NCT06210646CompletedPhase 3
Citicoline in Ischemic Stroke, a Randomized Trial
Citicoline in Ischemic Stroke, a Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 19 Sept 2024
Brief summary (registry, in English)
Along with the current clinical trial, the efficacy and safety of a 2000 mg daily citicoline administered within 24 hours of the first-ever ischemic stroke and lasted 12 months compared to 1000 mg were assessed through MoCA, NIHSS, mRS, and possible adverse effects.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 800 (actual)
- First submitted
- 7 Jan 2024
- Start date
- 29 Dec 2022
- Primary completion date
- 29 Jun 2024
- Lead sponsor
- Kafrelsheikh University
- Diseases
- Stroke
- NCT number
- NCT06210646
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 800
- From 29 Dec 2022 to the primary completion date, 29 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous disorders that may confound the interpretation of the neurological scales.
- Pre-existing dementia, when dementia implies a disability, measured as a score of 2 or higher in the previous mRS.
- Patients under current treatment with citicoline.
- concomitant administration of other neuroprotectant drugs (such as nimodipine, vinpocetine, piracetam, cerebrolysine).
Other illness
- CT or conventional MRI evidence of any structural brain disorder other than ischemic stroke.
- History of ventricular dysrhythmias, acute myocardial infarction within 72 hours before enrolment, unstable angina, decompensated congestive heart failure, or any other acute, severe, uncontrollable, or sustained cardiovascular condition that, in the Investigator's opinion, may interfere with effective participation in the study.
- Drug addiction-related disorders.
Other
- Patients eligible for rTPA treatment.
- Patients with any type of aphasia
- Patients in coma: patients having a score of 2 or higher in the items regarding the level of consciousness in the NIHSS.
Who the study is looking for
- Male \& female patients will be included
- Age more than 18 years.
- Patients must be treated within the first 24 hours of their initial stroke symptoms onset.
- Patients not eligible to receive TPA.
- Patients with a measurable focal neurological deficit (NIHSS score ≥ 4 and less than 21) lasting at least 60 minutes.This deficit must persist from the onset and up to the time of treatment without clinically significant improvement
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kafr-Elsheikh University Hospital Coordinator of this site? Confirm its status | Kafr ash Shaykh | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.