PROTECT-MI – Preventing Reperfusion Injury After Heart Attack

PROTECT-MI (Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction) is a Phase IIa, randomised, double-blind, placebo-controlled study evaluating the safety, tolerability and preliminary efficacy of Xolatryp (NCT07362446) in patients presenting with STEMI and undergoing primary PCI.

ST-segment elevation myocardial infarction (STEMI) is routinely treated with primary percutaneous coronary intervention (PCI), which mechanically reopens the blocked artery using balloon angioplasty and stenting. However, this reperfusion itself paradoxically causes further damage to heart muscle cells that survived the initial ischaemic event — a phenomenon known as ischaemia reperfusion injury (IRI), driven in part by a rapid, pathological rise in calcium ions within the cell at the moment blood flow is restored. Xolatryp™ is a small molecule inhibitor of the TRPC3/6/7 channels that mediate this calcium influx, and has already been shown to be safe and well tolerated in healthy volunteers. The trial will test whether adding a 6-hour intravenous infusion of Xolatryp to standard care can protect heart muscle from reperfusion injury in STEMI patients undergoing primary PCI.

Participants are randomised 1:1 to receive either Xolatryp (3 mg/kg over approximately six hours) or placebo as a single continuous intravenous infusion, in addition to primary PCI and standard-of-care treatment. Cardiac imaging is an important component of the study: participants undergo cardiac magnetic resonance (CMR) and echocardiography, alongside ECG and cardiac biomarker assessments, with CMR-derived infarct size and myocardial salvage serving as key efficacy measures alongside troponin release, ST-segment resolution and arrhythmia incidence.

The trial will enrol approximately 300 patients across multiple centres, with each participant followed for 30 days post-infusion. It is sponsored by Nyrada Pty Ltd.