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NCT Number: NCT05697575

Non-immunogenic 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.

Recruiting

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Key information

Conditions

Acute Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Saint Petersburg, Russia

Location status: Recruiting

Location contact

Ekaterina Gogoleva

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Tatiana Kharitonova

CONTACT

[email protected]

+79217450431

Sponsors and collaborators

Lead sponsor

National Society for Neurosonology and Cerebral Circulation

Other

Registry information

Official study 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

Acronym: REPIN

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Jan 26, 2023
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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