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NCT07362446RecruitingPhase 2

Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction

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

Source: ClinicalTrials.gov · Last updated 4 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
300 (estimated)
First submitted
8 Jan 2026
Start date
2 Jul 2026
Primary completion date
30 Jun 2027
Lead sponsor
Nyrada Pty Ltd
NCT number
NCT07362446

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 300
  • From 2 Jul 2026 to the primary completion date, 30 Jun 2027
  • 8 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior major cardiac surgery, including but not limited to coronary artery bypass graft surgery (CABG).
  • 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.
  • 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).

Other illness

  • History or ECG evidence of myocardial infarction or cardiomyopathy.
  • 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.
  • 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.

Other

  • Estimated or known body weight \< 50 kg, \> 120 kg at screening.

Who the study is looking for

  • 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.

Age in the registry: 40 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (8)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Royal Adelaide Hospital
Coordinator of this site? Confirm its status
AdelaideAustraliaNot yet recruiting
Northern Health
Coordinator of this site? Confirm its status
EppingAustraliaRecruiting
Peninsula University Hospital
Coordinator of this site? Confirm its status
FrankstonAustraliaNot yet recruiting
Nepean Hospital
Coordinator of this site? Confirm its status
KingswoodAustraliaRecruiting
Liverpool Hospital
Coordinator of this site? Confirm its status
LiverpoolAustraliaRecruiting
Sir Charles Gairdner Hospital
Coordinator of this site? Confirm its status
NedlandsAustraliaRecruiting
Royal Perth Hospital
Coordinator of this site? Confirm its status
PerthAustraliaRecruiting
Sunshine Hospital
Coordinator of this site? Confirm its status
Saint AlbansAustraliaNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.