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

StatusCompleted
PhasePhase 4
Started

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Record History

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  1. Re-verified, no change to tracked fieldsv17
  2. Secondary endpoints revised (3)v16
  3. Secondary endpoints: details revised at 2 of 3 entriesv15
  4. Study sites: 0 to 1v14
  5. Re-verified, no change to tracked fieldsv13
Show 11 earlier versionsHide 11 earlier versions
  1. Primary endpoints revised (3)v12
  2. Results first posted: Feb 24, 2012v11 Show 4 more changesShow less
    • Primary endpoints revised (3)
    • Secondary endpoints revised (3)
    • Publications: 1 to 2
    • Study arms: 0 to 1
  3. Study Identification, Study Statusv10
  4. Trial status: Recruiting to Completedv9 Show 4 more changesShow less
    • 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
    • Collaborator revised
  5. Re-verified, no change to tracked fieldsv8
  6. Study title expanded, about 6 wordsv7
  7. 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
    v6
  8. Re-verified, no change to tracked fieldsv5
  9. 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
    v4
  10. Interventions: Alteplase (Tissue Plasminogen Activator, GRTPA, ACTIVACIN) (Drug) to Tissue Plasminogen Activator(Alteplase)(GRTPA, ACTIVACIN) (Drug)v3
  11. Interventions: Tissue Plasminogen Activator (GRTPA, ACTIVACIN) (Drug) to Alteplase (Tissue Plasminogen Activator, GRTPA, ACTIVACIN) (Drug)
    • Eligibility criteria expanded, about 8 words
    v2
  1. Study First Submitted
  • 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
(from sponsor)		 Stroke
Related terms Brain Ischemia, Cerebral Infarction, Ischemic Stroke, Stroke
Enrollment 58 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov