A pilot study of a new thrombolytic agent for acute ischemic stroke in Taiwan within a five-hour window

Han Hwa Hu, Michael Mu Huo Teng, Li Chi Hsu, Wen Jang Wong, Lee Min Wang, Yun On Luk, Chang Ming Chern, Bing Wen Soong, Wen Yung Sheng

Research output: Contribution to journalArticle

14 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)918-919
Number of pages2
JournalStroke
Volume37
Issue number3
DOIs
Publication statusPublished - Mar 1 2006
Externally publishedYes

Fingerprint

Fibrinolytic Agents
Taiwan
Stroke
Urokinase-Type Plasminogen Activator
Tissue Plasminogen Activator
Cerebral Hemorrhage
National Institutes of Health (U.S.)
Ecchymosis
Hemorrhage
Safety
Hematuria
Clinical Trials
Injections

Keywords

  • Stroke, ischemic
  • Thrombolytic therapy

ASJC Scopus subject areas

  • Clinical Neurology
  • Cardiology and Cardiovascular Medicine
  • Advanced and Specialised Nursing

Cite this

Hu, H. H., Teng, M. M. H., Hsu, L. C., Wong, W. J., Wang, L. M., Luk, Y. O., ... Sheng, W. Y. (2006). A pilot study of a new thrombolytic agent for acute ischemic stroke in Taiwan within a five-hour window. Stroke, 37(3), 918-919. https://doi.org/10.1161/01.STR.0000202591.18871.f7

A pilot study of a new thrombolytic agent for acute ischemic stroke in Taiwan within a five-hour window. / Hu, Han Hwa; Teng, Michael Mu Huo; Hsu, Li Chi; Wong, Wen Jang; Wang, Lee Min; Luk, Yun On; Chern, Chang Ming; Soong, Bing Wen; Sheng, Wen Yung.

In: Stroke, Vol. 37, No. 3, 01.03.2006, p. 918-919.

Research output: Contribution to journalArticle

Hu, HH, Teng, MMH, Hsu, LC, Wong, WJ, Wang, LM, Luk, YO, Chern, CM, Soong, BW & Sheng, WY 2006, 'A pilot study of a new thrombolytic agent for acute ischemic stroke in Taiwan within a five-hour window', Stroke, vol. 37, no. 3, pp. 918-919. https://doi.org/10.1161/01.STR.0000202591.18871.f7
Hu, Han Hwa ; Teng, Michael Mu Huo ; Hsu, Li Chi ; Wong, Wen Jang ; Wang, Lee Min ; Luk, Yun On ; Chern, Chang Ming ; Soong, Bing Wen ; Sheng, Wen Yung. / A pilot study of a new thrombolytic agent for acute ischemic stroke in Taiwan within a five-hour window. In: Stroke. 2006 ; Vol. 37, No. 3. pp. 918-919.
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AU - Luk, Yun On

AU - Chern, Chang Ming

AU - Soong, Bing Wen

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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.

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