Dapansutrile for Heart Attack Recovery

Overseen By Jonathan R Lindner, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Virginia

Must not be taking: Immunosuppressives

Disqualifiers: Type II MI, Severe heart failure, Active malignancy, others

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are using immunosuppressive medications, you may not be eligible to participate.

How is the drug Dapansutrile unique for heart attack recovery?

Dapansutrile is unique because it targets inflammation, which is a key factor in heart attack recovery, by inhibiting a specific protein involved in the inflammatory process. This approach is different from traditional treatments that primarily focus on improving blood flow or reducing heart workload. ^{1 2 3 4 5}

Eligibility Criteria

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.

Inclusion Criteria

I have plaque in my carotid or femoral artery, or my carotid artery wall is thick.

I have had or am scheduled for a procedure to restore blood flow within the last 2 days.

I have had a recent heart attack.

Exclusion Criteria

Pregnancy or breastfeeding

I am currently receiving or recently received treatment for cancer.

I am taking immunosuppressive drugs or have an immune deficiency.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either placebo or the oral inflammasome (NLRP3) inhibitor dapansutrile

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• Dapansutrile
• Placebo

Trial Overview 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.

Participant Groups

Group I: Dapansutrile Experimental Treatment 1 Intervention

Subjects randomized to receive oral dapnsutrile

Group II: Control Placebo Group 1 Intervention

Subjects randomized to receive oral placebo

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

References

1. China pubmed.ncbi.nlm.nih.gov

Protective Effects of Danlou Tablet () against Murine Myocardial Ischemia and Reperfusion Injury In Vivo. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy of a new transdermal nitroglycerin patch (Deponit 10) for stable angina pectoris. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

[Results of a trial of a coronary therapeutic agent, Adalat (author's transl)]. [2013]

4. China pubmed.ncbi.nlm.nih.gov

Guanxin Danshen Dripping Pills Improve Quality of Life and Cardiovascular Prognoses of CHD Patients after PCI with Anxiety or Depression (GLAD Study): A Randomized Double-Blind Placebo-Controlled Study. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Usefulness of PY 108-068, a new calcium channel blocker, for angina pectoris. [2019]