Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:21 PM
Ignite Modification Date:
2025-12-24 @ 7:21 PM
NCT ID:
NCT05154903
Eligibility Criteria:
Inclusion Criteria:
* \- Both genders aged \> 18 years.
* Patients must be treated within 24 hours of their initial stroke symptoms onset.
* Patients not eligible to receive rTPA.
* Patients with a measurable focal neurological deficit (NIHSS score ≥ 8) lasting for a minimum of 60 minutes. This deficit must persist from onset and up to the time of treatment without clinically significant improvement
* Patients must have a CT scan and/or conventional MRI compatible with the clinical diagnosis of acute ischemic stroke prior to being randomized.
* Patients must have an acute ischemic stroke with symptoms referrable to internal carotid territory.
* At inclusion, NIHSS score 8-15, with at least 2 of these points from sections 5 \& 6 (motor).
* Immediately (i.e. minutes) pre-stroke, mRS ≤ 1. \[History of past stroke does not, by itself, preclude study entrance\].
* Women of childbearing potential must have a negative pregnancy test prior to enrolment.
* Signed informed consent (following a full explanation of the nature and purpose of this study, the patient or legal guardian(s) or representative(s) must consent to participate by signing the Informed Consent document
Exclusion Criteria:
* Patients eligible for rTPA treatment.
* Patients in coma: patients having a score of 2 or higher in the items regarding the level of consciousness in the NIHSS (1a).
* CT or conventional MRI evidence of any structural brain disorder other than ischemic stroke.
* History of ventricular dysrhythmias, acute myocardial infarction within 72 hours prior to 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.
* 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 an score of 2 or higher in the previous mRS.
* Pre-existing medical condition that, in the Investigator's opinion, may interfere with the patient's suitability and participation in the study.
* Patients participating in another clinical trial or receiving a non-approved drug (clinical investigational drug) less than 30 days prior to screening.
* Patients under current treatment with citicoline.
* Prior (over past 3 months) or concomitant administration of other neuroprotectant drugs (such as nimodipine, vinponcetine, piracetam, cerebrolysin,…).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05154903
Study Brief:
Protocol Section:
NCT05154903