Early intravenous thrombolysis within the first three hours has been consid
ered in the United States as the first proven treatment in acute ischemic s
troke. However, not all patients will respond to this therapy which is also
associated with a risk of symptomatic, including fatal, intracranial hemor
rhage. This overview addresses the issue of efficacy and safety of intraven
ous alteplase (tPA) in acute cerebral ischemia. The rationale for thromboly
tic therapy and its limits are described. The controlled studies show that
intravenous tPA is effective and safe when given tinder restrictive conditi
ons within 3 hours after stroke onset, but the data for a larger therapeuti
c window between 3 and 6 hours remain controversial. The expected functiona
l improvement and the risk of intracranial hemorrhage greatly depend on sel
ective clinical and imaging criteria. For this purpose, MRI, using the diff
usion- and perfusion-weighted sequences combined with MR- angiography, shou
ld be preferred to CT scan in the next future. Applicability of tPA thrombo
lysis in current neurological practice in Belgium is discussed. Before its
generalization, this therapy should be restricted to specialized stroke cen
ters and all treated patients should be recorded in a central data bank to
guarantee continued surveillance.