NCT05880355Not yet recruitingEarly phase 1
Multimodality Cardiovascular Imaging for the Translation of Therapies for Vascular Activation After MI
Source: ClinicalTrials.gov · Last updated 4 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 4 May 2023
- Start date
- 1 Apr 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- University of Virginia
- Diseases
- Coronary artery disease
- NCT number
- NCT05880355
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 60
- From 1 Apr 2026 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Failed primary PCI or need for emergent bypass surgery
- Recent stroke (within previous 3 months)
Other illness
- 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
- Active malignancy or recent malignancy with any systemic anti-cancer treatment
- Active infection
- Use of immunosuppressive medications or immunodeficiency disorder
- Allergy to ultrasound enhancing agents or polyethylene glycol
Lab values
- Neutropenia (ANC \<2,000)
- Moderate or severe renal impairment (GFR \<30 ml/min)
Other
- Type II MI
- Co-morbidity limiting 6 month survival
- Pregnancy or breastfeeding
Who the study is looking for
- 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
Age in the registry: 25 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.