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

January 14, 2023 updated by: National Society for Neurosonology and Cerebral Circulation

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

336

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Tatiana Kharitonova
  • Phone Number: +79217450431
  • Email: tvh2001@mail.ru

Study Locations

  • Russian Federation
      • Saint-Petersburg, Russian Federation
        • St. Petersburg Research Institute of Emergency Medicine named after I.I. Janelidze
        • Contact:
          • Ekaterina Gogoleva

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
36 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2023

Primary Completion (Anticipated)

February 1, 2024

Study Completion (Anticipated)

May 10, 2024

Study Registration Dates

First Submitted

January 14, 2023

First Submitted That Met QC Criteria

January 14, 2023

First Posted (Estimate)

January 26, 2023

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 14, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REPIN-Forte

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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