The Study of Efficacy and Safety of Dimephosphon® in Acute Ischemic Stroke
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age35-80
SponsorTatchempharmpreparaty, JSC
About this trial
A multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Dimephosphon® in acute ischemic stroke
Eligibility criteria
Qualifiers
Written informed consent was obtained from the patient or their legally authorized representative prior to study participation.
Age 35-80.
Patients must exhibit neurological manifestations consistent with acute ischemic stroke, with a documented onset-to-intervention interval ranging from 24 to 72 hours at the time of scheduled initial administration of the investigational drug.
Verified by CT/MRI current hemispheric ischemic stroke.
Disqualifiers
Hemorrhagic stroke or hemorrhagic transformation of ischemic focus, traumatic brain injuries
Vertebrobasilar stroke and/or development of acute insufficiency syndromes in the arteries of the vertebrobasilar system
A patient with ischemic stroke who is a candidate for reperfusion therapy or who has undergone reperfusion therapy before participation in this study.
The presence of anatomical abnormalities of the cerebral vessels (arteriovenous malformations, cavernous malformations, aneurysms, atresia of at least one of the extracranial arteries) according to the anamnesis or CT/MRI data.
Trial design
Treatments tested in this trial
- Dimephosphon®
- Placebo
Treatment groups
184 Participants
are divided into 2 treatment groupsLocations
6State Budgetary Healthcare Institution of the Leningrad Region "Vsevolozhsk Interdistrict Clinical Hospital188643, VsevolozhskLeningradskaya Oblast', Russia
State Budgetary Healthcare Institution "Research Institute - Regional Clinical Hospital No. 1 named after Professor S.V. Ochapovsky" of the Ministry of Health of the Krasnodar region350086, Krasnodar Russia
Federal State Autonomous Educational Institution of Higher Education "Peoples' Friendship University of Russia named after Patrice Lumumba"117198, Moscow Russia
The FSBI "Federal Center of Brain Research and Neurotechnologies" of the Federal Medical and Biological Agency117513, Moscow Russia
Sponsors and collaborators
Tatchempharmpreparaty, JSC
Lead sponsor
Source ClinicalTrials.gov