Ancrod Stroke Study

Completed

Phase 3 Results

Trial Description

To study the safety and efficacy of ancrod in patients with acute ischemic stroke administered within 6 hours of stroke onset.

Interventions

  • Ancrod (Viprinex┬«)Drug
    Intervention Desc: Fibrinogenolytic agent. Purified fraction of pit viper venom, cleaves fibrinogen.

Trial Design

Double-blind, randomized, placebo-controlled trial involving 132 patients at 18 U.S. and German centers.

Patient Involvement

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.

Outcomes

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.