This study evaluated the safety and efficacy of
batroxobin in treating hyperfibrinogenemia for secondary
stroke prevention. Patients with
ischemic stroke or
transient ischemic attack (TIA) were measured for plasma
fibrinogen levels. Selected participants had concomitant hyperfibrinogenemia (plasma
fibrinogen > or = 3.0 g/l). Patients enrolled between 1 July 2003 and 31 December 2004 were treated with
batroxobin; patients enrolled between 1 January 2002 and 30 June 2003 were treated without
batroxobin.
Batroxobin was administered intermittently via
intravenous injection at 3-monthly intervals. Patients in both groups were followed for 1 year. Any cerebrovascular events and suspected adverse events were recorded. In total, 112
ischemic stroke/TIA patients with concomitant hyperfibrinogenemia were enrolled, 52 being treated with
batroxobin and 60 without
batroxobin. Six patients (11.5%) with
batroxobin and 16 patients (26.7%) without
batroxobin had recurrent cerebral ischemic events during follow-up.
Stroke/TIA recurrence in patients without
batroxobin was higher than that in patients with
batroxobin (P < 0.05). Two patients with
batroxobin and two patients without
batroxobin developed
hemorrhagic stroke during follow-up. There were five deaths (9.6%) in the
batroxobin group, and seven deaths (11.7%) in the nonbatroxobin group during follow-up (P > 0.05). Intermittent
intravenous injection of
batroxobin can efficiently reduce the risk for
stroke/TIA recurrence in patients with concomitant hyperfibrinogenemia.