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(Stroke. 2006;37:918.)
© 2006 American Heart Association, Inc.

Research Reports

A Pilot Study of a New Thrombolytic Agent for Acute Ischemic Stroke in Taiwan Within A Five-Hour Window

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

From the Departments of Neurology (H.-H.H., L.-C.H., W.-J.W., Y.-O.L., C.M.C., B.-W.S., W.-Y.S.), Radiology (M.-H.T.), and the emergency room (L.-M.W.), Taipei Veterans General Hospital, Taiwan.

Correspondence to Han-Hwa Hu, MD, Department of Neurology, Taipei Veterans General Hospital, 201 Shih-Pai Road, Sec 2 Taipei, Taiwan 11217. E-mail hhhu{at}vghtpe.gov.tw

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.

Key Words: stroke, ischemic • thrombolytic therapy