Acute StrokeNCT05297851
Cytoflavin in Combination With Reperfusion in Stroke Patients
An observational study of Acute Stroke, run by POLYSAN Scientific & Technological Pharmaceutical Company at 7 sites in Russia.
Trial summary
Evaluation of the efficacy and safety of Cytoflavin®, solution for intravenous administration, (OOO NTFF POLYSAN, Russia) for 10 days, patients with cerebral infarction who receive reperfusion therapy, with the start of treatment within the first 24 hours from the stroke onset, compared to treament with any other… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Stroke
- What is being tested?
- Cytoflavin (succinic acid + inosine + nicotinamide + riboflavin)
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 7 sitesRussia
- Study dates
- 10 Apr 2022to 1 Mar 2023
- 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 to 85 years
- All sexes
- Adult, Older adult
Study population: Men and women 18-85 y.o. with acute stroke who receive reperfusion (intravenous thrombolysis and/or mechanical thrombectomy) and continue treatment in the acute stroke unit
Who may be able to join
- Signed Informed Consent;
- Men and women 18-85 y.o.;
- A diagnosis of "cerebral infarction" has been established and treatment with Cytoflavin® has already been prescribed, or other therapy has been prescribed that does not include Cytoflavin®;
- NIHSS score of at least 5 and less than 24;
- reperfusion therapy performed on admission;
- The size of the ischemic focus according to ASPECTS score >=6;
Show all 9Show fewer
- Time from stroke onset to admission not exceeeding 6 hours;
- Start of therapy with Cytoflavin® within 24 hours from the onset of stroke (main group);
- Patients who are able to follow the procedures of the Observational Study Program and strictly follow the doctor's instructions regarding drug therapy.
Who cannot join
- Individual intolerance or known hypersensitivity to succinic acid, inosine, nicotinamide, riboflavin, or auxiliary components of the drug Cytoflavin®;
- Hemorrhagic stroke;
- Contraindications for CT scanning;
- Initial severe disability requiring assistance in everyday life before stroke;
- previous stroke with a residual neurological deficit;
- Severe comorbidity with a life expectancy of less than 6 months;
- Clinical or laboratory signs of an infectious disease on admission (with the exception of strokes that occurred in COVID-19 convalescents after the first 10 days of illness, and patients with asymptomatic SARS-CoV-2 infection detected during routine examination);
- Pregnancy or lactation
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Russia7 sites
Northern State Medical University of the Ministry of Health of the Russian Federation
Arkhangelsk
Belgorod Regional Clinical Hospital of St. Joasaph
Belgorod
Interregional Clinical and Diagnostic Center
Kazan'
City Hospital of the Holy Martyr Elizabeth
Saint Petersburg, 197706
City General Hospital №2
Saint Petersburg
City Mariinsky Hospital
Saint Petersburg
SPb GBUZ "City Hospital №26"
Saint Petersburg
About this study
Official title: Non-interventional Prospective Observational Study of Efficacy and Safety of Cytoflavin in Combination With Reperfusion Compared to Treatment With Other Neuroprotective Drugs Used in Routine Clinical Practice in Patients With Cerebral Infarction
Evaluation of the efficacy and safety of Cytoflavin®, solution for intravenous administration, (OOO NTFF POLYSAN, Russia) for 10 days, patients with cerebral infarction who receive reperfusion therapy, with the start of treatment within the first 24 hours from the stroke onset, compared to treament with any other neuroprotective drug which may be used in routine clinical practice.
- Conditions
- Acute Stroke
- Being tested
- Cytoflavin (succinic acid + inosine + nicotinamide + riboflavin), Control
- Keywords
- acute stroke, cerebral infarction, neuroprotection
- Medical subject headings
- Stroke, Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytoflavin (succinic acid + inosine + nicotinamide + riboflavin)Drug
10 ml diluted to 100-200 ml of 5-10% dextroseor 0.9% sodium chloride solution. The rate of administration is 3-4 ml / min. The drug is administered in a volume of 10 ml per injection with an interval of 8-12 hours for 10 days. In severe cases of the disease, a single dose is increased to 20 ml.
ControlDrug
Standard treatment accordind to the routine clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Cytoflavin | Patients who underwent reperfusion for acute stroke (intravenous thrombolysis and/or mechanical thrombectomy) and receive intravenous Cytoflavin® at a discretion of the physician, starting this treatment within the first 24 hours from the onset of stroke Receives: Drug: Cytoflavin (succinic acid + inosine + nicotinamide + riboflavin) | |
| Control | Patients who underwent reperfusion for acute stroke (intravenous thrombolysis and/or mechanical thrombectomy) and do not receive Cytoflavin as part of their routine clinical practice, but may receive any other neuroprotective medications. Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with good functional outcome
Proportion of patients who achieve score 0-2 by modified Rankin scale
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start10 Apr 2022
- Primary completion28 Feb 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- POLYSAN Scientific & Technological Pharmaceutical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dina R Khasanova, prof., Principal investigator, Interregional Clinical and Diagnostic Center, Kazan, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05297851
- Sponsor's protocol ID
- CTF-STRobs-22
- Status last verified
- Mar 2023
- First submitted
- 17 Mar 2022
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Prospective Observational Study of Efficacy and Safety of Cytoflavin in Combination With Reperfusion Compared to Treatment With Other Neuroprotective Drugs Used in Routine Clinical Practice in Patients With Cerebral Infarction
- ClinicalTrials.gov ID
- NCT05297851
- Acronym / sponsor ID
- CTF-STRobs-22
- Conditions
- Acute Stroke
- Keywords
- acute stroke, cerebral infarction, neuroprotection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- POLYSAN Scientific & Technological Pharmaceutical CompanyIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 28 Mar 2022 (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.
Evaluation of the efficacy and safety of Cytoflavin®, solution for intravenous administration, (OOO NTFF POLYSAN, Russia) for 10 days, patients with cerebral infarction who receive reperfusion therapy, with the start of treatment within the first 24 hours from the stroke onset, compared to treament with any other neuroprotective drug which may be used in routine clinical practice.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cytoflavin | – | Drug: Cytoflavin (succinic acid + inosine + nicotinamide + riboflavin)Patients who underwent reperfusion for acute stroke (intravenous thrombolysis and/or mechanical thrombectomy) and receive intravenous Cytoflavin® at a discretion of the physician, starting this treatment within the first 24 hours from the onset of stroke |
| Control | – | Drug: ControlPatients who underwent reperfusion for acute stroke (intravenous thrombolysis and/or mechanical thrombectomy) and do not receive Cytoflavin as part of their routine clinical practice, but may receive any other neuroprotective medications. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Men and women 18-85 y.o. with acute stroke who receive reperfusion (intravenous thrombolysis and/or mechanical thrombectomy) and continue treatment in the acute stroke unit
Key inclusion criteria (9 listed)
- Signed Informed Consent;
- Men and women 18-85 y.o.;
- A diagnosis of "cerebral infarction" has been established and treatment with Cytoflavin® has already been prescribed, or other therapy has been prescribed that does not include Cytoflavin®;
- NIHSS score of at least 5 and less than 24;
- reperfusion therapy performed on admission;
Key exclusion criteria (8 listed)
- Individual intolerance or known hypersensitivity to succinic acid, inosine, nicotinamide, riboflavin, or auxiliary components of the drug Cytoflavin®;
- Hemorrhagic stroke;
- Contraindications for CT scanning;
- Initial severe disability requiring assistance in everyday life before stroke;
- previous stroke with a residual neurological deficit;
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 |
|---|---|---|
| Cytoflavin (succinic acid + inosine + nicotinamide + riboflavin)10 ml diluted to 100-200 ml of 5-10% dextroseor 0.9% sodium chloride solution. The rate of administration is 3-4 ml / min. The drug is administered in a volume of 10 ml per injection with an interval of 8-12 hours for 10 days. In severe cases of the disease, a single dose is increased to 20 ml. | Drug | Cytoflavin |
| ControlStandard treatment accordind to the routine clinical practice | Drug | Control |
Primary outcome
Proportion of patients with good functional outcome
Time frame: 90 days
Proportion of patients who achieve score 0-2 by modified Rankin scale
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 20 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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.
Dina R Khasanova, prof. principal investigator
Interregional Clinical and Diagnostic Center, Kazan, Russia
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Stroke, run by POLYSAN Scientific & Technological Pharmaceutical Company at 7 sites 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 9 inclusion and 8 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 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Proportion of patients with good functional outcome (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2023.