Myocardial InfarctionEarly Phase 1NCT05880355
Multimodality Cardiovascular Imaging for the Translation of Therapies for Vascular Activation After MI
A Early Phase 1 study testing Dapansutrile in people with Myocardial Infarction, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 99 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Dapansutrile
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to 30 Jan 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
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
- Being tested
- Dapansutrile, Placebo
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapansutrileDrug
Oral inhibitor of NLRP3
PlaceboOther
Non-active placebo
| Study group | Role | What they receive |
|---|---|---|
| Dapansutrile | Experimental | Subjects randomized to receive oral dapnsutrile Receives: Drug: Dapansutrile |
| Control | Placebo comparator | Subjects randomized to receive oral placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remote plaque volume
Carotid artery plaque volume change by ultrasound measured by 3D ultrasound. Outcome units will be cm3 averaged for bilateral carotid arteries.
Measured: 6 months
Secondary outcomes (2)
Plaque inflammation
Carotid artery plaque inflammatory activity by PET-CT. Units will be SVU averaged bilaterally for a region-of-interest over the carotid bifurcation.
Measured: 3 months
Coronary microvascular function
Coronary microvascular reactivity by myocardial contrast echo (MCE) quantitative perfusion imaging. The primary endpoint unit will be coronary microvascular flux rate reserve (regadenoson stress: rest ratio).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start1 Apr 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, single blind study.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Lindner, MD, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05880355
- Sponsor's protocol ID
- HSR230183
- Status last verified
- May 2025
- First submitted
- 4 May 2023
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodality Cardiovascular Imaging for the Translation of Therapies for Vascular Activation After MI
- ClinicalTrials.gov ID
- NCT05880355
- Acronym / sponsor ID
- HSR230183
- Conditions
- Myocardial Infarction
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Jan 2029 (estimated)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, single blind study.
| Arm | Type | Receives |
|---|---|---|
| Dapansutrile | Experimental | Drug: DapansutrileSubjects randomized to receive oral dapnsutrile |
| Control | Placebo comparator | Other: PlaceboSubjects randomized to receive oral placebo |
Who may qualify
- Ages
- 25 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DapansutrileOral inhibitor of NLRP3 | Drug | Dapansutrile |
| PlaceboNon-active placebo | Other | Control |
Primary outcome
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.
2 secondary outcomes
Plaque inflammation
Time frame: 3 months
Coronary microvascular function
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Dapansutrile in people with Myocardial Infarction, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan R Lindner, MD (4342979442, jlindner@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remote plaque volume (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.