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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with good functional outcome | Proportion of patients who achieve score 0-2 by modified Rankin scale | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Dina R Khasanova, prof. | Interregional Clinical and Diagnostic Center, Kazan, Russia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northern State Medical University of the Ministry of Health of the Russian Federation | Arkhangelsk | Russia | ||||
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D002544 | Cerebral Infarction |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C507879 | cytoflavin |
| D019802 | Succinic Acid |
| D007288 | Inosine |
| D009536 | Niacinamide |
| D012256 | Riboflavin |
| ID | Term |
|---|---|
| D013386 | Succinates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| Control | Drug | Standard treatment accordind to the routine clinical practice |
|
| Belgorod Regional Clinical Hospital of St. Joasaph |
| Belgorod |
| Russia |
| Interregional Clinical and Diagnostic Center | Kazan' | Russia |
| City Hospital of the Holy Martyr Elizabeth | Saint Petersburg | 197706 | Russia |
| City General Hospital №2 | Saint Petersburg | Russia |
| City Mariinsky Hospital | Saint Petersburg | Russia |
| SPb GBUZ "City Hospital №26" | Saint Petersburg | Russia |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D009930 |
| Organic Chemicals |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D005415 | Flavins |
| D011621 | Pteridines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |