Post-marketing Clinical Study of Alteplase for Acute Ischemic Stroke (Japan Alteplase Clinical Trial Ⅱ:J-ACT Ⅱ)


Phase 4 Results

Summary of Purpose

The purpose of this study is to confirm the efficacy and safety of intravenously administered alteplase in patients with acute ischemic stroke based on the rate of recanalization assessed by magnetic resonance angiography (MRA), the rate of patients with a modified Rankin Scale (mRS) score of 0-1, and the incidence of symptomatic intracranial hemorrhage (sICH), in comparison with the data reported in the current...

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Trial Milestones

The following dates are available for this trial. Trial information last updated on 20 December 2017.

1 Dec 2006 17 Dec 2006 1 Jun 2008 1 Jun 2008 1 Dec 2017 19 Jan 2012
Start Date First Received 1st Completion Completion Verification Results

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment


  • Mitsubishi Tanabe Clinical Trials Information Desk 2nd Contact: Kyowa Hakko Kogyo Clinical Trials Information Desk email: