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Single Bolus Non-immunogenic Staphylokinase in Patients With Acute Ischemic Stroke Within 4.5-24 Hours of Symptom Onset

NCT07324837 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 990

Last updated 2026-01-08

No results posted yet for this study

Summary

Multicenter, double-blind, randomized, placebo-controlled phase III clinical trial. At the clinical sites, patients with acute ischemic stroke within 4.5-24 hours of symptom onset will be randomized to receive a single bolus injection of the recombinant non-immunogenic staphylokinase (Fortelyzin®, LLC "SuperGene", Russia) or placebo.

Conditions

  • Ischemic Stroke, Acute

Interventions

DRUG

non-immunogenic staphylokinase

The non-immunogenic staphylokinase is given as a single intravenous bolus, 10 mg (within 5-10 seconds) immediately upon randomization regardless patient's bodyweight

DRUG

Placebo

Placebo is given as a single intravenous bolus (within 5-10 seconds) immediately upon randomization

Sponsors & Collaborators

  • Supergene, LLC

    lead INDUSTRY

Principal Investigators

  • Nikolay A. Shamalov, MD, prof · Federal Center for Brain and Neurotechnology of the Federal Medical and Biological Agency of Russia

  • Sergey S. Markin, MD, prof · LLC "SuperGene"

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2028-11-01
Completion
2029-01-01

Countries

  • Russia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07324837 on ClinicalTrials.gov