Actively Recruiting

Phase 3
Age: 35Years - 80Years
All Genders
NCT07167550

The Study of Efficacy and Safety of Dimephosphon® in Acute Ischemic Stroke

Led by Tatchempharmpreparaty, JSC · Updated on 2025-09-11

184

Participants Needed

6

Research Sites

33 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

A multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Dimephosphon® in acute ischemic stroke

CONDITIONS

Official Title

The Study of Efficacy and Safety of Dimephosphon® in Acute Ischemic Stroke

Who Can Participate

Age: 35Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Written informed consent obtained from patient or legal representative prior to participation
  • Age between 35 and 80 years
  • Neurological signs consistent with acute ischemic stroke with onset-to-treatment time between 24 and 72 hours
  • Current hemispheric ischemic stroke verified by CT or MRI
  • NIH Stroke Scale score between 5 and 15 at screening
  • Ability to comply with all study procedures and restrictions
  • Willingness and ability to use highly effective contraception as required by the study protocol
Not Eligible

You will not qualify if you...

  • Hemorrhagic stroke, hemorrhagic transformation of ischemic focus, or traumatic brain injuries
  • Vertebrobasilar stroke or acute insufficiency in vertebrobasilar arteries
  • Candidates for or prior recipients of reperfusion therapy before study participation
  • Anatomical abnormalities of cerebral vessels such as arteriovenous malformations, cavernous malformations, aneurysms, or artery atresia
  • Progression of stroke symptoms with NIHSS score increase of 4 points before randomization
  • Carotid artery surgery less than 1 year before screening
  • Stroke history less than 1 year before screening
  • Myocardial infarction less than 6 months before screening
  • Chronic renal failure stage 2-3 with creatinine clearance below 40 ml/min
  • Pregnancy or breastfeeding
  • Participation in another clinical trial within 28 days before enrollment
  • Use of prohibited medications

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

State Budgetary Healthcare Institution of the Leningrad Region "Vsevolozhsk Interdistrict Clinical Hospital

Vsevolozhsk, Leningradskaya Oblast', Russia, 188643

Actively Recruiting

2

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 region

Krasnodar, Russia, 350086

Not Yet Recruiting

3

Federal State Autonomous Educational Institution of Higher Education "Peoples' Friendship University of Russia named after Patrice Lumumba"

Moscow, Russia, 117198

Actively Recruiting

4

The FSBI "Federal Center of Brain Research and Neurotechnologies" of the Federal Medical and Biological Agency

Moscow, Russia, 117513

Actively Recruiting

5

Saint Petersburg State Budgetary Healthcare Institution "City Hospital No. 40 of the Kurortny District"

Saint Petersburg, Russia, 197706

Actively Recruiting

6

State Budgetary Healthcare Institution "City Hospital No. 4 of Sochi" of the Ministry of Healthcare of the Krasnodar Region

Sochi, Russia, 354057

Actively Recruiting

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Research Team

A

Alfiya Fakhrieva

CONTACT

A

Alyona Tirskaya

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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