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StrokePhase 4NCT00412867

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

A Phase 4 study testing Alteplase in people with Stroke, run by Tanabe Pharma Corporation at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Stroke
What is being tested?
Alteplase
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteJapan
Study dates
Dec 2006to Jun 2008
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.
  • Patients whose symptoms suggest SAH.
  • Patients with hemorrhage (gastrointestinal hemorrhage, urinary hemorrhage, retroperitoneal hemorrhage, or hemoptysis).
  • Patients with a platelet count below 100,000/mm3.
  • Patients with fasting blood glucose levels of < 50 mg/dL or > 400 mg/dL.
  • Patients whose activated partial thromboplastin time (APTT) is prolonged due to heparin administration within 48 hours before stroke onset.
  • Patients who have been administered oral anticoagulants with values of the international normalized ratio of prothrombin time (PT-INR) of > 1.7.
  • Patients who have a systolic blood pressure of > 185 mmHg or a diastolic blood pressure of > 110 mmHg.
  • Patients who need antihypertensive therapy (e.g. continuous infusion of antihypertensive drug etc.) to lower blood pressure below those limits under the preceding article.
  • Patients who have a history of intracranial hemorrhage, or who have a disease considered to increase the risk of intracranial hemorrhage such as an intracranial tumor, cerebral aneurysm, or intracranial arteriovenous malformation, etc.
  • Patients who have a history of stroke within 3 months before onset.
  • Patients who were operated on or injured their head or spinal cord within 3 months before onset.
  • Patients who have a history of gastrointestinal or urinary tract hemorrhage within 21 days before onset.
  • Patients who had a major surgery or serious trauma (except for head or spinal cord trauma) within 14 days before onset.
  • Patients who have a history of organ biopsy, arterial puncture, or lumbar puncture within 10 days before onset.
  • Patients with severe hepatic dysfunction or severe renal dysfunction.
  • Patients with acute pancreatitis.
  • Patients who had a seizure at the onset of stroke.
  • Patients who have a history of hypersensitivity to protein preparations.
  • Patients who are lactating, pregnant, probably pregnant, or menstruating.
  • Patients with malignant tumors.
  • Patients with acute myocardial infarction (AMI) or pericarditis after AMI.
  • Patients with concurrent infectious endocarditis, moyamoya disease (Willis circle occlusion syndrome), aortic dissection, or neck trauma, etc.
  • Patients with strong suspicion of ischemic cerebrovascular disorder caused by non-thrombotic occlusion or any other hemodynamic condition.
  • Patients judged to be difficult in monitoring for 3 months by their physician.
  • Patients who have participated in other clinical trials during the last 3 months.
  • In addition to the above exclusion criteria, patients judged to be inadequate to participate in this study by their physician.

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Investigational site 01

    Hokkaido

Other trials in Japan

About this study

Official title: Post-marketing Clinical Study of Alteplase for Acute Ischemic Stroke (Phase 4)

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.

Conditions
Stroke
Being tested
Alteplase
Keywords
Cerebral Infarction, acute ischemic stroke, Brain ischemia
Medical subject headings
Stroke, Cerebral Infarction, Ischemic Stroke, Brain Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlteplaseDrug

    Also called Tissue Plasminogen Activator, GRTPA, ACTIVACIN

    0.6 mg/kg of Alteplase is intravenously administered

Study groups in NCT00412867
Study groupRoleWhat they receive
AlteplaseExperimental0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
Receives: Drug: Alteplase

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Patients With Valid Recanalization Assessed by Magnetic Resonance Angiography (MRA)

    Recanalization was evaluated according to the modified Mori grade: Grade 0, no reperfusion; Grade 1, movement of thrombus not associated with any flow improvement; Grade 2, partial (branch) recanalization in <50% of the branches in the occluded-arterial territory; Grade 3, nearly complete recanalization with reperfusion in ≥50% of the branches in the occluded-arterial territory.

    The recanalization rate was estimated by regarding Grades 2 and 3 as valid recanalization.

    Measured: 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

    The number of patients with an mRS score of 0-1. The mRS has 6 items, where 0 = No symptoms at all, 1 = No significant disability despite symptoms, 2 = Slight disability, 3 = Moderate disability, 4 = Moderately severe disability, 5 = Severe disability. The higher scores reflect increased disability.

    Measured: 3 months after onset

  3. Number of Patients With Symptomatic Intracranial Hemorrhage (sICH) Within 36 Hours

    The number of patients with sICH

    Measured: within 36 hours after starting treatment

Secondary outcomes (3)

  1. National Institutes of Health Stroke Scale (NIHSS) Score

    from 0 (normal) to 40 (most severe)

    Measured: within 6 hours, from 24 to 36 hours, 3 months after onset.

  2. Barthel Index (BI)

    from 100 (Independent) to 0 (full assistance)

    Measured: the day of discharge within 3 months after onset, and 3 months after onset

  3. Percentage of Participants With Adverse Events and Adverse Drug Reactions

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2006 (estimated)
  2. Study startDec 2006
  3. Primary completionJun 2008
  4. Study completionJun 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00412867
Sponsor's protocol ID
527-0611
Status last verified
Dec 2025
First submitted
17 Dec 2006
Last updated
5 Jan 2026
Data monitoring committee
No

Publications

  • Mori E, Minematsu K, Nakagawara J, Yamaguchi T, Sasaki M, Hirano T; Japan Alteplase Clinical Trial II Group. Effects of 0.6 mg/kg intravenous alteplase on vascular and clinical outcomes in middle cerebral artery occlusion: Japan Alteplase Clinical Trial II (J-ACT II). Stroke. 2010 Mar;41(3):461-5. doi: 10.1161/STROKEAHA.109.573477. Epub 2010 Jan 14.

    PubMed 20075341

  • Hirano T, Sasaki M, Mori E, Minematsu K, Nakagawara J, Yamaguchi T; Japan Alteplase Clinical Trial II Group. Residual vessel length on magnetic resonance angiography identifies poor responders to alteplase in acute middle cerebral artery occlusion patients: exploratory analysis of the Japan Alteplase Clinical Trial II. Stroke. 2010 Dec;41(12):2828-33. doi: 10.1161/STROKEAHA.110.594333. Epub 2010 Oct 28.

    PubMed 21030700

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Alteplase in people with Stroke, run by Tanabe Pharma Corporation at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With Valid Recanalization Assessed by Magnetic Resonance Angiography (MRA) (time frame: within 6 hours, from 24 to 36 hours after onset). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00412867, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.

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