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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xolatryp intravenous infusion | Experimental | After randomization, patients receive primary PCI and standard therapy. Patients assigned to the experimental arm also receive Xolatryp, administered as a single, continuous intravenous infusion (i.v.) for 6 hours. |
|
| Placebo intravenous infusion | Placebo Comparator | After randomization, patients receive primary PCI and standard therapy. Patients assigned to the placebo arm also recieve a placebo comparator, administered as a single, continuous intravenous (i.v.) infusion for 6 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xolatryp | Drug | Patients assigned to the treatment arm recieve Xolatryp administered as a continuous intravenous (i.v) infusion for 6 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment up to and including follow-up assessments on Day 30 (end of study) |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of Xolatryp during the infusion | Blood sample(s) taken at 4 hours post the start of infusion | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Day 5 (+/- 2 days) |
| Left Ventricular End-diastolic volume |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandra Suchowerska Director, Clinical Operations and Regulatory Affairs, PhD | Contact | +61 294-983-390 | Protect-MI@Nyrada.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nepean Hospital | Recruiting | Kingswood | New South Wales | 2747 | Australia | |
| Liverpool Hospital |
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Parallel assignment
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Sponsor
| 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. |
|
Comparison between treatment groups of ST-segment elevation resolution calculated from pre-PCI ECG and first post procedural ECG |
| 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 | 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. | Telemetry to 48 hours |
Left Ventricular End-diastolic volume measurement from CMR will be used to assess cardiac function on Day 5 (+/- 2 days) |
| Day 5 |
| Patient Reported Outcomes (PRO) Questionnaire | 36-Item Short Form Health Survey (SF-36) | 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 | Day 2 and Day 30 |
| Left Ventricular End-systolic Volume | Left Ventricular Volume measurement from echocardiogram will be used to assess cardiac function prior to discharge and 30 days post primary PCI | Day 2 and Day 30 |
| Left Ventricular Function | Left Ventricular Function measurement from echocardiogram will be used to assess cardiac function prior to discharge and 30 days post primary PCI | Day 2 and Day 30 |
| Fractional shortening | Fractional shortening will be assessed via echocardiogram prior to discharge and at Day 30. | Day 2 and 30 |
| Not yet recruiting |
| Liverpool |
| New South Wales |
| 2170 |
| Australia |
| Royal Adelaide Hospital | Not yet recruiting | Adelaide | South Australia | 5000 | Australia |
| Northern Health | Not yet recruiting | Epping | Victoria | 3076 | Australia |
| Sunshine Hospital | Not yet recruiting | Saint Albans | Victoria | 3021 | Australia |
| Sir Charles Gairdner Hospital | Recruiting | Nedlands | Western Australia | 6009 | Australia |
| Royal Perth Hospital | Not yet recruiting | Perth | Western Australia | 6000 | Australia |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D015427 | Reperfusion Injury |
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D011183 | Postoperative Complications |
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