Post-registration Trial of the Non-immunogenic Staphylokinase in Acute Ischemic Stroke (FORPI Registry)

Prior treatment

• 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.
• Surgery on the brain or spinal cord.
• Prior stroke or severe head injury within 3 months.
• Extensive bleeding now or within the previous 6 months.
• Large operations or severe injuries within the last 14 days, minor surgery or invasive manipulation in the last 10 days.

Other illness

• Neuroimaging (CT, MRI) signs of intracranial hemorrhage, brain tumors, arteriovenous malformation, brain abscess, aneurysm of cerebral vessels.
• 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).
• 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.
• Severe liver disease, including liver failure, cirrhosis, portal hypertension (with varicose veins of the esophagus), active hepatitis.
• Neoplasms with an increased risk of bleeding.
• 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.

Lab values

• 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.
• 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.

Other

• 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.
• Significant regression of neurological symptoms during the observation of the patient before thrombolysis.
• Acute pancreatitis.
• Bacterial endocarditis, pericarditis.
• Aneurysms of arteries, malformations of arteries and veins. Suspicion of exfoliating aortic aneurysm.
• 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.

• 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.