Intravenous Ancrod for the Treatment of Acute Ischemic Stroke Within 6 Hours After Onset of Symptoms

Heidelberg University

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Conditions

Brain Infarction Cerebral Ischemia Acute Stroke

Interventions

AncrodDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.