NCT05697575RecruitingNot Applicable
Non-interventional Observational Study to Evaluate the Efficacy and Safety of Non-immune Staphylokinase in Reperfusion Therapy of Ischemic Stroke in Routine Clinical Practice
National Society for Neurosonology and Cerebral Circulation2 sites in 2 countries336 target enrollmentStarted: February 1, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 336
- Locations
- 2
- Primary Endpoint
- Proportion of intracerebral hemorrhage
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Completed
Not Applicable
A Prospective Study of the Disease Characteristics of Adult Patients With Long Chain Fatty Acid Oxidation DisordersFatty Acid Oxidation DisorderNCT04482049Reneo Pharma Ltd61
Completed
Not Applicable
Pilot Study of Acute Stroke Using the Brainpulse™Stroke, AcuteNCT03235271Jan Medical, Inc.252
Active, not recruiting
Not Applicable
An Observational Study to Learn More About How Well a Treatment Works When Given After Treatment With Atezolizumab and Bevacizumab or Another Similar Combination of Drugs in Adults With Liver Cancer That Cannot be Treated With SurgeryUnresectable Hepatocellular CarcinomaNCT06117891Bayer300
Completed
Not Applicable
Geriatric Assessmen of Elderly "Unsuited" Patients Receiving Trabectedin in First Line Treatment For Advanced Soft Tissue Sarcomas (STS)Advanced Soft-tissue SarcomaMetastatic Soft-tissue SarcomaNCT03022448GWT-TUD GmbH72
Completed
Not Applicable
A Study to Assess the Efficacy of Raltegravir (Isentress®), Administered in Combination With Other Antiretroviral Drugs as Treatment for Adults and Older Adults Infected With the Human Immunodeficiency Virus 1 (HIV-1)(MK-0518-145) (Wirksamkeit Von Isentress® Unter Praxisbedingungen)HIV-1 InfectionNCT01213316Merck Sharp & Dohme LLC451