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Not yet recruiting NCT05880355

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

Early Phase I Interventional Myocardial Infarction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dapansutrile, Placebo.
Who it may be relevant to
Registry conditions: Myocardial Infarction. Basic parameters: 25 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug Dapansutrile
    Oral inhibitor of NLRP3
  • Other Placebo
    Non-active placebo

Primary outcome measures

  • Remote plaque volume [Time frame: 6 months]
Secondary outcome measures (2)
  • Plaque inflammation [Time frame: 3 months]
  • Coronary microvascular function [Time frame: 3 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Virginia — Charlottesville

Identifiers

NCT: NCT05880355 · HSR230183

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗