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.
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.
Trial Stopped: Futility
- Ancrod (Viprinex®)Drug
Intervention Desc: Fibrinogenolytic agent. Purified fraction of pit viper venom, cleaves fibrinogen.
- Placebo Drug
Intervention Desc: 0.6 mL/kg/hr ARM 1: Kind: Experimental Label: Intravenous Placebo Description: Intravenous placebo at a rate of 0.6 mL/kg/hr for 2 or 3 hours depending on the pretreatment fibrinogen level.
- Ancrod (Viprinex) Biological
Intervention Desc: 0.167 IU/kg/hr (0.6 mL/kg/hr) IV for 2-3 hours ARM 1: Kind: Experimental Label: Intravenous ancrod 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.
- Allocation: Randomized
- Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
Patients receive a one-time, 2-3 hour infusion of ancrod or placebo within six hours of the initial symptom onset of their ischemic stroke, and are then followed for three months to collect information on their functional status.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Modified Rankin Scale – responder analysis.|
|Secondary||Barthel Index, NIH Stroke Scale Score.|
|Primary||Responder analysis based on Modified Rankin Scale (mRS)||90 days||No|
|Secondary||National Institute of Health Stroke Scale (NIHSS),Barthel Index (BI),Fibrinogen levels with ancrod tx, and Safety of ancrod tx||90 days||No|