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

NCT ID: NCT05880355

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-04-01
• Study Completion Date: 2029-01-30

Brief 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.

Conditions

Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Dapansutrile

Subjects randomized to receive oral dapnsutrile

Group Type: EXPERIMENTAL

Dapansutrile

Intervention Type: DRUG

Oral inhibitor of NLRP3

Control

Subjects randomized to receive oral placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Non-active placebo

Interventions

Dapansutrile

Oral inhibitor of NLRP3

Intervention Type: DRUG

Placebo

Non-active placebo

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Lindner, MD

Professor of Medicine, Vice Chief for Research, Cardiovascular Division

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Virginia

Charlottesville, Virginia, United States

Countries

United States

Central Contacts

Jonathan R Lindner, MD

Role: CONTACT

jlindner@virginia.edu

4342979442

Other Identifiers

HSR230183

Identifier Type: -

Identifier Source: org_study_id