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

Neurobiological Technologies

Status and phase: Terminated; Phase 3

Conditions: Stroke; Cerebral Ischemia; Brain Infarction

Treatments: Drug: Placebo; Drug: Ancrod (Viprinex)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00141011

NTI-ASP-0502

Details and patient eligibility

About

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.

Full 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.

Enrollment: 277 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

277 participants in 2 patient groups, including a placebo group

Intravenous ancrod

Experimental group

Description:

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.

Treatment:

Drug: Ancrod (Viprinex)

Intravenous Placebo

Placebo Comparator group

Description:

Intravenous placebo at a rate of 0.6 mL/kg/hr for 2 or 3 hours depending on the pretreatment fibrinogen level.

Treatment:

Drug: Placebo