At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 103 enrolled
Drug / intervention
Alteplasedrug
Likely dose
0.6 mg/kg intravenous alteplase: 10% as bolus followed by 90% over 1 hourAI-extracted
Key inclusion· 1
- ✓Acute ischemic stroke within 3 hours of clearly defined onset
Key exclusion· 14
- ✕Rapidly improving neurological symptoms or minor stroke (NIHSS ≤4)
- ✕Non-minor early ischemic signs on CT (involvement >1/3 of middle cerebral artery area)
- ✕Cerebral or subarachnoid hemorrhage on CT or clinical suspicion
- ✕History of stroke within 3 months or intracranial hemorrhage
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Japan Alteplase Clinical Trial (J-ACT): Phase 3 Efficacy and Safety Study of Tissue Plasminogen Activator (Alteplase) for Acute Ischemic Stroke Within 3 Hours of Onset
In Brief
A Phase 3 clinical trial evaluating Alteplase for Cerebral Infarction and Brain Ischemia. Completed, enrolled 103 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCerebral Infarction, Brain Ischemia
CountriesJapan
CollaboratorsKyowa Hakko Kogyo Co., Ltd.
Timeline
Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2002
Study CompletionSep 2003
First PostedSep 2005
TodayJul 2026
First PostedSep 7, 2005
Enrollment StartApr 1, 2002
Study CompletionSep 1, 2003
TodayJul 2, 2026
Posted 20.8 years ago
Interventions
Alteplasedrug
0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour