Citicoline in the treatment of acute ischemic stroke. An international randomized multicenter placebo-controlled study.Citicolina en el tratamiento del ictus isquémico agudo. Estudio internacional, multicéntrico. aleatorizado y controlado por placebo. - ICTUS

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 2600

Inclusion Criteria

1.Male or female, =18 years old.
2.Patients must be treated within 24 hours of their initial stroke symptoms onset. The time between hospital admittance and randomization must be inferior or equal to 3 hours and the time between randomization and the administration of the first dose must be inferior or equal to 1 hour. In the case of inpatients suffering a stroke (in-hospital stroke), the hospital arrival time will be the time of symptoms onset. In the case of unknown time of symptoms onset (i.e. awake stroke), the time of stroke onset will be considered as the last time when the patient was asymptomatic.
3.Patients with a measurable focal neurological deficit lasting for a minimum of 60 minutes. This deficit must persist from onset and up to the time of treatment without clinically significant improvement (independent of the use of rTPA). At the inclusion, patient must have a NIHSS score = 8.
4.Patients must have a CT scan and/or conventional MRI compatible with the clinical diagnosis of acute ischemic stroke prior to being randomized.
5.Patients must have an acute ischemic stroke with symptoms, on clinical examination, suggestive of a stroke referable to the middle cerebral artery territory.
6.At inclusion, NIHSS score = 8, with at least 2 of these points from sections 5 & 6 (motor).
7.Immediately (i.e. minutes) pre-stroke, MRS £ 1 (no symptoms at all, or no significant disability despite symptoms; able to carry out all usual duties and activities). [History of past stroke does not, by itself, preclude study entrance].
8.Women of childbearing potential must have a negative pregnancy test prior to enrolment.
9.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).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Patients in coma: patients having a score of 2 or higher in the items regarding the level of consciousness in the NIHSS (1a).
2.CT or conventional MRI evidence of brain tumor, cerebral edema with a clinically significant mass midline shift with compression of the ventricles, brainstem or cerebellar infarction, subarachnoid and/or intracerebral and/or intraventricular hemorrhage.
3.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.
4.Previous disorders that may confound the interpretation of the neurological scales.
5.Drug addiction-related disorders.
6.Pre existing dementia, when dementia implies a disability, measured as an score of 2 or higher in the previous MRS.
7.Pre existing medical condition that, in the Investigator’s opinion, may interfere with the patient's suitability and participation in the study.
8.Patients participating in another clinical trial or receiving a non-approved drug (clinical investigational drug) less than 30 days prior to screening.
9.Patients under current treatment with citicoline.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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