1. CARIN
Trial design: Patients undergoing coronary angiography were randomized in a 1:1:1:1 fashion to CMX mg/kg, 3.6 mg/kg, 4.8 mg/kg, or placebo. Patient follow-up was 90 days.
Results
(p > 0.05)
Primary outcome, acute kidney injury (AKI) at 4 days for CMX mg/kg vs. 3.6 mg/kg vs. 4.8 mg/kg vs. placebo: 25.6% vs. 25.3% vs. 18.9% vs. 18.6%, p > 0.05
Mean eGFR at 90 days (ml/min): 42.7 vs vs vs. 44.6, p > 0.05; dialysis: 1.2% vs. 1.1% vs. 0% vs. 1.1%, p > 0.05
MACE: 2.4% vs. 11.1% vs. 3.8% vs. 4.5%, p > 0.05
100 % 50
Conclusions
CMX-2043, a potent version of alpha-lipoic acid, at 3 different doses was not more efficacious than placebo in reducing AKI following coronary angiography/PCI
There were also no differences in periprocedural MI or other CV outcomes
Primary endpoint
CMX-2043
2.4 mg/kg
(n = 87)
CMX-2043
3.6 mg/kg
(n = 94)
CMX-2043
4.8 mg/kg
(n = 87)
Placebo
(n = 93)
Presented by Dr. Deepak L. Bhatt at ACC 2016