Japan Alteplase Clinical Trial (J-ACT): Efficacy and Safety Study of Tissue Plasminogen Activator (Alteplase) for Ischemic Stroke

Completed

Phase 3 Results

Trial Description

Based on previous studies comparing Duteplase[a recombinant tissue plasminogen activator (rt-PA) very similar to alteplase] doses, we performed a clinical trial with 0.6mg/kg, which is lower than the internationally approved dosage of 0.9mg/kg, aiming to assess the efficacy and safety of alteplase for the Japanese.

Detailed Description

Based on previous studies comparing Duteplase ( an rt-PA very similar to alteplase) doses, we performed a clinical trial with 0.6mg/kg, which is lower than the internationally approved dosage of 0.9mg/kg, aiming to assess the efficacy and safety of alteplase for the Japanese.
The primary endpoints were the rate of patients with mRS score of 0-1 at 3 months and the incidence of sICH within 36 hours. Thresholds for these endpoints were determined by calculating 90% confidence intervals of weighted averages derived from published reports. The protocol was defined according to the National Institute of Neurological Disorders and Stroke (NINDS) rt-PA stroke study with slight modifications.

Conditions

Interventions

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

Patient will be on altepase 0.6mg/kg. Patients will be observed for the incidence of symptomatic intracranial hemorrhage within 36 hours. Patients will have mRS at 3 months.

Outcomes

Type Measure Time Frame Safety Issue
Primary The rate of patients with a modified Rankin Scale score of 0-1 at 3 months; The incidence of symptomatic intracranial hemorrhage within 36 hours.
Primary The rate of patients with a modified Rankin Scale score of 0-1 at 3 months
Primary The incidence of symptomatic intracranial hemorrhage within 36 hours
Primary Favorable Outcome at 3 Months at 3 months No
Primary Symptomatic Intracranial Hemorrhage Within 36 Hours within 36 hours No
Primary Number of Patients With a Modified Rankin Scale (mRS) Score of 0-1 at 3 Months at 3 months No
Primary Number of Patients With Symptomatic Intracranial Hemorrhage (sICH) Within 36 Hours within 36 hours No

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