Background and purpose: Recombinant tissue plasminogen activator (rt-PA, alteplase) for acute ischaemic stroke was provisionally granted in Europe in 2002 and the granted license excluded many patient groups from treatment. Uncertainties about the balance of risk and benefit in several categories of patients still remain. The aim of the Third International Stroke Trial (IST-3) is to determine whether more patients can benefit from treatment. We present the rationale for the study and compare the characteristics of patients recruited to the study in Poland with those recruited in other countries.
Material and methods: Patients recruited to IST-3 from May 5th 2000 to April 9th 2008 (in Poland from November 2nd 2003). We compared the baseline characteristics for patients recruited in Poland and other countries.
Results: 1118 patients were recruited, 179 from centres in Poland and 939 from other countries. There was no significant difference between Poland and other countries in mean age (73.0 vs. 74.7 years), or distribution of gender (53.2% and 49.2% males), but the mean delay from onset to randomization was significantly longer (4.30 vs. 3.94 hours, p < 0.001), and baseline stroke severity was less (mean NIHSS 9.6 vs. 12.8, p < 0.001), respectively. The proportion of patients with a total anterior circulation clinical syndrome was lower, and lacunar and posterior circulation syndromes were more common among Polish patients.
Conclusions: Polish patients are somewhat different from those recruited in other countries, reflecting clinician's differing areas of uncertainty. These differences will be taken into account in the final trial analysis plan. The trial is still ongoing and more centres are welcome to join.