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Effects of 0.6 mg/kg Intravenous Alteplase on Vascular and Clinical Outcomes in Middle Cerebral Artery Occlusion
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- Etsuro Mori
- From the Department of Behavioral Neurology and Cognitive Neuroscience (E.M.), Tohoku University Graduate School of Medicine, Sendai, Japan; Cerebrovascular Division (K.M.), National Cardiovascular Center, Suita, Japan; the Department of Neurosurgery and Stroke Center (J.N.), Nakamura Memorial Hospital, Sapporo, Japan; the National Cardiovascular Center (T.Y.), Suita, Osaka, Japan; Advanced Medical Research Center (M.S.), Iwate Medical University, Morioka, Japan; and the Department of Neurology (T.H...
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- Kazuo Minematsu
- From the Department of Behavioral Neurology and Cognitive Neuroscience (E.M.), Tohoku University Graduate School of Medicine, Sendai, Japan; Cerebrovascular Division (K.M.), National Cardiovascular Center, Suita, Japan; the Department of Neurosurgery and Stroke Center (J.N.), Nakamura Memorial Hospital, Sapporo, Japan; the National Cardiovascular Center (T.Y.), Suita, Osaka, Japan; Advanced Medical Research Center (M.S.), Iwate Medical University, Morioka, Japan; and the Department of Neurology (T.H...
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- Jyoji Nakagawara
- From the Department of Behavioral Neurology and Cognitive Neuroscience (E.M.), Tohoku University Graduate School of Medicine, Sendai, Japan; Cerebrovascular Division (K.M.), National Cardiovascular Center, Suita, Japan; the Department of Neurosurgery and Stroke Center (J.N.), Nakamura Memorial Hospital, Sapporo, Japan; the National Cardiovascular Center (T.Y.), Suita, Osaka, Japan; Advanced Medical Research Center (M.S.), Iwate Medical University, Morioka, Japan; and the Department of Neurology (T.H...
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- Takenori Yamaguchi
- From the Department of Behavioral Neurology and Cognitive Neuroscience (E.M.), Tohoku University Graduate School of Medicine, Sendai, Japan; Cerebrovascular Division (K.M.), National Cardiovascular Center, Suita, Japan; the Department of Neurosurgery and Stroke Center (J.N.), Nakamura Memorial Hospital, Sapporo, Japan; the National Cardiovascular Center (T.Y.), Suita, Osaka, Japan; Advanced Medical Research Center (M.S.), Iwate Medical University, Morioka, Japan; and the Department of Neurology (T.H...
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- Makoto Sasaki
- From the Department of Behavioral Neurology and Cognitive Neuroscience (E.M.), Tohoku University Graduate School of Medicine, Sendai, Japan; Cerebrovascular Division (K.M.), National Cardiovascular Center, Suita, Japan; the Department of Neurosurgery and Stroke Center (J.N.), Nakamura Memorial Hospital, Sapporo, Japan; the National Cardiovascular Center (T.Y.), Suita, Osaka, Japan; Advanced Medical Research Center (M.S.), Iwate Medical University, Morioka, Japan; and the Department of Neurology (T.H...
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- Teruyuki Hirano
- From the Department of Behavioral Neurology and Cognitive Neuroscience (E.M.), Tohoku University Graduate School of Medicine, Sendai, Japan; Cerebrovascular Division (K.M.), National Cardiovascular Center, Suita, Japan; the Department of Neurosurgery and Stroke Center (J.N.), Nakamura Memorial Hospital, Sapporo, Japan; the National Cardiovascular Center (T.Y.), Suita, Osaka, Japan; Advanced Medical Research Center (M.S.), Iwate Medical University, Morioka, Japan; and the Department of Neurology (T.H...
Bibliographic Information
- Other Title
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- Japan Alteplase Clinical Trial II (J-ACT II)
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Description
<jats:p> <jats:bold> <jats:italic>Background and Purpose—</jats:italic> </jats:bold> The purpose of this study was to evaluate further the efficacy of 0.6 mg/kg intravenous alteplase on vascular and clinical outcomes in patients with middle cerebral artery occlusion in a postmarketing Phase IV trial of prospective cohort study design. </jats:p> <jats:p> <jats:bold> <jats:italic>Methods—</jats:italic> </jats:bold> Alteplase was given intravenously at 0.6 mg/kg to patients with ischemic stroke within 3 hours of onset with MR angiography-documented middle cerebral artery occlusion. Vascular outcome was evaluated by MR angiography at 6 and 24 hours after symptom onset based on the modified Mori grade. The primary end points also included a favorable outcome (modified Rankin Scale 0 to 1 at 3 months after onset) and incidence of symptomatic intracranial hemorrhage within 36 hours after treatment. The impact of recanalization on clinical outcome was assessed by stepwise logistic regression analysis. </jats:p> <jats:p> <jats:bold> <jats:italic>Results—</jats:italic> </jats:bold> Fifty-eight patients were enrolled. Recanalization was noted in 51.7% on 6-hour MR angiography and 69.0% on 24-hour MR angiography. A favorable clinical outcome was achieved in 46.6%. None had symptomatic intracranial hemorrhage. In logistic regression models, recanalization on either 6-hour or 24-hour MR angiography was an independent predictor for clinical outcome as well as the baseline National Institutes of Health Stroke Scale score. </jats:p> <jats:p> <jats:bold> <jats:italic>Conclusions—</jats:italic> </jats:bold> Early recanalization of an occluded middle cerebral artery can be provoked by 0.6 mg/kg intravenous alteplase and may induce a favorable clinical outcome. The rates of recanalization and favorable outcome are comparable to that previously reported with the 0.9-mg/kg dose. </jats:p>
Journal
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- Stroke
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Stroke 41 (3), 461-465, 2010-03
Ovid Technologies (Wolters Kluwer Health)