Clinical Trial: Ancrod (Viprinex™) for the Treatment of Acute, Ischemic Stroke

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: ASP I (Ancrod Stroke Program) Study of Acute Viprinex™ for Emergency Stroke: A Randomized, Double-Blind, Placebo-Controlled Study of Ancrod (Viprinex™) in Subjects Beginning Treatment With

Brief 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 Summary: 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.
Sponsor: Neurobiological Technologies

Current Primary Outcome: Responder analysis based on Modified Rankin Scale (mRS) [ Time Frame: 90 days ]

Original Primary Outcome: Barthel Index

Current Secondary Outcome: National Institute of Health Stroke Scale (NIHSS),Barthel Index (BI),Fibrinogen levels with ancrod tx, and Safety of ancrod tx [ Time Frame: 90 days ]

Original Secondary Outcome: Modified Rankin Score

Information By: Neurobiological Technologies

Dates:
Date Received: August 30, 2005
Date Started: September 2005
Date Completion:
Last Updated: December 21, 2009
Last Verified: December 2009