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

Completed

• Conditions: Acute Ischemic Stroke
• Interventions: Drug: Non-immunogenic staphylokinase

• Registration Number: NCT06707987
• Lead Sponsor: Supergene, LLC

Brief 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.

Detailed Description

Acute ischemic stroke is caused by the formation of blood clot in the major vessel which gives blood supply to a certain part of the brain. New approaches to the treatment of acute ischemic stroke include the use of modern highly effective methods of reperfusion of brain tissue in the first hours of the disease, aimed at restoring blood flow in the affected vessel, which helps prevent the development of irreversible damage to brain tissue or reduce its volume, i.e. minimize the severity of residual neurological deficit.

In December 2019, a multicenter, open-label, randomized non-inferiority trial of the efficacy and safety of the non-immunogenic staphylokinase (Fortelyzin®) compared with alteplase (Actilyse®) in patients with acute ischemic stroke (FRIDA) was completed (NCT03151993).

The primary efficacy outcome in both the non-immunogenic staphylokinase and alteplase groups, as well as in their subgroups depending on age, body weight, onset to treatment time, baseline NIHSS, localization and subtype of acute ischemic stroke showed that the non-immunogenic staphylokinase administered as a single bolus in a dose of 10 mg regardless of body weight is non-inferior to alteplase, administered as a bolus infusion at a dose of 0.9 mg/kg body weight, at a maximum dose of 90 mg in the treatment of patients with acute ischemic stroke within 4.5 hours from the symptoms onset. The non-immunogenic staphylokinase has demonstrated high safety profile. The indication "acute ischemic stroke" is included in the Instructions for medical use of the non-immunogenic staphylokinase. In routine clinical practice, the non-immunogenic staphylokinase is used for acute ischemic stroke treatment since 2021.

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.

Study Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2024-11-19
• Study First Submitted QC: 2024-11-23
• Study First Posted: 2024-11-27
• Primary Completion: 2024-12-31
• Status Verified: 2025-02
• Study Completion: 2025-02-01
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23250

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-immunogenic staphylokinase	Non-immunogenic staphylokinase	Drug: non-immunogenic staphylokinase

Primary Outcome Measures

Name	Time	Method
Modified Rankin Scale (mRS) score of 0-2 on day 90 after drug administration	day 90 after drug administration	The number of patients with Modified Rankin Scale (mRS) scores 0-2 on day 90 after drug administration, where 0 - No symptoms, 1 - No significant disability, 2 - Slight disability.

Secondary Outcome Measures

Name	Time	Method
mRS score on day 90 after drug administration	day 90 after drug administration	The median of mRS score on day 90 after drug administration, where: 0 - No symptoms, 1 - No significant disability, 2 - Slight disability, 3 - Moderate disability, 4 - Moderately severe disability, 5 - Severe disability, 6 - Dead.
The National Institutes of Health Stroke Scale (NIHSS) at 24 hours after drug administration	24 hours after drug administration	The median of The National Institutes of Health Stroke Scale (NIHSS) at 24 h after drug administration, where: 0 - No stroke symptoms, 1-4 - Minor stroke, 5-15 - Moderate stroke, 16-20 - Moderate to severe stroke, 21-42 - Severe stroke.
NIHSS on day 7 after drug administration	day 7 after drug administration	The median of NIHSS on discharge

Trial Locations

Locations (1)

Federal Brain and Neurotechnology Center; 🇷🇺 Moscow, Russian Federation