Stroke Treatment with Ancrod Trial "STAT"

Completed

Phase 3 Results

Trial Description

To evaluate the safety and efficacy of ancrod in patients with acute ischemic stroke.

Interventions

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

Trial Design

Randomized, parallel-group, double-blind, placebo-controlled study of 500 patients at 48 centers in the U.S. and Canada.

Patient Involvement

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.

Outcomes

Type Measure Time Frame Safety Issue
Primary Barthel Index at 3 months.
Secondary Scandinavian Stroke Scale, CT infarct volume.

Sponsors

Knoll Pharmaceutical, Mt. Olive, NJ