Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

• Incidence of Adverse Events [Time frame: From enrollment up to and including follow-up assessments on Day 30 (end of study)]

Secondary outcome measures (4)

• 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]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Australia · 7 centers

• Nepean Hospital — Kingswood
• Liverpool Hospital — Liverpool
• Royal Adelaide Hospital — Adelaide
• Northern Health — Epping
• Sunshine Hospital — Saint Albans
• Sir Charles Gairdner Hospital — Nedlands
• Royal Perth Hospital — Perth

Identifiers

NCT: NCT07362446 · NYR-2A-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗