Post-marketing Clinical Study of Alteplase for Acute Ischemic Stroke （Japan Alteplase Clinical Trial Ⅱ：J-ACT Ⅱ）
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|ClinicalTrials.gov Identifier: NCT00412867|
Recruitment Status : Completed
First Posted : December 19, 2006
Results First Posted : February 24, 2012
Last Update Posted : January 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Drug: Alteplase||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Post-marketing Clinical Study of Alteplase for Acute Ischemic Stroke (Phase 4)|
|Study Start Date :||December 2006|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||June 2008|
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
- Number of Patients With Valid Recanalization Assessed by Magnetic Resonance Angiography (MRA) [ Time Frame: within 6 hours, from 24 to 36 hours after onset ]
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 ]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 ]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. ]from 0 (normal) to 40 (most severe)
- Barthel Index (BI) [ Time Frame: the day of discharge within 3 months after onset, and 3 months after onset ]from 100 (Independent) to 0 (full assistance)
- Percentage of Participants With Adverse Events and Adverse Drug Reactions [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00412867
|Investigational site 01|
|Study Chair:||Takenori Yamaguchi, M.D.||National Cerebral and Cardiovascular Center|