More than half of the global population now lives in Asia. With rapid economic transition, the burden of stroke is becoming an important issue in Asian countries [1,2]. Intravenous tissue-type plasminogen activator (t-PA) at a dose of 0.9 mg kg−1 has been proved to be effective in Western countries for patients with acute ischemic stroke within 3 h of onset [3,4]. However, this standard-dose t-PA poses several concerns for Asians, including its safety profile and cost. On the basis of experience from duteplase trials and racial differences in blood coagulation, a single-arm study conducted in Japan, the Japan Alteplase Clinical Trial (J-ACT), using 0.6 mg kg−1 t-PA for stroke thrombolysis, reported similar efficacy and bleeding risk as those found with the standard dose . On the other hand, several studies in other Asian populations outside Japan, focusing on the dose regimen and safety/efficacy, reported contradictory results [6–9]. However, none of these studies was randomized, and the definition of low dose was diverse, with t-PA doses ranging from 0.6 to 0.85 mg kg−1 [6–9] or to a cap of a maximum of 50 mg, owing to concerns over cost [7–9]. Therefore, it was not possible to determine the optimal dose of t-PA for Asian patients with acute ischemic stroke.
This study compared the safety and efficacy of two prespecified doses – low dose (0.7 mg kg−1) and standard dose (0.9 mg kg−1) – in two medical centers with resident-based stroke treatment protocols and high-volume thrombolysis in Taiwan.