NCT07167550 The Study of Efficacy and Safety of Dimephosphon® in Acute Ischemic Stroke
| NCT ID | NCT07167550 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Tatchempharmpreparaty, JSC |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 184 participants |
| Start Date | 2025-09-06 |
| Primary Completion | 2026-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 184 participants in total. It began in 2025-09-06 with a primary completion date of 2026-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Dimephosphon® in acute ischemic stroke
Eligibility Criteria
Inclusion Criteria: 1. Written informed consent was obtained from the patient or their legally authorized representative prior to study participation. 2. Age 35-80. 3. 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. 4. Verified by CT/MRI current hemispheric ischemic stroke. 5. NIHSS score ≥5 and ≤15 at screening. 6. Ability to comply with all protocol-specified procedures, prohibitions, and restrictions. 7. Willingness and ability to adhere to highly effective contraceptive methods as outlined in the study protocol. Exclusion Criteria: 1. Hemorrhagic stroke or hemorrhagic transformation of ischemic focus, traumatic brain injuries 2. Vertebrobasilar stroke and/or development of acute insufficiency syndromes in the arteries of the vertebrobasilar system 3. A patient with ischemic stroke who is a candidate for reperfusion therapy or who has undergone reperfusion therapy before participation in this study. 4. 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. 5. Progression of neurological symptoms of stroke, defined as an increase in the NIHSS score by 4 points at the second assessment (immediately before randomization) from the value obtained at the first assessment (immediately after signing the informed consent form). 6. Surgery on the carotid arteries less than 1 year before screening. 7. History of stroke less than 1 year before screening. 8. Myocardial infarction less than 6 months before screening. 9. Chronic renal failure stage 2-3 (creatinine clearance less than 40 ml/min). 10. Pregnancy or lactation. 11. Participation in another trial within 28 days prior to enrollment. 12. Use of prohibited medications.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07167550 clinical trial?
This trial is open to participants of all sexes, aged 35 Years or older, up to 80 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07167550 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 184 participants.
Is NCT07167550 currently recruiting?
Yes, NCT07167550 is actively recruiting participants. Contact the research team at iksanova@tatpharm.ru for enrollment information.
Where is the NCT07167550 trial being conducted?
This trial is being conducted at Vsevolozhsk, Russia, Krasnodar, Russia, Moscow, Russia, Moscow, Russia and 2 additional locations.
Who is sponsoring the NCT07167550 clinical trial?
NCT07167550 is sponsored by Tatchempharmpreparaty, JSC. The trial plans to enroll 184 participants.
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