At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,412 enrolled
Drug / intervention
Injection of recombinant human tissue plasminogen kinase derivatives +1 moredrug
Likely dose
Injection of recombinant human tissue plasminogen kinase derivatives 18mgfrom 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.
A Phase III, Multicenter, Randomized, Blind Endpoint and Positive Drug Control Study of Recombinant Human Tissue Plasminogen Kinase Derivatives for Injection in the Treatment of Patients With Acute Ischemic Stroke
In Brief
A Phase 3 clinical trial evaluating Injection of recombinant human tissue plasminogen kinase derivatives and Recombinant human tissue plasminogen activator for Acute Ischemic Stroke. Completed, enrolled 1,412 participants across 78 sites.
Detailed Summary
The purpose of this study is to assess the efficacy and safety of recombinant human tissue plasminogen kinase derivatives for injection and alteplase in the treatment of patients with acute ischemic stroke within 4.5 hours.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Ischemic Stroke
CountriesChina
CollaboratorsBeijing Tiantan Hospital
Timeline
Phase 3CompletedFinished
2023202420252026
Enrollment StartMar 2022
First PostedMar 2022
Primary CompletionJun 2023
TodayJul 2026
First PostedMar 25, 2022
Enrollment StartMar 21, 2022
Primary CompletionJun 22, 2023
TodayJul 1, 2026
Enrollment to primary: 1.3 yearsPosted 4.3 years ago
Interventions
Injection of recombinant human tissue plasminogen kinase derivativesdrug
18mg/10ml/stick, provided by Angde Biotech
Recombinant human tissue plasminogen activatordrug
20mg/stick, 50mg/stick, provided by Shanghai Boehringer Ingelheim Pharmaceutical Co. Ltd.