Post-marketing Clinical Study of Alteplase for Acute Ischemic Stroke （Japan Alteplase Clinical Trial Ⅱ：J-ACT Ⅱ）
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Post-marketing Clinical Study of Alteplase for Acute Ischemic Stroke (Phase 4)|
- Number of Patients With Valid Recanalization Assessed by Magnetic Resonance Angiography (MRA) [ Time Frame: within 6 hours, from 24 to 36 hours after onset ] [ Designated as safety issue: No ]
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.
- Number of Patients With a Modified Rankin Scale (mRS) Score of 0-1 a 3 Months [ Time Frame: 3 months after onset ] [ Designated as safety issue: No ]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.
- Number of Patients With Symptomatic Intracranial Hemorrhage (sICH) Within 36 Hours [ Time Frame: within 36 hours after starting treatment ] [ Designated as safety issue: No ]The number of patients with sICH
- National Institutes of Health Stroke Scale (NIHSS) Score [ Time Frame: within 6 hours, from 24 to 36 hours, 3 months after onset, etc. ] [ Designated as safety issue: No ]
- Barthel Index (BI) [ Time Frame: the day of discharge within 3 months after onset, and 3 months after onset ] [ Designated as safety issue: No ]
- Safety [ Time Frame: 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||December 2006|
|Study Completion Date:||June 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
0.6 mg/kg of Alteplase is intravenously administered