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

Sponsor
National Society for Neurosonology and Cerebral Circulation (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05697575
Collaborator
(none)
336
Enrollment
1
Location
15.2
Anticipated Duration (Months)
22
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    336 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Other
    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
    Anticipated Study Start Date :
    Feb 1, 2023
    Anticipated Primary Completion Date :
    Feb 1, 2024
    Anticipated Study Completion Date :
    May 10, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of intracerebral hemorrhage [36 hours]

      Number and proportion of intracerebral bleeding of any type, which occurs as a complication of thrombolytic treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St. Petersburg Research Institute of Emergency Medicine named after I.I. Janelidze Saint-Petersburg Russian Federation

    Sponsors and Collaborators

    • National Society for Neurosonology and Cerebral Circulation

    Investigators

    • Study Director: Igor A Voznjuk, Prof, First St. Petersburg State Medical University named after I.P. Pavlov

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Society for Neurosonology and Cerebral Circulation
    ClinicalTrials.gov Identifier:
    NCT05697575
    Other Study ID Numbers:
    • REPIN-Forte
    First Posted:
    Jan 26, 2023
    Last Update Posted:
    Jan 26, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Society for Neurosonology and Cerebral Circulation
    stroke thrombolysis
    acute ischemic stroke
    reperfusion
    Additional relevant MeSH terms:
    Stroke
    Ischemic Stroke

    Study Results

    No Results Posted as of Jan 26, 2023