Multimodality Cardiovascular Imaging for the Translation of Therapies for Vascular Activation After MI

University of Virginia

Status and phase: Begins enrollment in 1 month; Early Phase 1

Conditions: Myocardial Infarction

Treatments: Drug: Dapansutrile; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05880355

HSR230183

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 25 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Dapansutrile

Experimental group

Description:

Subjects randomized to receive oral dapnsutrile

Treatment:

Drug: Dapansutrile

Control

Placebo Comparator group

Description:

Subjects randomized to receive oral placebo

Treatment:

Other: Placebo