Health Trials

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

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

Treatments tested in this trial

  • Xolatryp
  • Placebo

Treatment groups

300 Participants
are divided into 2 treatment groups

Locations

7
Nepean Hospital2747, KingswoodNew South Wales, Australia
Liverpool Hospital2170, LiverpoolNew South Wales, Australia
Royal Adelaide Hospital5000, AdelaideSouth Australia, Australia
Northern Health3076, EppingVictoria, Australia

Sponsors and collaborators

Nyrada Pty Ltd

Lead sponsor

Source ClinicalTrials.gov