Intravenous ancrod for acute ischaemic stroke in the European Stroke Treatment with Ancrod Trial: a randomised controlled trial.
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.


RESULTS
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).


CONCLUSIONS
On the basis of our findings, ancrod should not be recommended for use in acute ischaemic stroke beyond 3 h.
Hennerici
Michael G
MG
Department of Neurology, University of Heidelberg, Universitätsklinikum Mannheim, D-68135 Mannheim, Germany. Hennerici@neuro.ma.uni-heidelberg.de
Kay
Richard
R
Bogousslavsky
Julien
J
Lenzi
Gian Luigi
GL
Verstraete
Marc
M
Orgogozo
Jean Marc
JM
D000368:Aged; D000721:Ancrod / Q000008:administration & dosage / Q000627:therapeutic use*; D000925:Anticoagulants / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D020521:Stroke / Q000188:drug therapy* / Q000401:mortality; D016896:Treatment Outcome
D000925:Anticoagulants; D000721:Ancrod