Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction

NCT07362446 | Not Yet Recruiting Phase 2

• 1 other identifier: NYR-2A-001
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Myocardial Infarction; Reperfusion Injury; AMI; STEMI (ST Elevation MI)

Keywords

STEMI; PCI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Plasma concentration of Xolatryp during the 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

  pre-PCI ECG and first post procedural ECG

• Cardiac Injury Biomarkers

  48 hours post PCI

• Incidence of Arrhythmias

  Telemetry to 48 hours

Other Outcomes (7)

• Cardiac Infarct Size

  Day 5 (+/- 2 days)

• Left Ventricular End-diastolic volume

  Day 5

• Patient Reported Outcomes (PRO) Questionnaire

  Day 30 (end of study)

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

Xolatryp DRUG

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

Xolatryp intravenous infusion

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.

Placebo intravenous infusion

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Nyrada Pty Ltd: lead

Study Sites (5)

Nepean Hospital

Kingswood, New South Wales, 2747, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Northern Health

Epping, Victoria, 3076, Australia

Location

Sunshine Hospital

Saint Albans, Victoria, 3021, Australia

Location

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

Location

MeSH Terms

Conditions

Myocardial Infarction; Reperfusion Injury; ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Postoperative Complications

Central Study Contacts

Alexandra Suchowerska Director, Clinical Operations and Regulatory Affairs, PhD

CONTACT

+61 294-983-390; Protect-MI@Nyrada.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel assignment

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 23, 2026
• Study Start: April 16, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

AU (5)