Argatroban TPA Stroke Study [SPOTRIAS] "ARTTS"

Recruiting

Phase N/A Results

Results

To date, 29 patients have been enrolled. All patients had anterior circulation strokes (proximal MCA and terminal ICA). The baseline median National Institute of Health Stroke Scale score is 12.5 (range, 3-25). Symptomatic intracerebral hemorrhage has occurred in 2 patients, including 1 with parenchymal hemorrhage type 2 (7%). Asymptomatic bleeding occurred in 2 patients and there was 1 death. Compared to historical controls of IV-tPA alone, the 2-hour rate of complete recanalization is more than doubled in the argatroban-treated patients (38% vs 13%). Conclusion: The combination of low-dose argatroban and intravenous rtPA may be safe, and produce faster and more complete recanalization, but a larger cohort of patients is required to confirm this pilot study. Assuming safety is confirmed, the recanalization data will be used to design a larger Phase III trial.