Single Bolus Recombinant Nonimmunogenic Staphylokinase (Fortelyzin) and Bolus Infusion Alteplase in Patients With AIS

• Status: Completed
• Trial end date: 2019-06-20
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to determine if single-bolus recombinant nonimmunogenic staphylokinase is effective and save thrombolytic agent in patients with ischemic stroke in comparison to alteplase.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Supergene, LLC
• Treatments: Tissue Plasminogen Activator

Criteria

Inclusion Criteria:

• Men and women between the ages of 18 and 80 (Version 1.0)

• Men and women aged 18 years and older, after 80 years with caution (Version 2.0)

• Verified diagnosis of ischemic stroke (from 5 to 25 points on the NIHSS scale). (Version 1.0)

• Verified diagnosis of ischemic stroke (Version 2.0)

• The time from the onset of the disease is no more than 4.5 hours.

• Informed consent received

Exclusion Criteria:

• The time of the onset of the first symptoms is more than 4.5 hours from the onset of the disease or the time of the onset of the first symptoms of a stroke is not known (for example, the development of a stroke during sleep - the so-called "night stroke").

• Increased sensitivity to alteplase, gentamicin (residual traces from the production process).

• Systolic blood pressure above 185 mm Hg. Art. Or diastolic blood pressure above 110 mm Hg. Art. Or the need for / in the administration of drugs to reduce blood pressure to these boundaries.

• 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.(Version 1.0)

• Light neurological symptoms (NIH <4 points). (Version 1.0)

• Significant regression of neurological symptoms during the observation of the patient before thrombolisis (Version 2.0)

• 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 ischemic stroke with a postictal residual deficiency.