Clinical Trial

Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction

Study acronym: PROTECT-MI
Recruiting Phase 2
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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.
Protocol Amendment History 2 changes
critical Recruitment opened 2026-04-25
notable Primary completion pushed: 2027-04-30 -> 2027-06-30 2026-04-25
Trial Details
NCT Number NCT07362446
Lead Sponsor Nyrada Pty Ltd
Conditions Myocardial Infarction, Reperfusion Injury, AMI, STEMI (ST Elevation MI)
Enrollment 300 participants
Start Date 2026-07-02
Primary Completion 2027-06-30 (estimated)
Study Completion 2027-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-09