Post-registration Trial of the Non-immunogenic Staphylokinase in Acute Ischemic Stroke (FORPI Reg… (NCT06707987) | Clinical Trial Compass
CompletedNot Applicable
Post-registration Trial of the Non-immunogenic Staphylokinase in Acute Ischemic Stroke (FORPI Registry)
Russia23,250 participantsStarted 2021-03-01
Plain-language summary
The aim of FORPI Registry is to study the safety and efficacy of the non-immunogenic staphylokinase in patients with acute ischemic stroke in routine clinical practice.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* Str…
What they're measuring
1
Modified Rankin Scale (mRS) score of 0-2 on day 90 after drug administration