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

NCT ID: NCT05697575

Last Updated: 2023-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

336 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-01

Study Completion Date

2024-05-10

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Stroke

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Society for Neurosonology and Cerebral Circulation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Igor A Voznjuk, Prof

Role: STUDY_DIRECTOR

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

Locations

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St. Petersburg Research Institute of Emergency Medicine named after I.I. Janelidze

Saint Petersburg, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Tatiana Kharitonova

Role: CONTACT

+79217450431

Facility Contacts

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Ekaterina Gogoleva

Role: primary

Other Identifiers

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REPIN-Forte

Identifier Type: -

Identifier Source: org_study_id

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