Multimodality Cardiovascular Imaging for the Translation of Therapies for Vascular Activation After MI
Overview
- Phase
- Early Phase 1
- Intervention
- Dapansutrile
- Conditions
- Myocardial Infarction
- Sponsor
- University of Virginia
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Remote plaque volume
- Status
- Not yet recruiting
- Last Updated
- 11 months ago
Overview
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.
Investigators
Jonathan Lindner, MD
Professor of Medicine, Vice Chief for Research, Cardiovascular Division
University of Virginia
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
Arms & Interventions
Dapansutrile
Subjects randomized to receive oral dapnsutrile
Intervention: Dapansutrile
Control
Subjects randomized to receive oral placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Remote plaque volume
Time Frame: 6 months
Carotid artery plaque volume change by ultrasound measured by 3D ultrasound. Outcome units will be cm3 averaged for bilateral carotid arteries.
Secondary Outcomes
- Plaque inflammation(3 months)
- Coronary microvascular function(3 months)