Myocardial InfarctionPhase 2PROTECT-MINCT07362446
Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction
A Phase 2 study testing Xolatryp in people with Myocardial Infarction and Reperfusion Injury, run by Nyrada Pty Ltd at 8 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Myocardial Infarction, Reperfusion Injury, AMI
- What is being tested?
- Xolatryp
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 8 sitesAustralia
- Study dates
- 2 Jul 2026to 30 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Alexandra Suchowerska Director, Clinical Operations and Regulatory Affairs, PhD contact
8 sites in 1 country
Australia8 sites, 8 recruiting
- Not yet recruiting
Royal Adelaide Hospital
Adelaide, South Australia, 5000
- Recruiting
Northern Health
Epping, Victoria, 3076
- Not yet recruiting
Peninsula University Hospital
Frankston, Victoria, 3199
- Recruiting
Nepean Hospital
Kingswood, New South Wales, 2747
- Recruiting
Liverpool Hospital
Liverpool, New South Wales, 2170
- Recruiting
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
- Recruiting
Royal Perth Hospital
Perth, Western Australia, 6000
- Not yet recruiting
Sunshine Hospital
Saint Albans, Victoria, 3021
About this study
Official title: 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.
Read more
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.
- Being tested
- Xolatryp, Placebo
- Keywords
- STEMI, PCI
- Medical subject headings
- Myocardial Infarction, Reperfusion Injury, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XolatrypDrug
Patients assigned to the treatment arm recieve Xolatryp administered as a continuous intravenous (i.v) infusion for 6 hours.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Xolatryp intravenous infusion | Experimental | 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. Receives: Drug: Xolatryp |
| Placebo intravenous infusion | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment up to and including follow-up assessments on Day 30 (end of study)
Secondary outcomes (4)
Plasma concentration of Xolatryp during the infusion
Blood sample(s) taken at 4 hours post the start of infusion
Measured: 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
Measured: 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
Measured: 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.
Measured: Telemetry to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start2 Jul 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nyrada Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07362446
- Sponsor's protocol ID
- NYR-2A-001
- Acronym
- PROTECT-MI
- Status last verified
- Nov 2026
- First submitted
- 8 Jan 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Blind, Placebo-Controlled, Study of Xolatryp in Patients Presenting With STEMI Undergoing Primary PCI
- ClinicalTrials.gov ID
- NCT07362446
- Acronym / sponsor ID
- PROTECT-MI / NYR-2A-001
- Keywords
- STEMI, PCI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Nyrada Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 2 Jul 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Xolatryp intravenous infusion | Experimental | Drug: XolatrypAfter 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. |
| Placebo intravenous infusion | Placebo comparator | Drug: PlaceboAfter 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XolatrypPatients assigned to the treatment arm recieve Xolatryp administered as a continuous intravenous (i.v) infusion for 6 hours. | Drug | Xolatryp intravenous infusion |
| PlaceboPatients 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. | Drug | Placebo intravenous infusion |
Primary outcome
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.
4 secondary outcomes
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.
ST-segment elevation resolution
Time frame: pre-PCI ECG and first post procedural ECG
Cardiac Injury Biomarkers
Time frame: 48 hours post PCI
Incidence of Arrhythmias
Time frame: Telemetry to 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexandra Suchowerska Director, Clinical Operations and Regulatory Affairs, PhD contact
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Xolatryp in people with Myocardial Infarction and Reperfusion Injury, run by Nyrada Pty Ltd at 8 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Suchowerska Director, Clinical Operations and Regulatory Affairs, PhD (+61 294-983-390, Protect-MI@Nyrada.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (time frame: From enrollment up to and including follow-up assessments on Day 30 (end of study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.