NCT07362446

Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction

A Randomised, Double-Blind, Placebo-Controlled, Study of Xolatryp in Patients Presenting With STEMI Undergoing Primary PCI

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Nyrada Pty Ltd · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Myocardial Infarction
• Reperfusion Injury
• AMI
• STEMI (ST Elevation MI)

Interventions

Type	Name	Description
DRUG	Xolatryp	Patients assigned to the treatment arm recieve Xolatryp administered as a continuous intravenous (i.v) infusion for 6 hours.
DRUG	Placebo	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.

Timeline

• Start date: 2026-04-16
• Primary completion: 2027-04-30
• Completion: 2027-09-30
• First posted: 2026-01-23
• Last updated: 2026-03-24

Locations

5 sites across 1 country: Australia