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).

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:

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.

• Authors: Etsuro Mori, Kazuo Minematsu, Jyoji Nakagawara, Takenori Yamaguchi, Makoto Sasaki, Teruyuki Hirano, Japan Alteplase Clinical Trial II Group
• Journal: Stroke (Stroke) Vol. 41 Issue 3 Pg. 461-5 (Mar 2010) ISSN: 1524-4628 [Electronic] United States
• PMID: 20075341 (Publication Type: Clinical Trial, Phase II, Clinical Trial, Phase IV, Comparative Study, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Tissue Plasminogen Activator

Topics

• Aged
• Aged, 80 and over
• Cohort Studies
• Female
• Humans
• Infarction, Middle Cerebral Artery (diagnostic imaging, drug therapy)
• Injections, Intravenous
• Japan
• Magnetic Resonance Angiography (methods)
• Male
• Middle Aged
• Middle Cerebral Artery (diagnostic imaging, drug effects)
• Prospective Studies
• Radiography
• Time Factors
• Tissue Plasminogen Activator (administration & dosage)
• Treatment Outcome