Acute StrokeREPINNCT05697575
Non-immunogenic Staphylokinase in Reperfusion Therapy of Ischemic Stroke in Routine Clinical Practice
An observational study of Acute Stroke, run by National Society for Neurosonology and Cerebral Circulation at 1 site in Russia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Stroke
- How many people
- 336 participants
- Where
- 1 siteRussia
- Study dates
- 1 Feb 2023to 10 May 2030
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Men and women aged 18 to 85 years (inclusive), who meet the inclusion criteria and do not have contraindications for thrombolysis, with a diagnosis of acute ischemic stroke.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
St. Petersburg Research Institute of Emergency Medicine named after I.I. Janelidze
Saint Petersburg
Ekaterina Gogoleva
About this study
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
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.
- Conditions
- Acute Stroke
- Keywords
- stroke thrombolysis, acute ischemic stroke, reperfusion
- Medical subject headings
- Stroke, Ischemic Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of intracerebral hemorrhage
Number and proportion of intracerebral bleeding of any type, which occurs as a complication of thrombolytic treatment
Measured: 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Feb 2023
- Primary completion1 Feb 2030 (estimated)
- Study completion10 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 336 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- National Society for Neurosonology and Cerebral Circulation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Igor A Voznjuk, Prof, Study director, First St. Petersburg State Medical University named after I.P. Pavlov
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05697575
- Sponsor's protocol ID
- REPIN-Forte
- Acronym
- REPIN
- Status last verified
- Apr 2026
- First submitted
- 14 Jan 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05697575
- Acronym / sponsor ID
- REPIN / REPIN-Forte
- Conditions
- Acute Stroke
- Keywords
- stroke thrombolysis, acute ischemic stroke, reperfusion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- National Society for Neurosonology and Cerebral CirculationUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Feb 2030 (estimated)
- Study completion
- 10 May 2030 (estimated)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women aged 18 to 85 years (inclusive), who meet the inclusion criteria and do not have contraindications for thrombolysis, with a diagnosis of acute ischemic stroke.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of intracerebral hemorrhage
Time frame: 36 hours
Number and proportion of intracerebral bleeding of any type, which occurs as a complication of thrombolytic treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Igor A Voznjuk, Prof study director
First St. Petersburg State Medical University named after I.P. Pavlov
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Stroke, run by National Society for Neurosonology and Cerebral Circulation at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tatiana Kharitonova (+79217450431, tvh2001@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of intracerebral hemorrhage (time frame: 36 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.