To study the safety and efficacy of ancrod in patients with acute ischemic stroke administered within 6 hours of stroke onset.
- Ancrod (Viprinex®)Drug
Intervention Desc: Fibrinogenolytic agent. Purified fraction of pit viper venom, cleaves fibrinogen.
Double-blind, randomized, placebo-controlled trial involving 132 patients at 18 U.S. and German centers.
64 patients received intravenous ancrod (0.5 U/kg body wt) and 68 received placebo (250 ml of normal saline over 6 hours) initially. Subsequent doses were adjusted to achieve a fibrinogen level of 70 to 100 mg/dL.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Scandinavian Stroke Scale (SSS) score at 3 months compared to baseline.|
|Secondary||Clinical, laboratory, and radiographic measures. Also, activities of daily living and level of physical performance were assessed by the Barthel Index and the Rapid Disability Rating Scale.|