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

NCT05880355 | Not Yet Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: HSR230183
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Remote plaque volume

  Carotid artery plaque volume change by ultrasound measured by 3D ultrasound. Outcome units will be cm3 averaged for bilateral carotid arteries.

  6 months

Secondary Outcomes (2)

• Plaque inflammation

  3 months

• Coronary microvascular function

  3 months

Study Arms (2)

Dapansutrile

EXPERIMENTAL

Subjects randomized to receive oral dapnsutrile

Drug: Dapansutrile

Control

PLACEBO COMPARATOR

Subjects randomized to receive oral placebo

Other: Placebo

Interventions

Dapansutrile DRUG

Oral inhibitor of NLRP3

Dapansutrile

Placebo OTHER

Non-active placebo

Control

Eligibility Criteria

• Age: 25 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Myocardial Infarction

Interventions

dapansutrile

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Central Study Contacts

Jonathan R Lindner, MD

CONTACT

4342979442; jlindner@virginia.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Vice Chief for Research, Cardiovascular Division

Model Details: Randomized, single blind study.

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 30, 2023
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): January 30, 2029
• Last Updated: June 4, 2025

Record last verified: 2025-05

Locations

US (1)