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

NCT06707987 | Completed

• 1 other identifier: FORPI
• Study Type: observational
• Target: 23,250
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke

Keywords

Acute ischemic stroke; Fibrinolysis; Thrombolysis; Non-immunogenic staphylokinase

Outcome Measures

Primary Outcomes (1)

• 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.

  day 90 after drug administration

Secondary Outcomes (3)

• mRS score on day 90 after drug administration

  day 90 after drug administration

• The National Institutes of Health Stroke Scale (NIHSS) at 24 hours after drug administration

  24 hours after drug administration

• NIHSS on day 7 after drug administration

  day 7 after drug administration

Other Outcomes (7)

• All-cause mortality

  day 90 after drug administration

• Intracranial haemorrhage

  day 90 after drug administration

• Symptomatic intracerebral haemorrhage

  day 90 after drug administration

Study Arms (1)

Non-immunogenic staphylokinase

Drug: non-immunogenic staphylokinase

Drug: Non-immunogenic staphylokinase

Interventions

Non-immunogenic staphylokinase DRUG

Drug: non-immunogenic staphylokinase 10 mg as a single intravenous bolus Other Names: Fortelyzin®

Also known as: Fortelyzin®

Non-immunogenic staphylokinase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Supergene, LLC: lead
• Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health: collaborator

Study Sites (1)

Federal Brain and Neurotechnology Center

Moscow, 117513, Russia

Location

Related Publications (7)

• Gusev EI, Martynov MY, Nikonov AA, Shamalov NA, Semenov MP, Gerasimets EA, Yarovaya EB, Semenov AM, Archakov AI, Markin SS; FRIDA Study Group. Non-immunogenic recombinant staphylokinase versus alteplase for patients with acute ischaemic stroke 4.5 h after symptom onset in Russia (FRIDA): a randomised, open label, multicentre, parallel-group, non-inferiority trial. Lancet Neurol. 2021 Sep;20(9):721-728. doi: 10.1016/S1474-4422(21)00210-6.

  PMID: 34418399 BACKGROUND

• Alasheev AM, Lantsova EV, Tretyakov DA. [Efficacy and safety of non-immunogenic staphylokinase in the ischemic stroke in real-world clinical practice in the Sverdlovsk region]. Zh Nevrol Psikhiatr Im S S Korsakova. 2023;123(7):74-79. doi: 10.17116/jnevro202312307174. Russian.

  PMID: 37490668 BACKGROUND

• Ramazanov GR, Kokov LS, Shamalov NA, Kovaleva EA, Klychnikova EV, Akhmatkhanova LK, Cheboksarov DV, Khamidova LT, Muslimov RS, Rybalko NV, Petrikov SS. [First case of thrombolysis with non-immunogenic staphylokinase in a patient with ischemic stroke receiving dabigatran etexilate followed by thrombectomy]. Zh Nevrol Psikhiatr Im S S Korsakova. 2022;122(6):145-151. doi: 10.17116/jnevro2022122061145. Russian.

  PMID: 35758961 BACKGROUND

• Kulesh AA, Syromyatnikova LI, Krapivin S, Astanin PV. [Comparison of the effectiveness of non-immunogenic staphylokinase and alteplase for intravenous thrombolysis in ischemic stroke: analysis of hospital registry data]. Zh Nevrol Psikhiatr Im S S Korsakova. 2024;124(7):139-144. doi: 10.17116/jnevro2024124071139. Russian.

  PMID: 39113454 BACKGROUND

• Gusev EI, Martynov MY, Shamalov NA, Yarovaya EB, Semenov MP, Semenov AM, Orlovsky AA, Kutsenko VA, Nikonov AA, Aksentiev SB, Yunevich DS, Alasheev AM, Androfagina OV, Bobkov VV, Choroshavina KV, Gorbachev VI, Korobeynikov IV, Greshnova IV, Dobrovolskiy AV, Elemanov UA, Zhukovskaya NV, Zakharov SA, Chirkov AN, Korsunskaya LL, Nesterova VN, Nikonova AA, Nizov AA, Girivenko AI, Ponomarev EA, Popov DV, Pribylov SA, Semikhin AS, Timchenko LV, Jadan ON, Fedyanin SA, Chefranova ZY, Lykov YA, Chuprina SE, Vorobev AA, Archakov AI, Markin SS. [Nonimmunogenic staphylokinase in the treatment of acute ischemic stroke (FRIDA trial results)]. Zh Nevrol Psikhiatr Im S S Korsakova. 2022;122(7):56-65. doi: 10.17116/jnevro202212207156. Russian.

  PMID: 35904293 BACKGROUND

• Shamalov NA, Martynov MY, Yarovaya EB, Chefranova ZY, Kutsenko VA, Semenov AM, Ivanov SV, Semenov MP, Markin SS, Gusev EI; FORPI Study Group. Thrombolysis With the Non-Immunogenic Staphylokinase for Acute Ischemic Stroke in the FORPI Registry: An Observational Study. Stroke. 2026 Feb;57(2):394-403. doi: 10.1161/STROKEAHA.125.051115. Epub 2025 Nov 26.

  PMID: 41293810 RESULT

• Shamalov NA, Chefranova ZY, Yarovaya EB, Kutsenko VA, Marskaya NA, Semenov AM, Semenov MP, Ivanov SV, Romashova YA, Markin SS. Prognostic outcome of intravenous thrombolysis with non-immunogenic staphylokinase in patients aged >/= 60 years with acute ischemic stroke by THRIVE scale. J Thromb Thrombolysis. 2025 Nov 16. doi: 10.1007/s11239-025-03212-0. Online ahead of print.

  PMID: 41243072 RESULT

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Nikolay A. Shamalov, MD, PhD Prof

  Federal Brain and Neurotechnology Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 27, 2024
• Study Start: March 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: February 1, 2025
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)