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

Completed

Phase 4 Results

Trial Description

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 literature.

Conditions

Interventions

  • Alteplase Drug
    Intervention Desc: 0.6 mg/kg of Alteplase is intravenously administered
    ARM 1: Kind: Experimental
    Label: Alteplase
    Description: 0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour

Trial Design

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

Patient Involvement

Patients will have baseline magnetic resonance angiography (MRA), mRS, NIHSS, and Barthel Index. After baseline workup given altepase. At 3 months repeat mRS, NIHSS, and Barthel Index.

Outcomes

Type Measure Time Frame Safety Issue
Primary The rate of recanalization assessed by MRA; the rate of patients with a mRS score of 0-1; the incidence of symptomatic intracranial hemorrhage (sICH).
Secondary National Institutes of Health Stroke Scale (NIHSS) score; Barthel Index (BI); safety.
Primary The rate of recanalization assessed by MRA within 6 hours, from 24 to 36 hours after onset No
Primary The rate of patients with a mRS score of 0-1 3 months after onset No
Primary The incidence of symptomatic intracranial hemorrhage (sICH) within 36 hours after starting treatment Yes
Secondary National Institutes of Health Stroke Scale (NIHSS) score within 6 hours, from 24 to 36 hours, 3 months after onset, etc. No
Secondary Barthel Index (BI) the day of discharge within 3 months after onset, and 3 months after onset Yes
Secondary Safety 3 months Yes
Primary The Rate of Recanalization Assessed by MR Angiography within 6 hours, from 24 to 36 hours after onset No
Primary The Rate of Patients With a mRS Score of 0-1 (Favorable Outcome) 3 months after onset No
Primary Number of Patients With Valid Recanalization Assessed by Magnetic Resonance Angiography (MRA) within 6 hours, from 24 to 36 hours after onset No
Primary Number of Patients With a Modified Rankin Scale (mRS) Score of 0-1 a 3 Months 3 months after onset No
Primary Number of Patients With Symptomatic Intracranial Hemorrhage (sICH) Within 36 Hours within 36 hours after starting treatment No

Sponsors