Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial… (NCT07362446) | Clinical Trial Compass
RecruitingPhase 2
Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction
Australia300 participantsStarted 2026-04-22
Plain-language summary
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.
Who can participate
Age range
40 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ha…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 2 trial focused on preventing reperfusion injury after a heart attack — what does that mean for how much is already known about the safety of the cardioprotection approach being tested, and what risks should I be aware of?
2Since the trial is specifically enrolling STEMI patients, how would participating affect the timing and delivery of my standard emergency treatment like primary PCI, and could it delay or complicate my care in any way?
3The main thing being measured in this trial is adverse events — does that mean the primary goal right now is to understand what's safe rather than to prove the treatment works, and how might that affect what I personally could gain from joining?
4Are there standard-of-care options already available to help reduce reperfusion injury after my heart attack, and would it make more sense to try those before considering a Phase 2 trial like this one?
5Given that this trial is actively recruiting, what would my follow-up schedule look like, and is the level of monitoring and visits realistic given my recovery needs after a STEMI?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Adverse Events
Timeframe: From enrollment up to and including follow-up assessments on Day 30 (end of study)
Trial details
NCT IDNCT07362446
SponsorNyrada Pty Ltd
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2027-06-30
Contact for this trial
Alexandra Suchowerska Director, Clinical Operations and Regulatory Affairs, PhD