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.
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 Type
OBSERVATIONAL
Enrollment
23,250
Drug: non-immunogenic staphylokinase 10 mg as a single intravenous bolus Other Names: Fortelyzin®
Federal Brain and Neurotechnology Center
Moscow, Russia
Modified Rankin Scale (mRS) score of 0-2 on 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.
Time frame: day 90 after drug administration
mRS score on 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.
Time frame: day 90 after drug administration
The National Institutes of Health Stroke Scale (NIHSS) at 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.
Time frame: 24 hours after drug administration
NIHSS on day 7 after drug administration
The median of NIHSS on discharge
Time frame: day 7 after drug administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.