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

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00141011

Enrollment

277

Registered

2005-09-01

Start date

2005-09-30

Completion date

2008-12-31

Last updated

2009-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Infarction, Cerebral Ischemia, Stroke

Keywords

Stroke, Fibrinogen, Reperfusion, Thrombolysis

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.

Interventions

DRUGAncrod (Viprinex)

0.167 IU/kg/hr (0.6 mL/kg/hr) IV for 2-3 hours

DRUGPlacebo

0.6 mL/kg/hr

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Australia, Canada, Czechia, Netherlands, Poland, Russia, South Africa, Taiwan, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026