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

• ClinicalTrials.gov Identifier: NCT00141011
• Recruitment Status: Terminated
• First Posted: September 1, 2005
• Last Update Posted: December 23, 2009
• Sponsor: Neurobiological Technologies
• Information provided by: Neurobiological Technologies

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Stroke; Cerebral Ischemia; Brain Infarction	Drug: Ancrod (Viprinex); Drug: Placebo	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 277 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Within 6 Hours of the Onset of Acute, Ischemic Stroke
• Study Start Date: September 2005
• Actual Primary Completion Date: December 2008
• Actual Study Completion Date: December 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intravenous ancrod; 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.	Drug: Ancrod (Viprinex); 0.167 IU/kg/hr (0.6 mL/kg/hr) IV for 2-3 hours
Placebo Comparator: Intravenous Placebo; Intravenous placebo at a rate of 0.6 mL/kg/hr for 2 or 3 hours depending on the pretreatment fibrinogen level.	Drug: Placebo; 0.6 mL/kg/hr

Outcome Measures

Primary Outcome Measures :

1. Responder analysis based on Modified Rankin Scale (mRS) [ Time Frame: 90 days ]

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

  Show 100 Study Locations

Sponsors and Collaborators

Neurobiological Technologies

Investigators

• Study Director: Warren Wasiewski, M.D.; Neurobiological Technologies

More Information

• Responsible Party: Warren W. Wasiewski, M.D., Neurobiological Technologies, Inc.
• ClinicalTrials.gov Identifier: NCT00141011 History of Changes
• Other Study ID Numbers: NTI-ASP-0502
• First Posted: September 1, 2005
• Last Update Posted: December 23, 2009
• Last Verified: December 2009

Keywords provided by Neurobiological Technologies:

Stroke; Fibrinogen; Reperfusion; Thrombolysis

Additional relevant MeSH terms:

Ancrod; Stroke; Brain Ischemia; Cerebral Infarction; Brain Infarction; Infarction; Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Necrosis; Anticoagulants; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action