo

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for heart attack focus on reducing inflammation, improving heart function, and preventing further damage. NLRP3 inflammasome inhibitors like dapansutrile reduce inflammation by blocking the activation of the inflammasome, which is crucial in the inflammatory response. This can help decrease the progression of atherosclerosis and stabilize plaques, reducing the risk of further cardiovascular events. Inotropic agents like milrinone and levosimendan improve heart function by increasing cardiac output and reducing infarct size, which helps the heart pump more effectively. TNF-alpha inhibitors reduce inflammation by blocking the action of tumor necrosis factor-alpha, a key cytokine in the inflammatory process, thereby lowering the risk of myocardial infarction. These mechanisms are vital for heart attack patients as they address both the immediate and long-term effects of the condition, improving survival and quality of life.
Qi Dan Li Xin pill improves chronic heart failure by regulating mTOR/p70S6k-mediated autophagy and inhibiting apoptosis.Intracoronary levosimendan prevents myocardial ischemic damages and activates survival signaling through ATP-sensitive potassium channel and nitric oxide.Anti-ischemic effects of inotropic agents in experimental right ventricular infarction.

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
775 Previous Clinical Trials
1,284,822 Total Patients Enrolled

Media Library

Dapansutrile (Inflammasome Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05880355 — Phase < 1
Heart Attack Research Study Groups: Dapansutrile, Control
Heart Attack Clinical Trial 2023: Dapansutrile Highlights & Side Effects. Trial Name: NCT05880355 — Phase < 1
Dapansutrile (Inflammasome Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05880355 — Phase < 1
~40 spots leftby Dec 2027