Japan Alteplase Clinical Trial (J-ACT): Efficacy and Safety Study of Tissue Plasminogen Activator (Alteplase) for Ischemic Stroke
1 other identifier
interventional
103
1 country
1
Brief Summary
Based on previous studies comparing Duteplase\[a recombinant tissue plasminogen activator (rt-PA) very similar to alteplase\] doses, we performed a clinical trial with 0.6mg/kg, which is lower than the internationally approved dosage of 0.9mg/kg, aiming to assess the efficacy and safety of alteplase for the Japanese.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2002
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 5, 2005
CompletedFirst Posted
Study publicly available on registry
September 7, 2005
CompletedResults Posted
Study results publicly available
February 24, 2012
CompletedJanuary 5, 2026
December 1, 2025
September 5, 2005
January 19, 2012
December 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Patients With a Modified Rankin Scale (mRS) Score of 0-1 at 3 Months
The number of patients with a 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.
at 3 months
Number of Patients With Symptomatic Intracranial Hemorrhage (sICH) Within 36 Hours
The number of patients with sICH
within 36 hours
Study Arms (1)
Alteplase
EXPERIMENTAL0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
Interventions
0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
Eligibility Criteria
You may qualify if:
- Patients with acute ischemic stroke within 3 hours of onset, with a clearly defined time of onset
You may not qualify if:
- 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
- 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)
- CT evidence of cerebral hemorrhage or subarachnoid hemorrhage
- symptoms suggestive of subarachnoid hemorrhage
- lactation, pregnancy or suggestive pregnancy; menstruation
- platelet count below 100,000/mm3
- 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
- major surgery or serious trauma within the preceding 14 days; serious head or spinal cord trauma within the preceding 3 months
- a history of gastrointestinal or urinary tract hemorrhage within the previous 21 days
- arterial puncture at a noncompressible site within the preceding 7 days
- 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.
- concurrent severe hepatic or renal dysfunction
- malignant tumor under treatment
- a systolic blood pressure of \>185 mmHg or diastolic blood pressure of \>110 mmHg
- a need for aggressive treatment to reduce blood pressure to below these limits(14))
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tanabe Pharma Corporationlead
- Kyowa Hakko Kogyo Co., Ltd.collaborator
Study Sites (1)
National Cardiovascular Center
Suita, Osaka, 565-8565, Japan
Related Publications (2)
Yamaguchi T, Mori E, Minematsu K, Nakagawara J, Hashi K, Saito I, Shinohara Y; Japan Alteplase Clinical Trial (J-ACT) Group. Alteplase at 0.6 mg/kg for acute ischemic stroke within 3 hours of onset: Japan Alteplase Clinical Trial (J-ACT). Stroke. 2006 Jul;37(7):1810-5. doi: 10.1161/01.STR.0000227191.01792.e3. Epub 2006 Jun 8.
PMID: 16763187RESULTHirano T, Sasaki M, Tomura N, Ito Y, Kobayashi S; Japan Alteplase Clinical Trial Group. Low Alberta stroke program early computed tomography score within 3 hours of onset predicts subsequent symptomatic intracranial hemorrhage in patients treated with 0.6 mg/kg Alteplase. J Stroke Cerebrovasc Dis. 2012 Nov;21(8):898-902. doi: 10.1016/j.jstrokecerebrovasdis.2011.05.018. Epub 2011 Jul 7.
PMID: 21737309DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trials, Information Desk
- Organization
- Tanabe Pharma Corporation
Study Officials
- STUDY CHAIR
Takenori Yamaguchi, MD
National Cerebral and Cardiovascular Center, Japan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 5, 2005
First Posted
September 7, 2005
Study Start
April 1, 2002
Study Completion
September 1, 2003
Last Updated
January 5, 2026
Results First Posted
February 24, 2012
Record last verified: 2025-12