ABSTRACT
BACKGROUND: Intravenous tissue plasminogen activator is the only approved specific treatment for acute ischaemic stroke. Ancrod, a natural defibrinogenating agent from snake venom, has proved to have a favourable effect when given within 3 h after an acute ischaemic stroke. The European Stroke Treatment with Ancrod Trial was undertaken to assess the effects of ancrod when given within 6 h. METHODS: 1222 patients with an acute ischaemic stroke were included in this randomised double-blind placebo-controlled trial. Brain CT scans were done to exclude intracranial haemorrhages and large evolving ischaemic infarctions. Patients were randomly assigned ancrod (n=604) or placebo (n=618). The primary outcome was functional success at 3 months (survival, Barthel Index of 95 or 100, or return to prestroke level). The analysis was by intention-to-treat. This trial is registered with ClinicalTrials.gov, trial number NCT00343174. FINDINGS: Functional success at 3 months did not differ between patients given ancrod (42%) and those given placebo (42%) (p=0.94, OR=0.99, 95% CI, 0.76-1.29). INTERPRETATION: On the basis of our findings, ancrod should not be recommended for use in acute ischaemic stroke beyond 3 h.
Subject(s)
Ancrod/therapeutic use , Anticoagulants/therapeutic use , Stroke/drug therapy , Aged , Ancrod/administration & dosage , Anticoagulants/administration & dosage , Double-Blind Method , Female , Humans , Infusions, Intravenous , Male , Stroke/mortality , Treatment OutcomeABSTRACT
La terapéutica trombolítica podría significar un tratamiento eficaz del accidente cerebrovascular isquémico agudo. Sin embargo está todavía en etapa experimental. Se espera el resultado de estudios clínicos importantes para poder evaluar los riesgos potenciales inmediatos a su administración, así como también los beneficios a largo plazo (AU)
Subject(s)
Humans , Cerebrovascular Disorders/drug therapy , Thrombolytic Therapy , Fibrinolysis , Tissue Plasminogen Activator/therapeutic use , Fibrinolytic Agents/therapeutic useABSTRACT
La terapéutica trombolítica podría significar un tratamiento eficaz del accidente cerebrovascular isquémico agudo. Sin embargo está todavía en etapa experimental. Se espera el resultado de estudios clínicos importantes para poder evaluar los riesgos potenciales inmediatos a su administración, así como también los beneficios a largo plazo
