The results of the European Cooperative Acute Stroke Study I (ECASS I), ECASS II and the ATLANTIS trial (Alteplase Thrombolysis for Acute Noninterventional Therapy in Ischaemic Stroke) showed that t-PA was not more effective than placebo in improving neurological outcome at 3 months.
The ECASS I trial employed a regime of 1.1 mg tPA per kg, a higher dose than in the NINDS rt-PA study and this seems to have led to a higher incidence of intracerebral haematoma 19.8 %. The ECASS II and ATLANTIS trials used a lower dose of 0.9 mg/kg with a combined incidence of 8% compared to 2.4% in the placebo group.
A post-hoc analysis of ECASS II has revealed a lower rate of death and dependency among thos patients treated with t-PA compared with those treated with placebo.
Critics of these trials suggest that compared to the NINDS trial therapy was
given much later.
- (1) Brott, Bogousslavsky (2000). Treatment of acute ischaemic stroke. NEJM,