Preventing reperfusion injury during ST-elevation heart attack using Xolatryp

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

This will test whether a single 6-hour IV infusion of Xolatryp given during primary PCI helps people having their first ST-elevation heart attack reduce heart muscle damage and improve short-term heart function.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 40 Years to 75 Years
• Sex: All
• Sponsor: Nyrada Pty Ltd (Industry-sponsored)
• Locations: 6 sites (Kingswood, New South Wales and 5 other locations)
• Trial ID: NCT07362446 on ClinicalTrials.gov

What this trial studies

Adults with a first-time STEMI who are scheduled for primary PCI within 6 hours of symptom onset are randomly assigned to a single 6-hour intravenous infusion of Xolatryp or a matching placebo. Cardiac injury and recovery are measured using blood biomarkers, ECG, echocardiography and cardiac MRI, with telephone follow-up and a clinic visit at 30 days. The trial enrolls hemodynamically stable patients (Killip class I–II, adequate oxygenation) and excludes those with prior MI or cardiomyopathy. Outcomes will compare infarct size and functional cardiac measures between the Xolatryp and placebo groups.

Who should consider this trial

Good fit: Ideal candidates are adults with a first-time STEMI presenting within 6 hours who are stable enough for primary PCI (Killip I–II, SBP ≥90 mmHg), meet the trial's age ranges, and are not pregnant or at risk of pregnancy.

Not a fit: Patients with prior myocardial infarction or cardiomyopathy, unstable hemodynamics, late presentation beyond the treatment window, or who are pregnant are unlikely to receive benefit from this intervention.

Why it matters

Potential benefit: If successful, Xolatryp could reduce infarct size and short-term cardiac dysfunction after reperfusion, potentially lowering the risk of heart failure and other complications.

How similar studies have performed: Previous pharmacologic attempts to limit reperfusion injury have shown mixed or largely disappointing results, so this specific approach remains relatively unproven.

Eligibility criteria

Inclusion Criteria:

* Have provided informed consent.
* Male patients aged 40 to 75 years of age.- Female patients aged 55 to 75 years of age, or women aged 40 to 55 years that have no possibility of being pregnant.
* Patient presents with first-time STEMI, scheduled to undergo primary PCI within 6 h of symptom onset and anticipated door to balloon time \< 2 h.
* In combination with symptoms consistent with acute MI, patient must demonstrate ST-elevation at the J-point in two contiguous leads.
* Hemodynamically stable including: systolic BP ≥ 90 mmHg, HR 50-120 bpm.
* Killip Class I or II.
* Oxygen saturation ≥ 92% on room air or low-flow oxygen.
* No ongoing VT/VF at enrolment.
* Male participants with female partners of child-bearing potential must be ready and able to use highly effective methods of birth control for at least 7 days following IP administration.

Exclusion Criteria:

* History or ECG evidence of myocardial infarction or cardiomyopathy.
* Prior major cardiac surgery, including but not limited to coronary artery bypass graft surgery (CABG).
* Known contraindication to CMR (e.g. pacemakers, cochlear implants, aneurism clips, claustrophobia, allergy to contrast medium).
* History of clinically significant renal impairment requiring dialysis or an estimated glomerular filtration rate \<30 mL/min.
* Estimated or known body weight \< 50 kg, \> 120 kg at screening.
* Concurrent enrolment in another investigational device or drug trial, or less than 30 days or 5 half-lives of investigational device or drug (whichever is longer), since ending another investigational device or drug trial(s) or receiving other investigational treatment(s). Patients who are participating in non-interventional, purely observational trials can be included.
* Life expectancy of less than 1 year due to non-cardiac pathology in the opinion of the Investigator.
* Any condition or significant clinical abnormality identified at the time of screening that in the judgment of the Investigator or any sub-Investigator would preclude safe completion of the study.
* Known history of hypersensitivity to the investigational drug, or excipients, or do not want to be exposed to soy or egg (including products and derivatives).

Where this trial is running

Kingswood, New South Wales and 5 other locations

• Nepean Hospital — Kingswood, New South Wales, Australia (Recruiting)
• Liverpool Hospital — Liverpool, New South Wales, Australia (Not_yet_recruiting)
• Royal Adelaide Hospital — Adelaide, South Australia, Australia (Not_yet_recruiting)
• Northern Health — Epping, Victoria, Australia (Not_yet_recruiting)
• Sunshine Hospital — Saint Albans, Victoria, Australia (Not_yet_recruiting)
• Sir Charles Gairdner Hospital — Nedlands, Western Australia, Australia (Not_yet_recruiting)

Study contacts

• Study coordinator: Alexandra Suchowerska Director, Clinical Operations and Regulatory Affairs, PhD

Conditions Myocardial Infarction; Reperfusion Injury; AMI; STEMI; PCI