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

Acute Stroke Clinical Trial

— REPIN  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05697575
• Other study ID #: REPIN-Forte
• Status: Recruiting
• Start date: February 1, 2023
• Est. completion date: May 10, 2024

Study information

• Verified date: February 2023
• Source: National Society for Neurosonology and Cerebral Circulation
• Contact: Tatiana Kharitonova
• Phone: +79217450431
• Email: tvh2001[@]mail.ru
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 336
• Est. completion date: May 10, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Stroke
• Ischemic Stroke
• Stroke

Locations

Country	Name	City	State
Russian Federation	St. Petersburg Research Institute of Emergency Medicine named after I.I. Janelidze	Saint-Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
National Society for Neurosonology and Cerebral Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

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