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Prevention study for Myocardial Infarction
Official title Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction
ClinicalTrials.gov ID: NCT07362446
What this study is testing
What is Xolatryp?
Xolatryp is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for myocardial infarction.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 75
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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 \ 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...
See the full eligibility 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.
- 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 \ 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...
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Kingswood, New South Wales, Australia
- Liverpool, New South Wales, Australia
- Adelaide, South Australia, Australia
- Epping, Victoria, Australia
- Saint Albans, Victoria, Australia
- Nedlands, Western Australia, Australia
- Perth, Western Australia, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kingswood, New South Wales, Australia; Liverpool, New South Wales, Australia; Adelaide, South Australia, Australia; Epping, Victoria, Australia; Saint Albans, Victoria, Australia; Nedlands, Western Australia, Australia and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.