ASP I (Ancrod Stroke Program)

INTERVENTION: Product Name: Ancrod (Viprinex™) Pharmaceutical Form: Solution for injection INN or Proposed INN: Ancrod Other descriptive name: Arvin, Arwin, Lukrod Concentration unit: IU/ml international unit(s)/millilitre Concentration type: equal Concentration number: 70‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous use CONDITION: Acute Ischemic Stroke PRIMARY OUTCOME: Main Objective: The primary objective of this study is to evaluate the efficacy of ancrod versus placebo, administered intravenously within 6 hours of stroke onset to subjects with an acute ischemic stroke, as determined by a responder analysis based on Modified Rankin Scale (mRS) score at Day 90. Primary end point(s): reducing the incidences of disability at day 90 after start of treatment Secondary Objective: The secondary objectives are as follows:; • To evaluate the efficacy of ancrod versus placebo as determined by National; Institutes of Health Stroke Scale (NIHSS) score at Day 90; • To evaluate the efficacy of ancrod versus placebo as determined by Barthel Index; (BI) score at Day 90; • To evaluate fibrinogen levels associated with ancrod treatment; • To evaluate the safety of ancrod treatment INCLUSION CRITERIA: 1. Sudden onset of an ischemia‐related neurologic deficit involving the carotid, vertebrobasilar, or cerebral artery territories within 6 hours prior to screening, with symptoms persisting for = 30 minutes Subjects that awaken with stroke symptoms can be enrolled if they were without symptoms within the 6‐hour window. 2. Clinical diagnosis of acute ischemic stroke based on a general physical examination, neurologic examination, and neuroimaging findings 3. Stroke symptoms occurring at a time that would allow initiation of study treatment within 6 hours of recognized onset Subjects will not be excluded based on CT evidence of the index ischemic stroke, but Investigators should be fully satisfied that they have determined the time of symptom onset if there is extensive change related to the index stroke. 4. No conditions other than stroke to which the subject's sudden clinical deterioration could have been attributed (e.g., pneumonia or