Status:
COMPLETED
Japan Alteplase Clinical Trial (J-ACT): Efficacy and Safety Study of Tissue Plasminogen Activator (Alteplase) for Ischemic Stroke
Lead Sponsor:
Tanabe Pharma Corporation
Collaborating Sponsors:
Kyowa Hakko Kogyo Co., Ltd.
Conditions:
Cerebral Infarction
Brain Ischemia
Eligibility:
All Genders
20+ years
Phase:
PHASE3
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 th...
Detailed Description
Based on previous studies comparing Duteplase ( an 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...
Eligibility Criteria
Inclusion
- Patients with acute ischemic stroke within 3 hours of onset, with a clearly defined time of onset
Exclusion
- 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))
- blood glucose levels of \<50 mg/dL or \>400 mg/dL
- acute myocardial infarction(AMI) or endocarditis after AMI
- 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
- seizure at the onset of stroke
- coma (a Japan Coma Scale score of ≥100)
- an mRS score of ≥2 before stroke onset
- a history of hypersensitivity to protein preparations
- difficulty in monitoring for 3 months
- less than 3 months since any other clinical trial
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2003
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT00147316
Start Date
April 1 2002
End Date
September 1 2003
Last Update
January 5 2026
Active Locations (1)
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1
National Cardiovascular Center
Suita, Osaka, Japan, 565-8565