New drug aims to limit heart damage after major attack
NCT ID NCT07362446
First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 10 times
Summary
This study tests a medicine called Xolatryp in adults who have had a severe heart attack (STEMI) and are getting a procedure to open blocked arteries. Participants receive either a single 6-hour infusion of Xolatryp or a placebo, and their heart health is monitored for 30 days. The goal is to see if Xolatryp is safe and helps the heart recover better.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jul 2026
- Expected to finish
-
Sep 2027
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
40 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for AMI are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
8 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Liverpool Hospital
NOT_YET_RECRUITINGLiverpool, New South Wales, 2170, Australia
-
Nepean Hospital
RECRUITINGKingswood, New South Wales, 2747, Australia
-
Northern Health
RECRUITINGEpping, Victoria, 3076, Australia
-
Peninsula University Hospital
NOT_YET_RECRUITINGFrankston, Victoria, 3199, Australia
-
Royal Adelaide Hospital
NOT_YET_RECRUITINGAdelaide, South Australia, 5000, Australia
-
Royal Perth Hospital
NOT_YET_RECRUITINGPerth, Western Australia, 6000, Australia
-
Sir Charles Gairdner Hospital
RECRUITINGNedlands, Western Australia, 6009, Australia
-
Sunshine Hospital
NOT_YET_RECRUITINGSaint Albans, Victoria, 3021, Australia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A blood test at 50 could flag your risk of five diseases. can an app stop them?
- Pharmacist and coach team takes aim at blood pressure after stroke
- Broken heart syndrome: is it as deadly as a heart attack?
- Fat graft may mend heart scars after a heart attack
- A simple breath test after a heart attack could prevent dangerous bleeding
- A simple ultrasound test may sharpen heart attack risk predictions