IV rTPA trials Flashcards
NINDS t-PA
National Institute of Neurological Disorders and Stroke t-PA trial
291 pts with AIS < 3 hrs
IV tpa 0.9mg/kg vs placebo
No difference in neurologic improvement at 24 hrs but patients given IV tPA were more likely than controls to have minimal or no disability at 3 months despite more symptomatic ICH (6.4% vs 0.6%)
no difference in mortality at 3 months
ECASS I
European Australasian Cooperative Acute Stroke Study
620 patients
< 6 hrs ischemic stroke
tPA 1.1mg/kg vs placebo
no difference in disability using intention to treat analysis
ECASS II
European Australasian Cooperative Acute Stroke Study II
800 patients
<6 hrs ischemic stroke
tPA 0.9mg/kg vs placebo
no significant difference was seen in the rate of favorable outcome at 3 months between rtPA and placebo treated group
ATLANTIS A
Alteplase Thrombolysis for Acute Non-Interventional Therapy in Ischemic Stroke
142 pts with AIS < 6 hrs
rtPA 0.9mg/kg vs placebo
no significant differenc eof the planned efficacy endpoints at 30 and 90 days
risk of symptomatic ICH higher in rtPA treatment
treatment given 5-6 hrs
ATLANTIS B
Alteplase Thrombolysis for Acute Non-Interventional Therapy in Ischemic Stroke
613 patients
AIS <3-5 hrs
rtPA vs placebo
no significant difference in functional recovery at 90 days between groups
risk of ICH increased in tPA
J-ACT
Japanes Alteplase Clinical Trial
103 pts
<3 hrs of AIS
0.6mg/kg rTPA vs placebo
36.9% achieved an mRS of 0-1 at 3 months
symptomatic ICH 5.8%
ECASS III
European Australasian Cooperative Acute Stroke Study III
821 pts
with AIS 3-4.5 hrs
rTPA 0.9mg/kg vs placebo
significantly more patients in rTPA treated group had favorable outcome at 3 months
52.4% vs 45.2% p=0.04
incidence of ICH higher in rTPA
mortality did not significantly differ
IST III
3,035 pts
<6 hrs AIS
rtPA vs placebo
more deaths occurred during first 7 days of rTPA