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New drug aims to limit heart damage after major attack

NCT ID NCT07362446

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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).

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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.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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_RECRUITING

    Liverpool, New South Wales, 2170, Australia

  • Nepean Hospital

    RECRUITING

    Kingswood, New South Wales, 2747, Australia

  • Northern Health

    RECRUITING

    Epping, Victoria, 3076, Australia

  • Peninsula University Hospital

    NOT_YET_RECRUITING

    Frankston, Victoria, 3199, Australia

  • Royal Adelaide Hospital

    NOT_YET_RECRUITING

    Adelaide, South Australia, 5000, Australia

  • Royal Perth Hospital

    NOT_YET_RECRUITING

    Perth, Western Australia, 6000, Australia

  • Sir Charles Gairdner Hospital

    RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • Sunshine Hospital

    NOT_YET_RECRUITING

    Saint Albans, Victoria, 3021, Australia

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