Citicoline in Ischemic Stroke, a Randomized Trial

Ischemic Stroke Clinical Trial

Official title: Citicoline in Ischemic Stroke, a Randomized Placebo-controlled Trial

Status Recruiting

Clinical Trial Summary

Along with the current clinical trial, the efficacy and safety of a 1000 mg daily citicoline administered within 24 hours of the first-ever ischemic stroke and lasted 12 months compared to placebo were assessed through MoCA, NIHSS, mRS, and possible adverse effects.

Clinical Trial Description

The investigators conducted a single-blinded, placebo-controlled, randomized controlled trial between December 2023 and December 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 1000 mg citicoline once daily for 12 months, and the placebo arm, consisting of 400 patients who received a placebo 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. ;

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

• NCT number: NCT06210646
• Study type: Interventional
• Source: Kafrelsheikh University
• Contact: mohamed G Zeinhom, MD
• Phone: 2001009606828
• Email: mohamed_gomaa@med.kfs.edu.eg
• Status: Recruiting
• Phase: Phase 3
• Start date: December 29, 2023
• Completion date: December 29, 2024