NCT00343174

Intravenous Ancrod for the Treatment of Acute Ischemic Stroke Within 6 Hours After Onset of Symptoms

Multicenter Parallel Randomized Double-Blind Placebo Controlled Study of Efficacy and Safety of Intravenous Ancrod ( Arvin ) Given Within 6 Hours After the Onset of Acute Ischemic Stroke: European Stroke Treatment With Ancrod Trial ESTAT

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: —
• Sponsor: Heidelberg University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

Treatment of acute stroke is still difficult and the only specific drug approved (rtPA) can only be administered if treatment starts within 3 hours after onset of symptoms. This results in a still too small number of patients treated with rtPA ( \< 15% in best clinical care institutions ). Ancrod is a differently acting biological drug which has been used for a long time but not for acute stroke treatment. STAT was the first RCT of medium size to show a significant benefit/risk ration if treatment starts within 3 hours. ESTAT was designed closely related to STAT but with a longer 6 hours window and specifically extended inclusion/exclusion criteria to avoid secondary complications possibly related to a longer time window.

Conditions

• Brain Infarction
• Cerebral Ischemia
• Acute Stroke

Interventions

Type	Name	Description
DRUG	Ancrod

Timeline

• First posted: 2006-06-22
• Last updated: 2006-06-22