NCT00300196

ASP-II: Ancrod Stroke Program: Ancrod (Viprinex™) for the Treatment of Acute, Ischemic Stroke

ASP II (Ancrod Stroke Program) Study of Acute Viprinex™ for Emergency Stroke: A Randomized, Double-Blind, Placebo-Controlled Study of Ancrod (Viprinex™) in Subjects Beginning Treatment Within 6 Hours of the Onset of Acute Ischemic Stroke

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 311 (actual)
• Sponsor: Neurobiological Technologies · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to determine whether a brief intravenous infusion of ancrod started within 6 hours of stroke onset improves functional outcome at 3 months.

Detailed description

With prior approval by the FDA, an interim analysis for futility was performed when 500 subjects had been entered into the two parallel trials, NCT00141001 and NCT00300196. The analyses were reviewed by the data safety monitoring board, which recommended that both studies be terminated because of futility. This was done at a point where 650 subjects had been entered into both studies, combined, but analyses were conducted only on the initial 500 subjects. Results of the abbreviated analysis will be found with study NCT00141001 since that study contributed most of the subjects to the analysis.

Conditions

• Stroke
• Cerebral Ischemia
• Brain Infarction

Interventions

Type	Name	Description
BIOLOGICAL	Ancrod (Viprinex)	0.167 IU/kg/hr IV for 2-3 hours
DRUG	Placebo	0.6 mL/kg/hr

Timeline

• Start date: 2006-03-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2006-03-08
• Last updated: 2010-01-12

Locations

94 sites across 11 countries: United States, Australia, Austria, Czechia, Israel, New Zealand, Poland, Russia, Slovakia, South Africa, Switzerland