Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction (PROTECT-MI)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Myocardial Infarction; Reperfusion Injury; AMI; STEMI (ST Elevation MI)
• Intervention / Treatment: Drug: Xolatryp; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 2

Contacts and Locations

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

Study Locations

• Australia
  • New South Wales
    • Kingswood, New South Wales, Australia, 2747
      • Recruiting
      • Nepean Hospital
    • Liverpool, New South Wales, Australia, 2170
      • Not yet recruiting
      • Liverpool Hospital
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Not yet recruiting
      • Royal Adelaide Hospital
  • Victoria
    • Epping, Victoria, Australia, 3076
      • Not yet recruiting
      • Northern Health
    • Saint Albans, Victoria, Australia, 3021
      • Not yet recruiting
      • Sunshine Hospital
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Not yet recruiting
      • Sir Charles Gairdner Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Xolatryp intravenous infusion; After randomization, patients receive primary PCI and standard therapy. Patients assigned to the experimental arm also receive Xolatryp, administered as a single, continuous intravenous infusion (i.v.) for 6 hours.	Drug: Xolatryp; Patients assigned to the treatment arm recieve Xolatryp administered as a continuous intravenous (i.v) infusion for 6 hours.
Placebo Comparator: Placebo intravenous infusion; After randomization, patients receive primary PCI and standard therapy. Patients assigned to the placebo arm also recieve a placebo comparator, administered as a single, 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events	Incidence of adverse events (AE) and serious adverse events (SAE) overall. Incidence of AEs and SAEs deemed related to Xolatryp. Incidence of AEs and SAEs deemed cardiac related.	From enrollment up to and including follow-up assessments on Day 30 (end of study)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma concentration of Xolatryp during the infusion	Blood sample(s) taken at 4 hours post the start of infusion	Blood samples will be taken for pharmacokinetic (PK) assessment at 4 hours after start of infusion. Where feasible, a sample should be taken at 10 minutes into the infusion.
ST-segment elevation resolution	Comparison between treatment groups of ST-segment elevation resolution calculated from pre-PCI ECG and first post procedural ECG	pre-PCI ECG and first post procedural ECG
Cardiac Injury Biomarkers	Plasma Troponin I levels calculated as area under the curve (AUC) over 48 hours post PCI	48 hours post PCI
Incidence of Arrhythmias	Comparison of number of arrhythmias of interest recorded on telemetry (48 hours) between patients treated with Xolatryp vs Placebo. Arrhythmias of interest are sustained ventricular tachycardia (VT), non-sustained ventricular tachycardia (NSVT), and high degree- atrioventricular (AV) block.	Telemetry to 48 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac Infarct Size	Volumetric quantification comparison between treatment groups of cardiac infarct size parameters: Acute myocardial infarct size indexed to left ventricular mass, and Myocardial Salvage Index (MSI).	Day 5 (+/- 2 days)
Left Ventricular End-diastolic volume	Left Ventricular End-diastolic volume measurement from CMR will be used to assess cardiac function on Day 5 (+/- 2 days)	Day 5
Patient Reported Outcomes (PRO) Questionnaire	36-Item Short Form Health Survey (SF-36)	Day 30 (end of study)
Left Ventricular Ejection fraction	Left ventricular ejection fraction measurement from echocardiogram will be used to assess cardiac function prior to discharge and 30 days post primary PCI	Day 2 and Day 30
Left Ventricular Function	Left Ventricular Function measurement from echocardiogram will be used to assess cardiac function prior to discharge and 30 days post primary PCI	Day 2 and Day 30
Left Ventricular End-systolic Volume	Left Ventricular Volume measurement from echocardiogram will be used to assess cardiac function prior to discharge and 30 days post primary PCI	Day 2 and Day 30
Fractional shortening	Fractional shortening will be assessed via echocardiogram prior to discharge and at Day 30.	Day 2 and 30

Collaborators and Investigators

• Sponsor: Nyrada Pty Ltd

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: January 8, 2026
• First Submitted That Met QC Criteria: January 15, 2026
• First Posted (Actual): January 23, 2026

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: PCI; STEMI
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Ischemia; Pathological Conditions, Signs and Symptoms; ST Elevation Myocardial Infarction; Myocardial Infarction; Reperfusion Injury
• Other Study ID Numbers: NYR-2A-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No