Enter Your Email Address to Receive a
Copy of MedicExhange Member Demograhpics

The investigational free radical-trapping neuroprotectant agent NXY-059 (AstraZeneca), developed for use in acute ischemic stroke, is safe to use in patients with intracerebral hemorrhage, according to results of the CHANT trial. The investigational free radical-trapping neuroprotectant agent NXY-059 (AstraZeneca), developed for use in acute ischemic stroke, is safe to use in patients with intracerebral hemorrhage, according to results of the CHANT (Cerebral Hematoma And NXY-059 Treatment) trial.

The CHANT investigators note in their report in the August issue of Stroke that if NYX-059 is to be used in stroke patients before baseline brain imaging, it has to be shown to be safe in patients with hemorrhagic stroke.

CHANT involved 603 patients with acute intracerebral hemorrhage who were randomized within six hours of symptom onset to intravenous NXY-059, 2270 mg for one hour followed by 960 mg/hour over the next 71 hours, or placebo.

Mean National Institutes of Health Stroke Scale (NIHSS) score on admission was 14 in both groups. Baseline hemorrhage volume was 22.4 ml in the study group and 23.3 ml in controls. Hemorrhages were secondary to hypertension or anticoagulant use in the majority of patients.

Mortality was 20.3 per cent in the NXY-059 group and 19.8 per cent in placebo patients, which was not a statistically significant difference.

The adverse event rate was the same in both groups overall, but the number of serious events was greater in the study group. Serum potassium fell in both groups, with a greater fall in the NXY-059-treated patients.

"However, no pattern emerged to indicate a safety concern," principal investigator Dr. Patrick D. Lyden of the University of California at San Diego and his colleagues report.

"NXY-059 therapy did not exacerbate the natural enlargement of intracerebral hemorrhage over 72 hours after treatment...If anything, the data are more consistent with attenuation of hemorrhage growth," the researchers write.

"There were no differences in three-month function, disability, or neurological deficit scores," the team reports. "The odds ratio for an improved outcome in three-month modified Rankin Scale (mRS) scores in the NXY-059 group was 1.01."

Overall, the CHANT investigators conclude, "There is no suggestion that NXY-059 benefits intracerebral hemorrhage patients.