TY - JOUR
T1 - A pilot study of a new thrombolytic agent for acute ischemic stroke in Taiwan within a five-hour window
AU - Hu, Han Hwa
AU - Teng, Michael Mu Huo
AU - Hsu, Li Chi
AU - Wong, Wen Jang
AU - Wang, Lee Min
AU - Luk, Yun On
AU - Chern, Chang Ming
AU - Soong, Bing Wen
AU - Sheng, Wen Yung
PY - 2006/3/1
Y1 - 2006/3/1
N2 - Background and Purpose - This study was the first clinical trial in Taiwan of a new thrombolytic agent human tissue urokinase type plasminogen activator (HTUPA) in patients with acute ischemic stroke. Methods - Patients were treated with a single bolus intravenous HTUPA under an open-label dose escalation design within 5 hours after symptom onset. Safety outcomes were assessed by symptomatic and asymptomatic intracerebral hemorrhage (ICH) as well as other bleeding episodes. Preliminary efficacy was measured by National Institutes of Health Stroke Scale (NIHSS). Results - Three doses of HTUPA (0.3 mg/kg, 0.35 mg/kg, and 0.4 mg/kg) were administered to 33 patients, with the majority of patients (n=29) receiving 0.3 mg/kg. Two cases of fatal ICH occurred: 1 in the patient who received 0.4 mg/kg and the other in the 0.3 mg/kg group. Asymptomatic ICH occurred in 6 patients. Other treatment-related serious adverse events were ecchymosis, hematuria, and upper gastrointestinal bleeding, which were completely recovered. At day 90, in patients treated with 0.3 mg/kg within a 0- to 5-hour window, 34% reached NIHSS scores 0 to 1, whereas of those treated within 0 to 3 hours, 86% reached this score. Conclusion - Intravenous HTUPA, given at 0.3 mg/kg as a bolus injection within 5 hours after symptom onset, had an acceptable safety and efficacious profile in patients with acute ischemic stroke.
AB - Background and Purpose - This study was the first clinical trial in Taiwan of a new thrombolytic agent human tissue urokinase type plasminogen activator (HTUPA) in patients with acute ischemic stroke. Methods - Patients were treated with a single bolus intravenous HTUPA under an open-label dose escalation design within 5 hours after symptom onset. Safety outcomes were assessed by symptomatic and asymptomatic intracerebral hemorrhage (ICH) as well as other bleeding episodes. Preliminary efficacy was measured by National Institutes of Health Stroke Scale (NIHSS). Results - Three doses of HTUPA (0.3 mg/kg, 0.35 mg/kg, and 0.4 mg/kg) were administered to 33 patients, with the majority of patients (n=29) receiving 0.3 mg/kg. Two cases of fatal ICH occurred: 1 in the patient who received 0.4 mg/kg and the other in the 0.3 mg/kg group. Asymptomatic ICH occurred in 6 patients. Other treatment-related serious adverse events were ecchymosis, hematuria, and upper gastrointestinal bleeding, which were completely recovered. At day 90, in patients treated with 0.3 mg/kg within a 0- to 5-hour window, 34% reached NIHSS scores 0 to 1, whereas of those treated within 0 to 3 hours, 86% reached this score. Conclusion - Intravenous HTUPA, given at 0.3 mg/kg as a bolus injection within 5 hours after symptom onset, had an acceptable safety and efficacious profile in patients with acute ischemic stroke.
KW - Stroke, ischemic
KW - Thrombolytic therapy
UR - http://www.scopus.com/inward/record.url?scp=33645089965&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=33645089965&partnerID=8YFLogxK
U2 - 10.1161/01.STR.0000202591.18871.f7
DO - 10.1161/01.STR.0000202591.18871.f7
M3 - Article
C2 - 16424373
AN - SCOPUS:33645089965
SN - 0039-2499
VL - 37
SP - 918
EP - 919
JO - Stroke
JF - Stroke
IS - 3
ER -
