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The objective of this study is to evaluate CMX-2043 for prevention of renal and cardiac injury associated with coronary angiography in patients with acute coronary syndrome (ACS), but excluding ST-elevation myocardial infarction (STEMI) patients. This study will specifically examine the ability of CMX-2043 to prevent acute renal injury following coronary angiography. The study will also examine the ability of CMX 2043 for prevention of periprocedural cardiac injury. Information will be obtained relating to the ability of CMX 2043 for prevention of major adverse cardiac and renal events following the procedure. Additional information will be obtained in this study to evaluate safety of the drug. Dose and regimen information will also be obtained for future clinical studies of CMX-2043.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CMX-2043 2.4 mg/Kg | Experimental | Bolus injection of investigational product given prior to the cardiac catheterization and placebo given 24 hours after the first dose. |
|
| CMX-2043 3.6 mg/kg | Experimental | Bolus injection of investigational product given prior to the cardiac catheterization and placebo given 24 hours after the first dose. |
|
| CMX-2043 2.4 mg/kg given twice | Experimental | Bolus injection of investigational product given prior to the cardiac catheterization and again 24 hours after the first dose. |
|
| Placebo comparator | Placebo Comparator | Placebo comparator (PBS) given prior to cardiac catheterization and again 24 hours after the first dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CMX-2043 | Drug | Slow bolus IV administration of CMX-2043 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevention of acute kidney injury (AKI). | Reduction in the incidence of AKI as determined by the KDIGO definition of AKI compared to placebo. | Three days |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in biomarkers of AKI | Reduction in renal injury as determined by renal biomarkers in the treatment groups compared to placebo. | Three days |
| Trends in clinical outcomes | Incidence of major adverse cardiac events (MACE) or major adverse kidney events (MAKE) or other clinical complications in the treatment groups compared to placebo. |
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Inclusion Criteria:
Male or female subjects at least 18 years of age.
Subjects with acute coronary syndrome (excluding STEMI).
Subjects undergoing coronary angiography with the possibility of going on to PCI. However, if it is known that the patient is unlikely to undergo PCI, the patient should not be enrolled.
Subjects must meet either one of the following criteria:
i. Over 75 years of age ii. Diabetes mellitus iii. Ejection fraction less than 40% iv. Hypotension v. Congestive heart failure (NYHA stage II or higher) vi. Anemia (hemoglobin below 10 g/dL at screening)
Female subjects must also meet any one of the following criteria:
Subjects free of non-cardiac acute injuries or illnesses that, in the opinion of the investigator, could put the subject at risk or obscure the interpretation of results.
Subjects willing to undergo pre-and post-study blood and urine collection, physical exams and laboratory investigations.
Subjects willing to provide signed written informed consent form.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan S Lader, PhD | Ischemix, LLC | Study Director |
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| ID | Term |
|---|---|
| D000072658 | Non-ST Elevated Myocardial Infarction |
| D000789 | Angina, Unstable |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C000602148 | alpha-N-(1,2-dithiolane-3-pentanoyl)glutamylalanine |
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| Placebo comparator | Drug | Slow bolus IV administration of PBS |
|
| 90 days |
| Prevention of cardiac injury in unstable angina (UA) subjects who go on to PCI. | Reduction in cardiac injury as determined by cardiac biomarkers in the treatment groups compared to placebo | Three days |
| Safety monitoring | Assessments of treatment emergent adverse events. | 90 days |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D000787 | Angina Pectoris |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |