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

Amendment history

1. Dec 15, 2025

   Minor

   Study Status, Baseline Characteristics, More Information

   Re-verified, no change to tracked fields

   v4

2. Feb 29, 2012

   Notable

   Primary endpoints revised (2)

   Interventions: alteplase (Drug) to Alteplase (Drug); Eligibility criteria expanded, about 7 words; Study description shortened, about 1 word; and 2 more

   Show all 6 changes in this update

   • Notable Primary endpoints revised (2)
     Show what changed

     FavorableNumber Outcomeof Patients With Symptomatic Intracranial Hemorrhage (sICH) Within 36 Hours Number of Patients With a Modified Rankin Scale (mRS) Score of 0-1 at 3 Months Symptomatic Intracranial Hemorrhage Within 36 Hours
   • Minor Interventions: alteplase (Drug) to Alteplase (Drug)
   • Minor Eligibility criteria expanded, about 7 words
     Show what changed

     [...] g neurological symptoms or with minor neurological deficit (anNational Institutes of Health Stroke Scale (NIHSS) score of ≤4) prior to the start of treatment Computed Tomography (CT) evidence of non-minor early ischemic signs (minor early isc [...]
   • Minor Study description shortened, about 1 word
     Show what changed

     Based on previous studies comparing differentDuteplase ( an rt-PA very similar to alteplase) doses, we performed a clinical trial with 0.6mg/kg, which i [...] anese. The primary endpoints were the rate of patients with a modified Rankin Scale (mRS) score of 0-1 at 3 months and the incidence of symptomatic intracranial hemorrhage (sICH) within 36 hours. Thresholds for these endpoints were determ [...]
   • Minor Publications: details revised at 1 of 2 entries
   • Minor Study title expanded, about 2 words
     Show what changed

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

   Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, References, Outcome Measures (Results) · v3

3. Jan 19, 2012

   Notable

   Results first posted: Feb 24, 2012

   Primary endpoints revised (2); Enrollment target: 100 to 103; Publications: 1 to 2; and 1 more

   Show all 5 changes in this update

   • Notable Results first posted: Feb 24, 2012
   • Notable Primary endpoints revised (2)
     Show what changed

     TheFavorable incidence of symptomatic intracranial hemorrhage within 36 hours The rate of patients with a modified Rankin Scale score of 0-1Outcome at 3 monthsMonths Symptomatic Intracranial Hemorrhage Within 36 Hours
   • Minor Enrollment target: 100 to 103
   • Minor Publications: 1 to 2
     Show what changed

     Yamaguchi T, Mori E, Minematsu K, Nakagawara J, Hashi K, Saito I, Shinohara Y; Japan Alteplase Clinical Trial (J-ACT) Group. Alteplase at 0.6 mg/kg for acute ischemic stroke within 3 hours of onset: Japan Alteplase Clinical Trial (J-ACT). Stroke. 2006 Jul;37(7):1810-5. doi: 10.1161/01.STR.0000227191 [...]
   • Minor Study arms: 0 to 1

   Study Status, Study Design, Arms and Interventions, Outcome Measures, References, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information · v2

4. Sep 5, 2005

   Minor

   Study First Submitted

• Stopped: an ongoing trial was terminated, suspended or withdrawn.
• Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
• Minor: routine progress and housekeeping, such as sites added or enrollment closed.