Non-immunogenic Staphylokinase in Reperfusion Therapy of Ischemic Stroke in Routine Clinical Practice

Non-interventional Observational Study to Evaluate the Efficacy and Safety of Non-immune Staphylokinase in Reperfusion Therapy of Ischemic Stroke in Routine Clinical Practice

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05697575

Acronym

REPIN

Enrollment

336

Registered

2023-01-26

Start date

2023-02-01

Completion date

2030-05-10

Last updated

2026-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Stroke

Keywords

stroke thrombolysis, acute ischemic stroke, reperfusion

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Proportion of intracerebral hemorrhage	36 hours	Number and proportion of intracerebral bleeding of any type, which occurs as a complication of thrombolytic treatment

Countries

Russia

Contacts

CONTACTTatiana Kharitonova

tvh2001@mail.ru+79217450431

STUDY_DIRECTORIgor A Voznjuk, Prof

First St. Petersburg State Medical University named after I.P. Pavlov

Outcome results