At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 58 enrolled
Drug / intervention
Alteplasedrug
Likely dose
Alteplase 0.6 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Post-marketing Clinical Study of Alteplase for Acute Ischemic Stroke (Phase 4)
In Brief
A Phase 4 clinical trial evaluating Alteplase for Stroke. Completed, enrolled 58 participants across 1 site.
Detailed Summary
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 Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke
CountriesJapan
CollaboratorsKyowa Kirin Co., Ltd.
Timeline
Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2006
First PostedDec 2006
Primary CompletionJun 2008
TodayJul 2026
First PostedDec 19, 2006
Enrollment StartDec 1, 2006
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 19.5 years ago
Interventions
Alteplasedrug
0.6 mg/kg of Alteplase is intravenously administered