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NCT Number: NCT07362446

Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction

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.

Recruiting

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nepean Hospital, Kingswood, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Xolatryp

Drug

Patients assigned to the treatment arm recieve Xolatryp administered as a continuous intravenous (i.v) infusion for 6 hours.

Placebo

Drug

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.

Primary outcomes

  1. Incidence of Adverse Events

    Time frame: From enrollment up to and including follow-up assessments on Day 30 (end of study)

    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.

Secondary outcomes

  1. Plasma concentration of Xolatryp during the infusion

    Time frame: 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.

    Blood sample(s) taken at 4 hours post the start of infusion

  2. ST-segment elevation resolution

    Time frame: pre-PCI ECG and first post procedural ECG

    Comparison between treatment groups of ST-segment elevation resolution calculated from pre-PCI ECG and first post procedural ECG

  3. Cardiac Injury Biomarkers

    Time frame: 48 hours post PCI

    Plasma Troponin I levels calculated as area under the curve (AUC) over 48 hours post PCI

  4. Incidence of Arrhythmias

    Time frame: Telemetry to 48 hours

    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.

Other outcomes

  1. Cardiac Infarct Size

    Time frame: Day 5 (+/- 2 days)

    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).

  2. Left Ventricular End-diastolic volume

    Time frame: Day 5

    Left Ventricular End-diastolic volume measurement from CMR will be used to assess cardiac function on Day 5 (+/- 2 days)

  3. Patient Reported Outcomes (PRO) Questionnaire

    Time frame: Day 30 (end of study)

    36-Item Short Form Health Survey (SF-36)

  4. Left Ventricular Ejection fraction

    Time frame: Day 2 and Day 30

    Left ventricular ejection fraction measurement from echocardiogram will be used to assess cardiac function prior to discharge and 30 days post primary PCI

  5. Left Ventricular End-systolic Volume

    Time frame: Day 2 and Day 30

    Left Ventricular Volume measurement from echocardiogram will be used to assess cardiac function prior to discharge and 30 days post primary PCI

  6. Left Ventricular Function

    Time frame: Day 2 and Day 30

    Left Ventricular Function measurement from echocardiogram will be used to assess cardiac function prior to discharge and 30 days post primary PCI

  7. Fractional shortening

    Time frame: Day 2 and 30

    Fractional shortening will be assessed via echocardiogram prior to discharge and at Day 30.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandra Suchowerska Director, Clinical Operations and Regulatory Affairs, PhD

CONTACT

[email protected]

+61 294-983-390

Sponsors and collaborators

Lead sponsor

Nyrada Pty Ltd

Industry

Registry information

Official study title

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

Acronym: PROTECT-MI

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 23, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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