Acute Ischemic StrokeNCT06707987
Post-registration Trial of the Non-immunogenic Staphylokinase in Acute Ischemic Stroke (FORPI Registry)
An observational study of Acute Ischemic Stroke, run by Supergene, LLC at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Non-immunogenic staphylokinase
- Type of treatment
- Injection or infusion
- How many people
- 23,250 participants
- Where
- 1 siteRussia
- Study dates
- 1 Mar 2021to 1 Feb 2025
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 29Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open, Prospective, Non-interventional, Multicentre, Controlled Study of Safety and Efficacy of the Thrombolysis With the Non-immunogenic Staphylokinase in Patients With Acute Ischemic Stroke (FORPI Registry)
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.
Read the 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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Non-immunogenic staphylokinase
- Keywords
- Acute ischemic stroke, Fibrinolysis, Thrombolysis, Non-immunogenic staphylokinase
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-immunogenic staphylokinaseDrug
Also called Fortelyzin®
Drug: non-immunogenic staphylokinase 10 mg as a single intravenous bolus Other Names: Fortelyzin®
| Study group | Role | What they receive |
|---|---|---|
| Non-immunogenic staphylokinase | Drug: non-immunogenic staphylokinase Receives: Drug: Non-immunogenic staphylokinase |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 90 after drug administration
Secondary outcomes (3)
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.
Measured: 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.
Measured: 24 hours after drug administration
NIHSS on day 7 after drug administration
The median of NIHSS on discharge
Measured: day 7 after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start1 Mar 2021
- Primary completion31 Dec 2024
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23,250 participants (actual)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Supergene, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health
- Responsible party
- Sponsor
- Investigators
- Nikolay A. Shamalov, MD, PhD Prof, Principal investigator, Federal Brain and Neurotechnology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707987
- Sponsor's protocol ID
- FORPI
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2024
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34418399Alasheev 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.
PubMed 37490668Ramazanov 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.
PubMed 35758961Kulesh 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.
PubMed 39113454Gusev 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.
PubMed 35904293Shamalov 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.
PubMed 41293810Shamalov 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. 2026 Apr;59(4):993-1002. doi: 10.1007/s11239-025-03212-0. Epub 2025 Nov 16.
PubMed 41243072
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Prospective, Non-interventional, Multicentre, Controlled Study of Safety and Efficacy of the Thrombolysis With the Non-immunogenic Staphylokinase in Patients With Acute Ischemic Stroke (FORPI Registry)
- ClinicalTrials.gov ID
- NCT06707987
- Acronym / sponsor ID
- FORPI
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute ischemic stroke, Fibrinolysis, Thrombolysis, Non-immunogenic staphylokinase
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23,250 participants (actual)
- Lead sponsor
- Supergene, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Federal Center of Cerebrovascular Pathology and Stroke, Russian Federation Ministry of Health
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 27 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-immunogenic staphylokinase | – | Drug: Non-immunogenic staphylokinaseDrug: non-immunogenic staphylokinase |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (29 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-immunogenic staphylokinaseAlso: Fortelyzin®Drug: non-immunogenic staphylokinase 10 mg as a single intravenous bolus Other Names: Fortelyzin® | Drug | Non-immunogenic staphylokinase |
Primary outcome
Modified Rankin Scale (mRS) score of 0-2 on day 90 after drug administration
Time frame: 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.
3 secondary outcomes
mRS score on day 90 after drug administration
Time frame: day 90 after drug administration
The National Institutes of Health Stroke Scale (NIHSS) at 24 hours after drug administration
Time frame: 24 hours after drug administration
NIHSS on day 7 after drug administration
Time frame: day 7 after drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Background: PubMed 34418399Gusev 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.
- Background: PubMed 37490668Alasheev 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.
- Background: PubMed 35758961Ramazanov 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.
- Background: PubMed 39113454Kulesh 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.
- Background: PubMed 35904293Gusev 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.
- Results publication: PubMed 41293810Shamalov 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.
- Results publication: PubMed 41243072Shamalov 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. 2026 Apr;59(4):993-1002. doi: 10.1007/s11239-025-03212-0. Epub 2025 Nov 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nikolay A. Shamalov, MD, PhD Prof principal investigator
Federal Brain and Neurotechnology Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke, run by Supergene, LLC at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale (mRS) score of 0-2 on day 90 after drug administration (time frame: day 90 after drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06707987, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.