Ancrod (Viprinex™) for the Treatment of Acute, Ischemic Stroke
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ClinicalTrials.gov Identifier: NCT00141011 |
Recruitment Status :
Terminated
(Futility)
First Posted : September 1, 2005
Last Update Posted : December 23, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Stroke Cerebral Ischemia Brain Infarction | Drug: Ancrod (Viprinex) Drug: Placebo | Phase 3 |
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 |
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.
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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.
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Drug: Placebo
0.6 mL/kg/hr |
- Responder analysis based on Modified Rankin Scale (mRS) [ Time Frame: 90 days ]
- National Institute of Health Stroke Scale (NIHSS),Barthel Index (BI),Fibrinogen levels with ancrod tx, and Safety of ancrod tx [ Time Frame: 90 days ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00141011

Study Director: | Warren Wasiewski, M.D. | Neurobiological Technologies |
Responsible Party: | Warren W. Wasiewski, M.D., Neurobiological Technologies, Inc. |
ClinicalTrials.gov Identifier: | NCT00141011 |
Other Study ID Numbers: |
NTI-ASP-0502 |
First Posted: | September 1, 2005 Key Record Dates |
Last Update Posted: | December 23, 2009 |
Last Verified: | December 2009 |
Stroke Fibrinogen Reperfusion Thrombolysis |
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 |