What side effects are associated with this type of intervention?

Common treatments for heart attack include nitrates, which can cause headaches, dizziness, and hypotension. Interleukin-1 inhibitors like anakinra, used for coronary artery disease, may lead to injection site reactions, infections, and neutropenia. Other cardiovascular drugs, such as those affecting prostaglandin pathways or ATP-sensitive potassium channels, can have side effects like gastrointestinal issues, bleeding, and changes in blood pressure. While specific side effects of NLRP3 inflammasome inhibitors like Dapansutrile are not detailed, similar treatments often involve immune modulation, which can increase the risk of infections and inflammatory responses.

What prior FDA approvals exist?

FDA-approved treatments for heart attacks primarily include antiplatelet agents (such as aspirin and clopidogrel), anticoagulants (like heparin), thrombolytics (such as alteplase), beta-blockers, ACE inhibitors, and statins. While the NLRP3 inflammasome inhibitor dapansutrile is being studied for its potential benefits in reducing inflammation and plaque volume in heart attack patients, there are no specific FDA-approved NLRP3 inhibitors for heart attack treatment as of now. Current treatments focus on restoring blood flow, reducing clot formation, and managing risk factors.

What other types of research exist?

Promising novel alternatives to Dapansutrile for heart attack patients include other inflammasome inhibitors and anti-inflammatory agents. One potential alternative is Canakinumab, an IL-1β inhibitor, which has shown efficacy in reducing cardiovascular events in post-myocardial infarction patients. Additionally, Colchicine, an anti-inflammatory medication, has demonstrated benefits in reducing the risk of recurrent cardiovascular events. These alternatives target inflammation, a key factor in post-heart attack recovery, similar to Dapansutrile.

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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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

0 / 14Eligibility criteria met

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.