At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 336 enrolled
Drug / intervention
Recombinant staphylokinase +1 moredrug
Likely dose
Recombinant staphylokinase 10 mgfrom 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.
Multicenter Open Label Randomized Comparative Study of Efficacy and Safety of Single Bolus Injection of Recombinant Nonimmunogenic Staphylokinase (Fortelyzin) and Bolus Infusion Alteplase (Actilyse) in Patients With Acute Ischemic Stroke
In Brief
A Phase 3 clinical trial evaluating Recombinant staphylokinase and Alteplase for Ischemic Stroke. Completed, enrolled 336 participants across 18 sites.
Detailed Summary
The aim of the study is to determine if single-bolus recombinant nonimmunogenic staphylokinase is effective and save thrombolytic agent in patients with ischemic stroke in comparison to alteplase.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIschemic Stroke
CountriesRussia
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartMar 2017
First PostedMay 2017
Primary CompletionMar 2019
Study CompletionJun 2019
TodayJul 2026
First PostedMay 12, 2017
Enrollment StartMar 18, 2017
Primary CompletionMar 23, 2019
Study CompletionJun 20, 2019
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 9.1 years ago
Interventions
Recombinant staphylokinasedrug
10 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds
Alteplasedrug
Intravenous alteplase 0.9 mg/kg (10% bolus and 90% as IV infusion over 1 hour, maximum 90 mg)