Published Online
on June 8, 2006

A more recent version of this article appeared on July 1, 2006

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Submitted on February 10, 2006
Revised on March 27, 2006
Accepted on April 24, 2006

Alteplase at 0.6 mg/kg for Acute Ischemic Stroke Within 3 Hours of Onset. Japan Alteplase Clinical Trial (J-ACT)

Takenori Yamaguchi MD^*; Etsuro Mori MD; Kazuo Minematsu MD; Jyoji Nakagawara MD; Kazuo Hashi MD; Isamu Saito MD; Yukito Shinohara MD; for the Japan Alteplase Clinical Trial (J-ACT) Group

From the National Cardiovascular Center (T.Y., K.M.), Osaka, Japan; Tohoku University Graduate School of Medicine (E.M.), Miyagi, Japan; Nakamura Memorial Hospital (J.N.), Hokkaido, Japan; Pacific Neurosurgical Consulting (K.H.) Hokkoido, Japan; Fuji Brain Institute and Hospital (I.S.), Shizuoka, Japan; and Tokai University Tokyo Hospital (Y.S.), Tokyo, Japan.

^* To whom correspondence should be addressed. E-mail: tyamaguc{at}hsp.ncvc.go.jp.

Background and Purpose--Based on previous studies comparing different recombinant tissue plasminogen activator (rt-PA) doses, we performed a clinical trial with 0.6 mg/kg, which is lower than the internationally approved dosage of 0.9 mg/kg, aiming to assess the efficacy and safety of alteplase in acute ischemic stroke for the Japanese.

Methods--Our prospective, multicenter, single-arm, open-label trial was designed with a target sample size of 100 patients. The primary end points were the proportion of patients with a modified Rankin Scale (mRS) score of 0 to 1 at 3 months and the incidence of symptomatic intracranial hemorrhage (sICH) within 36 hours. Thresholds for these end points were determined by calculating 90% CIs of weighted averages derived from published reports. The protocol was defined according to the National Institute of Neurological Disorders and Stroke (NINDS) rt-PA stroke study with slight modifications.

Results--Among the 103 patients enrolled, 38 had an mRS of 0 to 1 at 3 months; this proportion (36.9%) exceeded the predetermined threshold of 33.9%. sICH within 36 hours occurred in 6 patients; this incidence (5.8%) was lower than the threshold of 9.6%.

Conclusions--In patients receiving 0.6 mg/kg alteplase, the outcome and the incidence of sICH were comparable to published data for 0.9 mg/kg. These findings indicate that alteplase, when administered at 0.6 mg/kg to Japanese patients, might offer a clinical efficacy and safety that are compatible with data reported in North America and the European Union for a 0.9 mg/kg dose.

Key words: stroke, acute • thrombolytic therapy • tissue plasminogen activator

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