Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction

ConditionsMyocardial Infarction Reperfusion Injury AMI STEMI (ST Elevation MI)

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age40-75

SponsorNyrada Pty Ltd

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

300 Participants

are divided into 2 treatment groups

Group A: Xolatryp intravenous infusionExperimental treatment 1 intervention

Group B: Placebo intravenous infusionPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

From enrollment up to and including follow-up assessments on Day 30 (end of study)

Secondary outcomes

Plasma concentration of Xolatryp during the infusion

Blood sample(s) taken at 4 hours post the start of 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

Comparison between treatment groups of ST-segment elevation resolution calculated from pre-PCI ECG and first post procedural ECG

Time frame

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

Time frame

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.

Time frame

Telemetry to 48 hours

Other outcomes

Cardiac Infarct Size

Volumetric quantification comparison between treatment groups of cardiac infarct size parameters: Acute myocardial infarct size indexed to left ventricular mass, and Myocardial Salvage Index (MSI).

Time frame

Day 5 (+/- 2 days)

Left Ventricular End-diastolic volume

Left Ventricular End-diastolic volume measurement from CMR will be used to assess cardiac function on Day 5 (+/- 2 days)

Time frame

Day 5

Patient Reported Outcomes (PRO) Questionnaire

36-Item Short Form Health Survey (SF-36)

Time frame

Day 30 (end of study)

Left Ventricular Ejection fraction

Left ventricular ejection fraction measurement from echocardiogram will be used to assess cardiac function prior to discharge and 30 days post primary PCI

Time frame

Day 2 and Day 30

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nyrada Pty Ltd

Lead sponsor

Source ClinicalTrials.gov

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