Ancrod (Viprinex™) for the Treatment of Acute, Ischemic Stroke - Full Text View

Sponsored by:	Neurobiological Technologies
Information provided by:	Neurobiological Technologies
ClinicalTrials.gov Identifier:	NCT00141011

Purpose

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	Intervention	Phase
Stroke Cerebral Ischemia Brain Infarction	Drug: Ancrod (Viprinex) Drug: Placebo	Phase III

Drug Information available for: Ancrod

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Neurobiological Technologies:

Primary Outcome Measures:

Responder analysis based on Modified Rankin Scale (mRS) [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

National Institute of Health Stroke Scale (NIHSS),Barthel Index (BI),Fibrinogen levels with ancrod tx, and Safety of ancrod tx [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	650
Study Start Date:	September 2005
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Ancrod (Viprinex) 0.167 IU/kg/hr (0.6 mL/kg/hr) IV for 2-3 hours
2: Placebo Comparator	Drug: Placebo 0.6 mL/kg/hr

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00141011

Contacts

Contact: Flavio S. Leonin, MD	201-624-2055	fleonin@ntii.com
Contact: Jane Fitzpatrick	201-941-4119	jfitzpatrick@ntii.com

Show 97 Study Locations

Sponsors and Collaborators

Neurobiological Technologies

Investigators

Study Director:

Warren Wasiewski, M.D.

Neurobiological Technologies

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Neurobiological Technologies, Inc. ( Warren W. Wasiewski, M.D. )
Study ID Numbers:	NTI-ASP-0502
Study First Received:	August 30, 2005
Last Updated:	September 17, 2008
ClinicalTrials.gov Identifier:	NCT00141011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Neurobiological Technologies:

Stroke
Fibrinogen
Reperfusion
Thrombolysis

Study placed in the following topic categories:

Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Ischemia
Ancrod
Brain Diseases

Cerebrovascular Disorders
Necrosis
Brain Ischemia
Emergencies
Brain Infarction
Infarction

Additional relevant MeSH terms:

Fibrin Modulating Agents
Anticoagulants
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents

Nervous System Diseases
Fibrinolytic Agents
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009