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Lower-Dose stroke drug shows promise in japanese trial

NCT ID NCT00147316

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

103 people

The number who actually took part.

Start date

Apr 2002

Completion date

Sep 2003

Lead sponsor

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

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

  • National Cardiovascular Center

    Suita, Osaka, 565-8565, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.