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Xolatryp in STEMI Patients Undergoing Primary PCI
NCT07362446Phase 2
Key facts
- Status
- Recruiting
- Start
- Jul 2026
- Primary completion
- Jun 2027
- Countries
- 1
- Sponsor
- Nyrada Inc
- Modality
- Small Molecules
- Drugs
- Xolatryp
- Conditions
- ST elevation myocardial infarction (STEMI)reperfusion injury (IRI)
01
Overview
Phase 2, randomised, double-blind trial in ST elevation myocardial infarction (STEMI) and reperfusion injury (IRI) comparing Xolatryp intravenous infusion with Placebo intravenous infusion (2 arms). Primary endpoint: Incidence of Adverse Events at 30 days. Started Jul 2026; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Xolatryp intravenous infusion
Patients receive primary PCI and standard therapy, plus Xolatryp administered as a single, continuous intravenous infusion for 6 hours.
Placebo intravenous infusion
Patients receive primary PCI and standard therapy, plus placebo administered as a single, continuous intravenous infusion for 6 hours.
03
Who it enrols
Adults aged 40-75 with first-time STEMI undergoing primary PCI within 6 hours of symptom onset, hemodynamically stable, without prior MI, cardiomyopathy, or severe renal impairment.
04
Endpoints
Primary
Incidence of Adverse Events
Secondary
Plasma concentration of Xolatryp
ST-segment elevation resolution
Cardiac Injury Biomarkers
Incidence of Arrhythmias
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