CClinicalTrials.gg
Sign In
CompletedNCT00412867Updated Jan 5, 2026Results posted

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

A Phase 4 interventional study of Alteplase in Stroke, sponsored by Tanabe Pharma Corporation. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-01-05.

Sponsored by Tanabe Pharma Corporation · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
58
Allocation
Non-randomized
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Stroke

Keywords

  • Cerebral Infarction
  • acute ischemic stroke
  • Brain ischemia
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 58 is above the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Tanabe Pharma Corporation is the lead sponsor of 91 studies on the registry; 1 is open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
  • 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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
58 participants (actual)

Study arms

  • Experimental
    Alteplase

    0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour

    Drug: Alteplase

Interventions

  • DrugAlteplase

    0.6 mg/kg of Alteplase is intravenously administered

    Also known as: Tissue Plasminogen Activator, GRTPA, ACTIVACIN

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 3 months after onset

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

    The number of patients with sICH

    Time frame: within 36 hours after starting treatment

Secondary outcomes

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

    from 0 (normal) to 40 (most severe)

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

  2. Barthel Index (BI)

    from 100 (Independent) to 0 (full assistance)

    Time frame: 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

    Time frame: 3 months

07

Results

Posted Feb 24, 2012

Participant flow

Participant flow — Overall Study
MilestoneAlteplase
Started58
Completed58
Not completed0

Outcome measures

PrimaryNumber 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.

Time frame:
within 6 hours, from 24 to 36 hours after onset
Reported as:
Number · participants
Number of Patients With Valid Recanalization Assessed by Magnetic Resonance Angiography (MRA)
participantsAlteplase
within 6 hours after onset30
from 24 to 36 hours after onset40
PrimaryNumber 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.

Time frame:
3 months after onset
Reported as:
Number · participants
Number of Patients With a Modified Rankin Scale (mRS) Score of 0-1 a 3 Months
participantsAlteplase
Number of Patients With a Modified Rankin Scale (mRS) Score of 0-1 a 3 Months27
PrimaryNumber of Patients With Symptomatic Intracranial Hemorrhage (sICH) Within 36 Hours

The number of patients with sICH

Time frame:
within 36 hours after starting treatment
Reported as:
Number · participants
Number of Patients With Symptomatic Intracranial Hemorrhage (sICH) Within 36 Hours
participantsAlteplase
Number of Patients With Symptomatic Intracranial Hemorrhage (sICH) Within 36 Hours0
SecondaryNational Institutes of Health Stroke Scale (NIHSS) Score

from 0 (normal) to 40 (most severe)

Time frame:
within 6 hours, from 24 to 36 hours, 3 months after onset.
Reported as:
Median · units on a scale
National Institutes of Health Stroke Scale (NIHSS) Score
units on a scaleAlteplase
within 6 hours8.5 (0 to 20)
from 24 to 36 hours7.0 (0 to 22)
3 months after onset1.5 (0 to 32)
SecondaryBarthel Index (BI)

from 100 (Independent) to 0 (full assistance)

Time frame:
the day of discharge within 3 months after onset, and 3 months after onset
Reported as:
Mean · units on a scale
Barthel Index (BI)
units on a scaleAlteplase
the day of discharge within 3 months after onset76.2 ± 32.4
3 months after onset77.8 ± 33.2
SecondaryPercentage of Participants With Adverse Events and Adverse Drug Reactions
Time frame:
3 months
Reported as:
Number · percentage of patients
Percentage of Participants With Adverse Events and Adverse Drug Reactions
percentage of patientsAlteplase
Percentage of Patients with Adverse Events96.6
Percentage of Patients with Adverse Drug Reactions41.4

Adverse events

Collected over 3 months. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Alteplase (Non-Haemorrhage)—12/58 (20.7%)51/58 (87.9%)
Alteplase (Haemorrhage)—1/58 (1.7%)25/58 (43.1%)
Most frequent serious events
Showing 10 of 12
Most frequent serious events
EventAlteplase (Non-Haemorrhage)Alteplase (Haemorrhage)
Cerebral infarctionNervous system disorders4/580/58
Cardiac failureCardiac disorders2/580/58
Sick sinus syndromeCardiac disorders2/580/58
PneumoniaInfections and infestations2/580/58
Acute left ventricular failureCardiac disorders1/580/58
Inguinal herniaGastrointestinal disorders1/580/58
MelaenaGastrointestinal disorders0/581/58
CholecystitisHepatobiliary disorders1/580/58
Septic shockInfections and infestations1/580/58
Gastric cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/580/58
Most frequent other events
Showing 10 of 51
Most frequent other events
EventAlteplase (Non-Haemorrhage)Alteplase (Haemorrhage)
ConstipationGastrointestinal disorders27/580/58
Haemorrhagic cerebral infarctionNervous system disorders0/5821/58
InsomniaPsychiatric disorders13/580/58
Hepatic function abnormalHepatobiliary disorders10/580/58
Urinary tract infectionsInfections and infestations10/580/58
DiarrhoeaGastrointestinal disorders7/580/58
Blood creatine phosphokinase increasedInvestigations7/580/58
VomitingGastrointestinal disorders6/580/58
Back painMusculoskeletal and connective tissue disorders6/580/58
Neurogenic bladderRenal and urinary disorders6/580/58

Baseline characteristics

Age, Continuous
Age, Continuous(years)Alteplase
Mean70.3 ± 11.5
Sex: Female, Male
Sex: Female, Male(Participants)Alteplase
Female23
Male35
08

Study locations

1 site
  • Investigational site 01
    Hokkaido, Japan
09

References and documents

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 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00412867
Lead sponsor
Tanabe Pharma Corporation
Collaborators
Kyowa Kirin Co., Ltd.
Responsible party
Sponsor
First posted
Dec 19, 2006
Start date
Dec 2006
Primary completion
Jun 2008
Completion
Jun 2008
Results posted
Feb 24, 2012
Last update
Jan 5, 2026

Study contacts

Takenori Yamaguchi, M.D.
study chair · National Cerebral and Cardiovascular Center, Japan

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Stroke→

Other studies from this sponsor

Tanabe Pharma Corporation

Start the discussion