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

Phase 3

Terminated

• Conditions: Stroke; Cerebral Ischemia; Brain Infarction
• Interventions: Biological: Ancrod (Viprinex); Drug: Placebo

• Registration Number: NCT00300196
• Lead Sponsor: Neurobiological Technologies

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 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.

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-03-06
• Study First Submitted QC: 2006-03-06
• Study First Posted: 2006-03-08
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-11
• Last Update Posted: 2010-01-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 311

Inclusion Criteria

• Acute, ischemic stroke with first symptoms within 6 hours of beginning treatment
• Baseline NIHSS > 5

Exclusion Criteria

• No intracranial, extravascular blood on CT
• Hypertension (systolic > 185; diastolic > 105)
• Baseline fibrinogen level < 100 mg/dL
• Thrombocytopenia (< 100,000 / mm3)
• Recent (< 3 days) or anticipated (< 5 days) use of a thrombolytic agent
• Recent (< 14 days) or anticipated surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous ancrod	Ancrod (Viprinex)	Intravenous ancrod infused at a rate of 0.167 IU/kg/hr (0.6 mL/kg/hr) for 2 or 3 hours depending on the pretreatment fibrinogen level.
Intravenous Placebo	Placebo	Intravenous placebo at a rate of 0.6 mL/kg/hr for 2 or 3 hours depending on the pretreatment fibrinogen level.

Primary Outcome Measures

Name	Time	Method
Modified Rankin Score - responder analysis	90 days

Secondary Outcome Measures

Name	Time	Method
Barthel Index, NIHSS	90 days

Trial Locations

Locations (92)

Enloe Medical Center; 🇺🇸 Chico, California, United States

UCSF-Fresno; 🇺🇸 Fresno, California, United States

Sherry Braheny MD - A Prof. Corporation; 🇺🇸 La Mesa, California, United States

Mercy General Hospital; 🇺🇸 Sacramento, California, United States

Los Robles Hospital and Medical Center; 🇺🇸 Thousand Oaks, California, United States

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States

Manatee Memorial Hospital; 🇺🇸 Bradenton, Florida, United States

Bradenton Research Center; 🇺🇸 Bradenton, Florida, United States

Melbourne Internal Medicine Associates; 🇺🇸 Melbourne, Florida, United States

Collier Neurologic Specialists; 🇺🇸 Naples, Florida, United States

Scroll for more (82 remaining)