A Phase 2 interventional study of Xolatryp and Placebo in Myocardial Infarction, Reperfusion Injury and AMI, sponsored by Nyrada Pty Ltd. Recruiting at 8 sites in Australia. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Nyrada Pty Ltd · Phase 2, Interventional, and Treatment
This study is open to adults with ST elevation myocardial infarction (heart attack) undergoing primary percutaneous coronary intervention (PCI). The purpose of this study is to determine whether a medicine called Xolatryp is safe and effective in improving cardiac outcomes. One dose of Xolatryp will be tested in this study.
Participants are put into two groups randomly, which means by chance. One group receives a single 6-hour continuous intravenous infusion of Xolatryp and one group receives placebo. Participants are in the study for about 30 days.
Placebo infusion looks like Xolatryp but do not contain any medicine. Participants are followed up via telephone and there is one visit to the study site on day 30.
Heart health is assessed based on the analysis of blood samples, which are collected at the study site, via electrocardiogram (ECG), echocardiogram and cardiac magnetic resonance (CMR) imaging. At the end of the study, the results are compared between the two groups. During the study, the doctors also regularly check the general health of the participants.
Exclusion Criteria:
After randomization, patients receive primary PCI and standard therapy. Patients assigned to the experimental arm also receive Xolatryp, administered as a single, continuous intravenous infusion (i.v.) for 6 hours.
Drug: Xolatryp
After randomization, patients receive primary PCI and standard therapy. Patients assigned to the placebo arm also recieve a placebo comparator, administered as a single, continuous intravenous (i.v.) infusion for 6 hours.
Drug: Placebo
Patients assigned to the treatment arm recieve Xolatryp administered as a continuous intravenous (i.v) infusion for 6 hours.
Patients assigned to the placebo comparator arm receive 0.1% of 20% Intralipid in 0.9% normal saline, administered via continuous intravenous (i.v.) infusion for 6 hours.
Incidence of Adverse Events
Incidence of adverse events (AE) and serious adverse events (SAE) overall. Incidence of AEs and SAEs deemed related to Xolatryp. Incidence of AEs and SAEs deemed cardiac related.
Time frame: From enrollment up to and including follow-up assessments on Day 30 (end of study)
Plasma concentration of Xolatryp during the infusion
Blood sample(s) taken at 4 hours post the start of infusion
Time frame: Blood samples will be taken for pharmacokinetic (PK) assessment at 4 hours after start of infusion. Where feasible, a sample should be taken at 10 minutes into the infusion.
ST-segment elevation resolution
Comparison between treatment groups of ST-segment elevation resolution calculated from pre-PCI ECG and first post procedural ECG
Time frame: pre-PCI ECG and first post procedural ECG
Cardiac Injury Biomarkers
Plasma Troponin I levels calculated as area under the curve (AUC) over 48 hours post PCI
Time frame: 48 hours post PCI
Incidence of Arrhythmias
Comparison of number of arrhythmias of interest recorded on telemetry (48 hours) between patients treated with Xolatryp vs Placebo. Arrhythmias of interest are sustained ventricular tachycardia (VT), non-sustained ventricular tachycardia (NSVT), and high degree- atrioventricular (AV) block.
Time frame: Telemetry to 48 hours
Cardiac Infarct Size
Volumetric quantification comparison between treatment groups of cardiac infarct size parameters: Acute myocardial infarct size indexed to left ventricular mass, and Myocardial Salvage Index (MSI).
Time frame: Day 5 (+/- 2 days)
Left Ventricular End-diastolic volume
Left Ventricular End-diastolic volume measurement from CMR will be used to assess cardiac function on Day 5 (+/- 2 days)
Time frame: Day 5
Patient Reported Outcomes (PRO) Questionnaire
36-Item Short Form Health Survey (SF-36)
Time frame: Day 30 (end of study)
Left Ventricular Ejection fraction
Left ventricular ejection fraction measurement from echocardiogram will be used to assess cardiac function prior to discharge and 30 days post primary PCI
Time frame: Day 2 and Day 30
Left Ventricular End-systolic Volume
Left Ventricular Volume measurement from echocardiogram will be used to assess cardiac function prior to discharge and 30 days post primary PCI
Time frame: Day 2 and Day 30
Left Ventricular Function
Left Ventricular Function measurement from echocardiogram will be used to assess cardiac function prior to discharge and 30 days post primary PCI
Time frame: Day 2 and Day 30
Fractional shortening
Fractional shortening will be assessed via echocardiogram prior to discharge and at Day 30.
Time frame: Day 2 and 30
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Nyrada Pty Ltd