Preventing reperfusion injury during ST-elevation heart attack using Xolatryp

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Nepean Hospital
  Kingswood, New South Wales, Australia Recruiting
• Liverpool Hospital
  Liverpool, New South Wales, Australia Recruiting
• Northern Health
  Epping, Victoria, Australia Recruiting
• Sir Charles Gairdner Hospital
  Nedlands, Western Australia, Australia Recruiting
• Royal Perth Hospital
  Perth, Western Australia, Australia Recruiting
• Royal Adelaide Hospital
  Adelaide, South Australia, Australia Not yet recruiting

Study contacts

• Study coordinator: Alexandra Suchowerska Director, Clinical Operations and Regulatory Affairs, PhD
• Email: Protect-MI@Nyrada.com
• Phone: +61 294-983-390

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.