Massive stroke drug study shows Real-World results
NCT ID NCT06707987
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a clot-dissolving drug called non-immunogenic staphylokinase in over 23,000 adults who had an acute ischemic stroke within the last 4.5 hours. The goal was to see how safe and effective the drug is in everyday hospital practice. Researchers measured how many patients had little or no disability 90 days after treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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23,250 people
The number who actually took part.
- Started
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Mar 2021
- Finished
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Feb 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Men and women aged 18 years and older with verified acute ischemic stroke, less than 4.5 h symptoms onset to treatment, who received a single intravenous bolus of the non-immunogenic staphylokinase (10 mg).
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Men and women aged 18 years and older. * Verified diagnosis of acute ischemic stroke. * The time from the symptoms onset is no more than 4.5 hours. * Thrombolysis with the non-immunogenic staphylokinase, 10 mg as a single intravenous bolus. Exclusion Criteria: * The time from the symptoms onset is more than 4.5 hours or the time of the symptoms onset is unknown. * Increased sensitivity to the non-immunogenic staphylokinase. * Systolic blood pressure above 185 mm Hg or diastolic blood pressure above 110 mm Hg or the need in the drug administration to reduce blood pressure to these levels. * Neuroimaging (CT, MRI) signs of intracranial hemorrhage, brain tumors, arteriovenous malformation, brain abscess, aneurysm of cerebral vessels. * Surgery on the brain or spinal cord. * Suspicion of subarachnoid hemorrhage. * Signs of severe stroke: clinical signs (stroke scale NIH \> 25), neuroimaging (according to CT of the brain and / or MRI of the brain in the DWI, the ischemia focuses on the territory of more than 1/3 of the CMA pool). * Simultaneous reception of oral anticoagulants, for example, warfarin with INR\> 1.3. * The use of direct anticoagulants (heparin, heparinoids) in the preceding stroke of 48 h with APTT values above the norm. * Prior stroke or severe head injury within 3 months. * Significant regression of neurological symptoms during the observation of the patient before thrombolysis. * Hemorrhagic stroke or stroke, unspecified in history. * Strokes of any genesis in the history of a patient with diabetes mellitus. * Gastrointestinal bleeding or bleeding from the genitourinary system in the last 3 weeks. Confirmed exacerbations of gastric ulcer and duodenal ulcer during the last 3 months. * Extensive bleeding now or within the previous 6 months. * Severe liver disease, including liver failure, cirrhosis, portal hypertension (with varicose veins of the esophagus), active hepatitis. * Acute pancreatitis. * Bacterial endocarditis, pericarditis. * Aneurysms of arteries, malformations of arteries and veins. Suspicion of exfoliating aortic aneurysm. * Neoplasms with an increased risk of bleeding. * Large operations or severe injuries within the last 14 days, minor surgery or invasive manipulation in the last 10 days. * Puncture of uncompensated arteries and veins during the last 7 days. * Prolonged or traumatic cardiopulmonary resuscitation (more than 2 min). * Pregnancy, obstetrics, 10 days after birth. * The number of platelets is less than 100,000 / μL. * Blood glucose less than 2.7 mmol / L or more than 22.0 mmol / L. * Hemorrhagic diathesis, including renal and hepatic insufficiency. * Data on bleeding or acute trauma (fracture) at the time of examination. * Seizures in the onset of the disease, if there is no certainty that the seizure is a clinical manifestation of acute ischemic stroke with a postictal residual deficiency.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Federal Brain and Neurotechnology Center
Moscow, 117513, Russia
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Other studies related to the condition(s) this trial covers.
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