Citicoline in Ischemic Stroke, a Randomized Trial

NCT06210646 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2024-09-19

No results posted yet for this 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.

Conditions

Interventions

DRUG

Citicoline 2000

The citicoline arm consists of 400 patients who received 2000 mg citicoline once daily for 12 months, and an 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.

DRUG

citocoline 1000

The placebo arm consists of 400 patients who received a citicoline 1000 mg once daily for 12 months, an 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.

Sponsors & Collaborators

  • Kafrelsheikh University

    lead OTHER

Principal Investigators

  • mohamed G. Zeinhom, MD · neurology department kafr el-sheikh university

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-29
Primary Completion
2024-06-29
Completion
2024-06-29
FDA Drug
Yes

Countries

  • Egypt

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06210646 on ClinicalTrials.gov