Lower-Dose stroke drug shows promise in japanese trial
NCT ID NCT00147316
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a lower dose (0.6 mg/kg) of the clot-busting drug alteplase in 103 Japanese patients who had a stroke within the previous 3 hours. The goal was to see if this dose was both safe and effective for this population. Results focused on how many patients had little to no disability after 3 months and how many had bleeding in the brain as a side effect.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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103 people
The number who actually took part.
- Start date
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Apr 2002
- Completion date
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Sep 2003
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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National Cardiovascular Center
Suita, Osaka, 565-8565, Japan
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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