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

StatusCompleted
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Minor

    Study Status, More Information

    Re-verified, no change to tracked fields

    v17

  2. Minor

    Secondary endpoints revised (3)

    Show what changed: Secondary endpoints
    SafetyPercentage of Participants With Adverse Events and Adverse Drug Reactions

    Study Status, Outcome Measures, Outcome Measures (Results)v16

  3. Minor

    Secondary endpoints: details revised at 2 of 3 entries

    Study Status, Outcome Measures, Outcome Measures (Results)v15

  4. Minor

    Study sites: 0 to 1

    Study Status, Contacts/Locations, Baseline Characteristics, Outcome Measures (Results)v14

  5. Minor

    Study Status

    Re-verified, no change to tracked fields

    v13

Show 11 earlier versions

  1. Notable

    Primary endpoints revised (3)

    Show what changed: Primary endpoints
    The IncidenceNumber of Patients With Symptomatic Intracranial Hemorrhage (sICH) Within 36 Hours TheNumber Rateof Patients With Valid Recanalization Assessed by Magnetic Resonance Angiography (MRA) Number of Patients With a Modified Rankin Scale (mRS) Score of 0-1 (Favorablea Outcome) The3 Rate of Recanalization Assessed by MR AngiographyMonths

    Study Status, Outcome Measures, Outcome Measures (Results)v12

  2. Notable

    Results first posted: Feb 24, 2012

    Primary endpoints revised (3); Secondary endpoints revised (3); 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 (3)
      Show what changed
      The incidenceIncidence of symptomaticSymptomatic intracranialIntracranial hemorrhageHemorrhage (sICH) The rateRate of patientsPatients withWith a mRS scoreScore of 0-1 (Favorable Outcome) The rateRate of recanalizationRecanalization assessedAssessed by MRAMR Angiography
    • Minor Secondary endpoints revised (3)
      Show what changed
      National Institutes of Health Stroke Scale (NIHSS) scoreScore
    • Minor Publications: 1 to 2
      Show what changed
      Mori E, Minematsu K, Nakagawara J, Yamaguchi T, Sasaki M, Hirano T; Japan Alteplase Clinical Trial II Group. 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). Stroke. 2010 Mar;41(3):461-5. d [...]
    • Minor Study arms: 0 to 1

    Study Status, Sponsor/Collaborators, Arms and Interventions, Outcome Measures, References, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Informationv11

  3. Minor

    Study Identification, Study Status

    v10

  4. Minor

    Trial status: Recruiting to Completed

    Enrollment target: estimated 50 to confirmed 58; Study sites: 1 to 0; Primary and study completion dates changed from estimate of Dec 2008 to Jun 2008; and 1 more

    Show all 5 changes in this update
    • Minor Trial status: Recruiting to Completed
    • Minor Enrollment target: estimated 50 to confirmed 58
    • Minor Study sites: 1 to 0
    • Minor Primary and study completion dates changed from estimate of Dec 2008 to Jun 2008
    • Minor Collaborator revised
      Show what changed
      Kyowa Hakko KogyoKirin Co., Ltd.

    Study Status, Sponsor/Collaborators, Study Design, Contacts/Locationsv9

  5. Minor

    Study Status, Contacts/Locations

    Re-verified, no change to tracked fields

    v8

  6. Minor

    Study title expanded, about 6 words

    Show what changed: Study title
    Post-Marketing Clinical Study of Alteplase for Acute Ischemic Stroke （Japan Alteplase Clinical Trial Ⅱ：J-ACT Ⅱ）

    Study Identification, Study Statusv7

  7. Minor

    Primary and study completion dates: Dec 2008

    Interventions: Tissue Plasminogen Activator (Alteplase)(GRTPA, ACTIVACIN) (Drug) to Alteplase (Drug); Secondary endpoints: details revised at 3 of 3 entries

    Study Status, Sponsor/Collaborators, Oversight, Study Description, Arms and Interventions, Outcome Measures, Contacts/Locationsv6

  8. Minor

    Study Status, Study Design

    Re-verified, no change to tracked fields

    v5

  9. Notable

    Primary endpoints: 1 to 3

    Interventions: Tissue Plasminogen Activator(Alteplase)(GRTPA, ACTIVACIN) (Drug) to Tissue Plasminogen Activator (Alteplase)(GRTPA, ACTIVACIN) (Drug); Eligibility criteria expanded, about 29 words; Secondary endpoints: 1 to 3

    Show what changed: Primary endpoints
    The rateincidence of recanalizationsymptomatic assessedintracranial byhemorrhage MRA : (sICH) The rate of patients with a mRS score of 0-1 : The incidencerate of symptomaticrecanalization intracranialassessed hemorrhageby (sICH)MRA
    Show what changed: Eligibility criteria
    [...] arly defined time of onset. Patients who have been revealed to have occlusion in theon one side of the middle cerebral artery (M1 or M2 portion) on MRA before the start of treatment. Patients whosefor whom consent ishas been obtained from either themselves or from their legally acceptable representatives in written form. Exclusion Criteria: Patients with highlyvery light neurological symptoms (an NIHSS score of <= 4) or wit [...] fore stroke onset. Patients who have been administered drugs that are not allowed to be administered concomitantly with alteplase [...] e early ischemic change (an Alberta Stroke P [...]
    Show what changed: Secondary endpoints
    National Institutes of Health Stroke Scale (NIHSS) score : Barthel Index (BI) : Safety, etc.

    Study Identification, Study Status, Conditions, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locationsv4

  10. Minor

    Interventions: Alteplase (Tissue Plasminogen Activator, GRTPA, ACTIVACIN) (Drug) to Tissue Plasminogen Activator(Alteplase)(GRTPA, ACTIVACIN) (Drug)

    Study Status, Arms and Interventions, Contacts/Locationsv3

  11. Minor

    Interventions: Tissue Plasminogen Activator (GRTPA, ACTIVACIN) (Drug) to Alteplase (Tissue Plasminogen Activator, GRTPA, ACTIVACIN) (Drug)

    Eligibility criteria expanded, about 8 words

    Show what changed: Eligibility criteria
    [...] nts) after the stroke onset. Patients who have been revealed to have extensive early ischemic change (an Alberta Stroke Program [...] raphy (CT) before treatment. Patients who have been revealed to have obvious occlusion in the blood vessel except middle cerebra [...] s who are forbidden to undergo MRI. Patients who are defined to have cerebral hemorrhage or subarachnoid hemorrhage (SAH) on CT [...] emorrhage (gastrointestinal hemorrhage, urinary hemorrhage, retroperitoneulretroperitoneal hemorrhage, hemoptysis). Patients with a platelet count below 100,000/mm3. Patients with fasting blo [...] s who have a history of o [...]

    Study Status, Study Description, Arms and Interventions, Eligibilityv2

  1. 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.
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.
Trial Details
NCT Number NCT00412867
Lead Sponsor Tanabe Pharma Corporation
Collaborators: Kyowa Kirin Co., Ltd.
Conditions Stroke
Enrollment 58 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov