Effects of 0.6 mg/kg Intravenous Alteplase on Vascular and Clinical Outcomes in Middle Cerebral Artery Occlusion: Japan Alteplase Clinical Trial II (J-ACT II)

Etsuro Mori, Kazuo Minematsu, Jyoji Nakagawara, Takenori Yamaguchi, Makoto Sasaki, Teruyuki Hirano

Research output: Contribution to journalArticlepeer-review

103 Citations (Scopus)

Abstract

Background and Purpose: 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. Methods: 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. Results: 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. Conclusions:s: 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.

Original languageEnglish
Pages (from-to)461-465
Number of pages5
JournalStroke
Volume41
Issue number3
DOIs
Publication statusPublished - 2010 Mar

Keywords

  • Acute ischemic stroke
  • Magnetic resonance angiography
  • Middle cerebral artery occlusion
  • Recanalization
  • Tissue plasminogen activator

ASJC Scopus subject areas

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

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