Japan Alteplase Clinical Trial (J-ACT): Efficacy and Safety Study of Tissue Plasminogen Activator (Alteplase) for Ischemic Stroke
Condition: Cerebral Infarction; Brain Ischemia
MeSH terms: Ischemic Stroke; Cerebral Infarction; Brain Ischemia; Infarction; Ischemia
Intervention: Alteplase
Intervention description: 0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
Intervention MeSH terms: Tissue Plasminogen Activator
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 103.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: acute stroke; thrombolytic therapy; tissue plasminogen activator

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients with acute ischemic stroke within 3 hours of onset, with a clearly defined time of
        onset

        Exclusion Criteria:

          1. patients with rapidly improving neurological symptoms or with minor neurological
             deficit (National Institutes of Health Stroke Scale (NIHSS) score of ≤4) prior to the
             start of treatment

          2. Computed Tomography (CT) evidence of non-minor early ischemic signs (minor early
             ischemic sign was defined as the involvement of one-third or less of the middle
             cerebral artery area)

          3. CT evidence of cerebral hemorrhage or subarachnoid hemorrhage

          4. symptoms suggestive of subarachnoid hemorrhage

          5. lactation, pregnancy or suggestive pregnancy; menstruation

          6. platelet count below 100,000/mm3

          7. heparin administration within 48 hours preceding stroke onset with an elevated
             activated partial thromboplastin time (APTT); current use of oral anticoagulants with
             an International Normalized Ratio (INR) of ≥1.7; use of drugs not allowed to be
             administered concomitantly with alteplase (other thrombolytic agents, ozagrel sodium,
             argatroban and edaravone) prior to the study treatment

          8. major surgery or serious trauma within the preceding 14 days; serious head or spinal
             cord trauma within the preceding 3 months

          9. a history of gastrointestinal or urinary tract hemorrhage within the previous 21 days

         10. arterial puncture at a noncompressible site within the preceding 7 days

         11. a history of stroke within the preceding 3 months; a history of intracranial
             hemorrhage or increased risk of intracranial hemorrhage because of cerebral aneurysm,
             arteriovenous malformation, neoplasm, etc.

         12. concurrent severe hepatic or renal dysfunction

         13. malignant tumor under treatment

         14. a systolic blood pressure of >185 mmHg or diastolic blood pressure of >110 mmHg

         15. a need for aggressive treatment to reduce blood pressure to below these limits(14))

         16. blood glucose levels of <50 mg/dL or >400 mg/dL

         17. acute myocardial infarction(AMI) or endocarditis after AMI

         18. concurrent infectious endocarditis, moya-moya disease (Willis circle occlusion
             syndrome), aortic dissection, neck trauma, etc.; strong suspicion of ischemic
             cerebrovascular disorder caused by non-thrombotic occlusion or any other hemodynamic
             condition

         19. seizure at the onset of stroke

         20. coma (a Japan Coma Scale score of ≥100)

         21. an mRS score of ≥2 before stroke onset

         22. a history of hypersensitivity to protein preparations

         23. difficulty in monitoring for 3 months

         24. less than 3 months since any other clinical trial