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

Phase 3

Terminated

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

• Registration Number: NCT00141011
• 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 First Submitted: 2005-08-30
• Study First Submitted QC: 2005-08-31
• Study Start: 2005-09
• Study First Posted: 2005-09-01
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-21
• Last Update Posted: 2009-12-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 277

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
Responder analysis based on Modified Rankin Scale (mRS)	90 days

Secondary Outcome Measures

Name	Time	Method
National Institute of Health Stroke Scale (NIHSS),Barthel Index (BI),Fibrinogen levels with ancrod tx, and Safety of ancrod tx	90 days

Trial Locations

Locations (100)

Mayo Clinic Hospital / Arizona; 🇺🇸 Phoenix, Arizona, United States

Sparks Regional Medical Center; 🇺🇸 Fort Smith, Arkansas, United States

Loma Linda University School of Medicine; 🇺🇸 Loma Linda, California, United States

Santa Monica - UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

Hoag Memorial Hospital; 🇺🇸 Newport Beach, California, United States

The Neurology Center: Tri-City Medical Center; 🇺🇸 Oceanside, California, United States

Shasta Regional Medical; 🇺🇸 Redding, California, United States

Bridgeport Hospital; 🇺🇸 Bridgeport, Connecticut, United States

Neurologic Consultants, P.A.; 🇺🇸 Fort Lauderdale, Florida, United States

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