An observational study in Acute Ischemic Stroke, sponsored by Supergene, LLC. Completed at 1 site in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-05.
Sponsored by Supergene, LLC · Observational
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.
2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.
This study's enrollment of 23,250 is above the median of 300 across 777 observational studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Supergene, LLC is the lead sponsor of 9 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Men and women aged 18 years and older with verified acute ischemic stroke, less than 4.5 h symptoms onset to treatment, who received a single intravenous bolus of the non-immunogenic staphylokinase (10 mg).
Exclusion Criteria:
Drug: non-immunogenic staphylokinase
Drug: Non-immunogenic staphylokinase
Drug: non-immunogenic staphylokinase 10 mg as a single intravenous bolus Other Names: Fortelyzin®
Also known as: Fortelyzin®
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
All-cause mortality
The number of death from any causes during 90 days after drug administration
Time frame: day 90 after drug administration
Intracranial haemorrhage
The number of intracranial haemorrhage during 90 days after drug administration
Time frame: day 90 after drug administration
Symptomatic intracerebral haemorrhage
The number of symptomatic intracranial haemorrhage (sICH) defined as an NIHSS decline of ≥4 points compared with baseline NIHSS or the lowest NIHSS value or death between baseline and 7 days, associated with any haemorrhage judged by core lab evaluation to be responsible for the decline. Blood may be anywhere in the intracranial space including in the intraventricular, intraparenchymal and/or subarachnoid space (modified ECASS III definition) during 90 days after drug administration
Time frame: day 90 after drug administration
Major bleedings
The number of major bleedings (according to BARC classification type 3 and 5) during 90 days after drug administration
Time frame: day 90 after drug administration
Thrombectomy
The number of thrombectomy during 90 days after drug administration
Time frame: day 90 after drug administration
Allergic reactions
The number of allergic reactions during 90 days after drug administration
Time frame: day 90 after drug administration
Pulmonary embolism
The number of pulmonary embolism during 90 days after drug administration
Time frame: day 90 after drug administration
Plan to share: No
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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