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

Recruiting

• Conditions: Acute Stroke

• Registration Number: NCT05697575
• Lead Sponsor: National Society for Neurosonology and Cerebral Circulation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-14
• Study First Submitted QC: 2023-01-14
• Study First Posted: 2023-01-26
• Status Verified: 2023-02
• Study Start: 2023-02-01
• Last Update Submitted: 2023-02-01
• Last Update Posted: 2023-02-03
• Primary Completion: 2024-02-01
• Study Completion: 2024-05-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 336

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

St. Petersburg Research Institute of Emergency Medicine named after I.I. Janelidze; 🇷🇺 Saint-Petersburg, Russian Federation