To evaluate the safety and efficacy of ancrod in patients with acute ischemic stroke.
- Ancrod (Viprinex®)Drug
Intervention Desc: Fibrinogenolytic agent. Purified fraction of pit viper venom, cleaves fibrinogen.
Randomized, parallel-group, double-blind, placebo-controlled study of 500 patients at 48 centers in the U.S. and Canada.
Patients were randomized to receive IV ancrod, continuous IV infusion over 72 hours followed by 2 days of intermittent IV dosing (n=248) or placebo (n=252). Follow-up CT scan was performed 7-10 days after stroke to determine infarction volume and incidence of asymptomatic intracranial hemorrhage.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Barthel Index at 3 months.|
|Secondary||Scandinavian Stroke Scale, CT infarct volume.|