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Massive stroke drug study shows Real-World results

NCT ID NCT06707987

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

23,250 people

The number who actually took part.

Started

Mar 2021

Finished

Feb 2025

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Federal Brain and Neurotechnology Center

    Moscow, 117513, Russia

More trials for these conditions

Other studies related to the condition(s) this trial covers.