Acute Stroke, Brain Infarction, Cerebral Ischemia
Conditions
Keywords
stroke, vascular diseases
Brief summary
Treatment of acute stroke is still difficult and the only specific drug approved (rtPA) can only be administered if treatment starts within 3 hours after onset of symptoms. This results in a still too small number of patients treated with rtPA ( \< 15% in best clinical care institutions ). Ancrod is a differently acting biological drug which has been used for a long time but not for acute stroke treatment. STAT was the first RCT of medium size to show a significant benefit/risk ration if treatment starts within 3 hours. ESTAT was designed closely related to STAT but with a longer 6 hours window and specifically extended inclusion/exclusion criteria to avoid secondary complications possibly related to a longer time window.
Interventions
DRUGAncrod
Sponsors
Heidelberg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* 18 years and above, both sexes * Acute ischemic stroke with first symptoms within 6 hours of beginning * Treatment after onset of symptoms * SSS \< 40 at baseline ( consciousness necessary )
Exclusion criteria
* Clinical or CT evidence of brain hemorrhage or hemorrhagic transformation * CT evidence of major signs of developing infarction * Coma * Prior strokes within 6 weeks * Severe hypertension (\> 220 systolic \> 120 mm Hg diastolic) * Baseline fibrinogen \< 100 mg/dL * Recent use of thrombolytic agents * Recent or anticipated surgery
Outcome results
None listed