Non-immunogenic Staphylokinase in Reperfusion Therapy of Ischemic Stroke in Routine Clinical Practice
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Acute Stroke. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Non-interventional Observational Study to Evaluate the Efficacy and Safety of Non-immune Staphylokinase in Reperfusion Therapy of Ischemic Stroke in Routine Clinical Practice
Overview
The study will collect data from aged 18 to 85 years with a diagnosis of acute stroke, who received thrombolytic treatment with a new agent, nonimmunogenic staphylokinase. Outcomes will be checked for safety and compared to the results of treatment with the other thrombolytic drug, alteplase.
Primary outcome measures
- Proportion of intracerebral hemorrhage [Time frame: 36 hours]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Russia · 1 center
- St. Petersburg Research Institute of Emergency Medicine named after I.I. Janelidze — Saint Petersburg
Identifiers
NCT: NCT05697575 · REPIN-Forte