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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
361
Slow bolus IV administration of CMX-2043
Slow bolus IV administration of PBS
Prevention of acute kidney injury (AKI).
Reduction in the incidence of AKI as determined by the KDIGO definition of AKI compared to placebo.
Time frame: Three days
Reduction in biomarkers of AKI
Reduction in renal injury as determined by renal biomarkers in the treatment groups compared to placebo.
Time frame: 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.
Time frame: 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
Time frame: Three days
Safety monitoring
Assessments of treatment emergent adverse events.
Time frame: 90 days
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