Advanced Cardiovascular Imaging of the Systemic Effects of Inflammasome Activation

• Status: Not yet recruiting
• Trial end date: 2028-10-30
• Target enrollment: 0
• Participant gender: All

Summary

Subjects with urgently reperfused type I myocardial infarction (MI) will be recruited and randomized to receive either placebo or the oral inflammasome (NLRP3) inhibitor dapansutrile. The primarily outcome measure will be carotid plaque volume change over 6 months; secondary outcome measures will be plaque inflammatory activity and coronary microvascular function.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Virginia
• Treatments: Dapansutrile

Criteria

Inclusion Criteria:

• Acute type I myocardial infarction (NSTEMI or STEMI)

• Reperfusion therapy planned or performed within prior 48 hrs

• Carotid or femoral artery plaque at baseline, or carotid intima media thickness >1.5 mm

Exclusion Criteria:

• Type II MI

• Failed primary PCI or need for emergent bypass surgery

• Severe heart failure (NYHA class IV)

• Life-threatening complication of MI (myocardial rupture, ischemic VSD, papillary muscle rupture)

• Refractory ventricular arrhythmias

• Allergy to dapansutril, OLT177, or drugs in the same class

• Co-morbidity limiting 6 month survival

• Active malignancy or recent malignancy with any systemic anti-cancer treatment

• Active infection

• Use of immunosuppressive medications or immunodeficiency disorder

• Neutropenia (ANC <2,000)

• Moderate or severe renal impairment (GFR <30 ml/min)

• Recent stroke (within previous 3 months)

• Allergy to ultrasound enhancing agents or polyethylene glycol

• Pregnancy or breastfeeding