Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction (PROTECT-MI)

Nyrada Pty Ltd

Status and phase: Begins enrollment in 1 month; Phase 2

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

Treatments: Drug: Xolatryp; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07362446

NYR-2A-001

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

300 participants in 2 patient groups, including a placebo group

Xolatryp intravenous infusion

Experimental group

Description:

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.

Treatment:

Drug: Xolatryp

Placebo intravenous infusion

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo