ICTUS
International Citicoline Trial on Acute Stroke
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Status:
Ongoing. Enrollment began November 2006. As of August 2009, 1099 are enrolled at 27 active centers in Spain, 8 in Portugal, and 10 in Germany. The study will follow a sequential analysis, with the first approach to test the efficacy with 1000 patients. The upper limit has been established in 2600 patients. At this moment we have 1099 patients recruited and we are opening 1 new centre in Germany, 3 in Spain and 2 in Portugal. The first interim analysis, planned when the first 1000 patients finish the study, has been dated for the next DSMB meeting early november.
Purpose:
To confirm the results obtained in the pooled analysis
Interventions:
Citicoline
Phosphatidylcholine precursor, membrane stabilizer (cytidyl diphosphocholine)
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Location(s):
Spain, Portugal, Germany.
Year Started:
2006
Design:
A multicenter, prospective, randomized, double-blind, placebo-controlled study (Update at 4th May 2009)
Inclusion Criteria
Stroke patients with a measurable focal neurological deficit lasting for a minimum of 60 minutes; baseline NIHSS score ≥ 8, with a neuroimage compatible with the diagnosis of acute ischemic stroke and symptoms referable to MCA territory; pre-stroke mRS ≤ 1.
Exclusion Criteria
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 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; history of ventricular dysrhythmias, acute myocardial infarction within 72 hours prior to enrollment, 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 .
Patient Involvement:
Patients will be randomized in a 1:1 ratio to receive either citicoline or placebo. Citicoline forms: 1000 mg ampoules (4 cc) and 500 mg tablets. Daily dosage: 1000 mg/12 h i.v. during the first three days and orally from the fourth day until the end of the 6 weeks treatment period.
Primary Outcome:
Recovery at 3 months will be evaluated using a primary end-point incorporating 3 components: neurological (NIHSS) ≤ 1), disability (MRS ≤ 1), and activities of daily life (BI ≥ 95), averaged using GEE.
Secondary Outcome:
Single scales at week 12.
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Source of Information:
ClinicalTrials.gov
Presented at the 2006 International Stroke Conference [February 2006].
Presented at the 2006 ESC.
Presented at the 2007 International Stroke Conference [February 2007].
Presented at the 2007 ESC
Presented at the 2008 International Stroke Conference (February 2008).
Presented at the 2008 European Stroke Conference (May 2008)
Presented at the 2009 International Stroke Conference (February 2009)
Presented at the 2009 European Stroke Conference (May 2009)
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Web Links and Publications:
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This information last updated on: 8/14/2009
Reviewed on: 07/01/2009.
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