NCT05697575

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
336

participants targeted

Target at P75+ for all trials

Timeline
49mo left

Started Feb 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress45%
Feb 2023May 2030

First Submitted

Initial submission to the registry

January 14, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2030

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2030

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

7 years

First QC Date

January 14, 2023

Last Update Submit

April 9, 2026

Conditions

Acute Stroke

Keywords

stroke thrombolysisacute ischemic strokereperfusion

Outcome Measures

Primary Outcomes (1)

  • Proportion of intracerebral hemorrhage

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

    36 hours

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Saint Petersburg, Russia

RECRUITING

MeSH Terms

Conditions

StrokeIschemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Igor A Voznjuk, Prof

    First St. Petersburg State Medical University named after I.P. Pavlov

    STUDY DIRECTOR

Central Study Contacts

Tatiana Kharitonova

CONTACT

+79217450431tvh2001@mail.ru

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2023

First Posted

January 26, 2023

Study Start

February 1, 2023

Primary Completion (Estimated)

February 1, 2030

Study Completion (Estimated)

May 10, 2030

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations

RU(1)