Citicoline in Ischemic Stroke, a Randomized Trial

Last updated: September 5, 2024
Sponsor: Kafrelsheikh University
Overall Status: Completed

Phase

3

Condition

Cerebral Ischemia

Thrombosis

Blood Clots

Treatment

Citicoline

Citicoline 2000

Placebo

Clinical Study ID

NCT06210646
2391988
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male & female patients will be included

  • Age more than 18 years.

  • Patients must be treated within the first 24 hours of their initial stroke symptomsonset.

  • Patients not eligible to receive TPA.

  • Patients with a measurable focal neurological deficit (NIHSS score ≥ 4 and less than

  1. lasting at least 60 minutes.This deficit must persist from the onset and up tothe time of treatment without clinically significant improvement

Exclusion

Exclusion Criteria:

  • 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 thelevel of consciousness in the NIHSS.

  • CT or conventional MRI evidence of any structural brain disorder other than ischemicstroke.

  • History of ventricular dysrhythmias, acute myocardial infarction within 72 hoursbefore enrolment, unstable angina, decompensated congestive heart failure, or anyother acute, severe, uncontrollable, or sustained cardiovascular condition that, inthe Investigator's opinion, may interfere with effective participation in the study.

  • Previous disorders that may confound the interpretation of the neurological scales.

  • Drug addiction-related disorders.

  • Pre-existing dementia, when dementia implies a disability, measured as a score of 2or higher in the previous mRS.

  • Patients under current treatment with citicoline.

  • concomitant administration of other neuroprotectant drugs (such as nimodipine,vinpocetine, piracetam, cerebrolysine).

Study Design

Total Participants: 800
Treatment Group(s): 4
Primary Treatment: Citicoline
Phase: 3
Study Start date:
December 29, 2022
Estimated Completion Date:
June 29, 2024

Study Description

The investigators conducted a single-blinded, placebo-controlled, randomized controlled trial between December 2022 and June 2024 after approval of the ethical committee of the faculty of medicine at Kafr el-Sheik University.

The investigators got written informed consent from all eligible patients or their first order of kin before randomization.

The study will comprise 2 arms citicoline arm, which consists of 400 patients who received 2000 mg citicoline once daily for 12 months, and the placebo arm, consisting of 400 patients who received 1000 mg citicoline once daily for 12 months; all the patients in the two groups received open-label double antiplatelet in the form of 75 mg aspirin. And 75 mg clopidogrel for three weeks, followed by a single antiplatelet in the form of 75 mg clopidogrel for the rest of our trial.

Study Procedures:

Every patient in our study will undergo:

Clinical workup: History, clinical assessment & NIHSS, and the Modified Rankin Scale and MoCA scale were recorded at baseline and then after 3 months, 6 months, and 12 months as a follow-up

Detection of Risk Factors & Profiles:

Echocardiography TTE: in indicated patients ECG Monitoring: daily ECG monitoring will be performed in indicated patients. 3- Carotid Duplex: carotid duplex in indicated patients.

4- ESR & Lipid Profile& liver functions: All will be tested routinely for all patients.

Imaging Follow UP Non-contrast CT brain on admission and MRI (stroke protocol; T1W, T2W, FLAIR, DWI, T2 Echo Gradient, MRA of all intra-cerebral vessels).

CT brain: Any patient with unexplained clinical deterioration at any time throughout his/her hospital stay will be urgently imaged by CT.

Primary End Point:

The primary efficacy outcome was the MoCA score after 6 months; the primary safety outcome was the rate of treatment-related adverse effects assessed by a follow-up questionnaire after 6 months.

• Secondary End Point: the secondary efficacy outcomes were: the MoCA after 12 months, mRS after 6 months, and mRS after 12 months, and the secondary safety outcome was the rate of treatment-related adverse effects assessed by a follow-up questionnaire after 12 months.

Connect with a study center

  • Kafr Elsheikh University Hospital

    Kafr Ash Shaykh, 33511
    Egypt

    Site Not Available

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