Using non-immunogenic staphylokinase to restore blood flow after ischemic stroke
Non-interventional Observational Study to Evaluate the Efficacy and Safety of Non-immune Staphylokinase in Reperfusion Therapy of Ischemic Stroke in Routine Clinical Practice
This will test whether a new clot-busting drug called non-immunogenic staphylokinase is safe and works as well as alteplase for adults 18–85 treated for acute ischemic stroke.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 336 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | National Society for Neurosonology and Cerebral Circulation Academic / other |
| Locations | 1 site (Saint Petersburg) |
| Trial ID | NCT05697575 on ClinicalTrials.gov |
What this trial studies
This observational project will collect clinical data from adults aged 18–85 with acute ischemic stroke who receive thrombolytic treatment with non-immunogenic staphylokinase in routine practice. Safety outcomes and clinical recovery measures will be recorded and compared to results from patients treated with the standard thrombolytic alteplase. Patients with known hypersensitivity to staphylokinase sequences, contraindications to thrombolysis, or who are pregnant or breastfeeding are excluded. Data collection occurs at the participating clinical site(s) and focuses on real-world effectiveness and adverse events following reperfusion therapy.
Who should consider this trial
Good fit: Adults aged 18–85 with acute ischemic stroke who are eligible for thrombolytic therapy and who are planned to receive or have received non-immunogenic staphylokinase.
Not a fit: Patients with known hypersensitivity to staphylokinase sequences, contraindications to thrombolysis, pregnant or breastfeeding individuals, or those with hemorrhagic stroke are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could provide a clot-busting option with lower immune reactions that is as effective as alteplase, potentially improving safety and treatment choices.
How similar studies have performed: Previous work with staphylokinase showed thrombolytic activity but was limited by immunogenicity, and non-immunogenic versions are a newer approach with limited real-world evidence so far.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-85 ; * Diagnosis of acute ischemic stroke eligible for thrombolytic therapy; * Thrombolytic therapy with the drug "non-immunogenic staphylokinase" is planned or has already been performed. Exclusion Criteria: * Individual intolerance or known hypersensitivity to a recombinant protein containing the amino acid sequence of staphylokinase; * The presence of a contraindication to thrombolytic therapy of ischemic stroke; * Pregnancy or lactation.
Where this trial is running
Saint Petersburg
- St. Petersburg Research Institute of Emergency Medicine named after I.I. Janelidze — Saint Petersburg, Russia (Recruiting)
Study contacts
- Study coordinator: Tatiana Kharitonova
- Email: tvh2001@mail.ru
- Phone: +79217450431
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.