Post-marketing Clinical Study of Alteplase for Acute Ischemic Stroke （Japan Alteplase Clinical Tr… (NCT00412867) | Clinical Trial Compass
CompletedPhase 4
Post-marketing Clinical Study of Alteplase for Acute Ischemic Stroke （Japan Alteplase Clinical Trial Ⅱ：J-ACT Ⅱ）
Japan58 participantsStarted 2006-12
Plain-language summary
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.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with acute ischemic stroke within 3 hours of onset, with a clearly defined time of onset.
* Patients who have been revealed to have occlusion on one side of the middle cerebral artery (M1 or M2 portion) on MRA before the start of treatment.
* Patients for whom consent has been obtained from either themselves or from their legally acceptable representatives in written form.
Exclusion Criteria:
* Patients with very light neurological symptoms (an NIHSS score of \<= 4) or with rapidly improving symptoms before the start of treatment.
* Patients with serious neurological disorders (an NIHSS score of \>= 23), or serious consciousness disorders (a Japan Coma Scale score of \>= 100) before the start of treatment.
* Patients with functional disorders (a mRS score of \>= 2) before stroke onset.
* Patients who have been administered drugs that are not allowed to be administered concomitantly with alteplase (other thrombolytic agents) after the stroke onset.
* Patients who have been revealed to have extensive early ischemic change (an Alberta Stroke Program Early CT score of \<= 6) on computed tomography (CT) before treatment.
* Patients who have been revealed to have obvious occlusion in the blood vessel except for the middle cerebral artery on MRA before treatment.
* Patients who are forbidden to undergo magnetic resonance imaging (MRI).
* Patients who are defined as having cerebral hemorrhage or subarachnoid hemorrhage (SAH) on CT before treatment.
*…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Patients With Valid Recanalization Assessed by Magnetic Resonance Angiography (MRA)
Timeframe: within 6 hours, from 24 to 36 hours after onset
2
Number of Patients With a Modified Rankin Scale (mRS) Score of 0-1 a 3 Months
Timeframe: 3 months after onset
3
Number of Patients With Symptomatic Intracranial Hemorrhage (sICH) Within 36 Hours
Timeframe: within 36 hours after starting treatment