It was a randomised, placebocontrolled, sequential trial in patients with moderate to. Three years ago, the results of the ictus trial, made in europe were published, with an overall neutral result because the circumstances of the study 46% patients treated with rtpa, median. We can interpret the results of the ictus trial as a dilution of the effect of the drug in parallel with the improvement of the standard of care, thus, patients. Dari hasil penelitian tersebut, munculah keraguan apakah sebenarnya citicoline sebaiknya digunakan untuk penderita stroke atau tidak. We can interpret the results of the ictus trial as a dilution of the effect of the drug in parallel with the improvement of the standard of care, thus, patients treated with rtpa in a stroke unit, could not need an additional treatment with citicoline. Contributors ad, jas, jc, edt, jf, emv, ec, and jjs contributed equally in the study design, data analysis, data interpretation, and writing the report.
Jul 28, 2012 citicoline in the treatment of acute ischaemic stroke. International citicoline trial on acute stroke ictus. Early invasive versus selectively invasive management for. Mechanisms and stroke clinical trials rao muralikrishna adibhatla, j. However, in the ictus trial the numbers and types of adverse events and serious adverse events, including neurological events, were similar in the two groups. Some other factors could have reduced the sensitivity of the ictus trial eg, poor treatment compliance. Citicoline provides no benefit in acute ischemic stroke. The role of citicoline in neuroprotection and neurorepair in. A single clinical trial ficdpchic, which is a pilot, doubleblind, randomized, placebocontrolled trial, has used citicoline in patients with hemorrhagic stroke. Davalos a1, alvarezsabin j, castillo j, dieztejedor e, ferro j, martinezvila e, serena j, segura t, cruz vt, masjuan j, cobo e, secades jj.
Citicoline did not improve recovery at 90 days after. With advances in medical therapy and higher rates of revascularization. Evaluation of a sequential global test of improved. Previous studies showed some evidence of benefit with citicoline 1. In conclusion, under the circumstances of the ictus trial, citicoline is safe but is not efficacious in the treatment of moderatetosevere acute ischaemic stroke. Dempsey department of neurological surgery university of wisconsin, madison, wi 53792. The effects of citicoline on acute ischemic stroke. Sep 23, 20 the international citicoline trial on acute stroke, ictus was designed to confirm the encouraging results of the data pooling analyses and to replicate those trends. Early application of citicoline in the treatment of acute. International citicoline trial on acute stroke enrolled 2298 patients with moderatetosevere strokes within 24 hours of stroke onset. This was the international citicoline trial on acute ischemic stroke, the ictus trial 505506507 508. Also in the ictus trial, it was hypothesized that the bene. Three years ago, the results of the ictus trial, made in europe were published, with an overall neutral result because the circumstances of the study 46% patients treated with rtpa, median nihss 15 and bigger infarcts not excluded, concluding that on top of the best treatment possible, citicoline does not show any clinical improvement but.
The primary objective of the trial is to demonstrate improved recovery of patients randomized to citicoline relative to those randomized to placebo after 12 weeks of followup. How effective is citicoline for acute ischaemic stroke. The international citicoline trial on acute stroke, ictus was designed to confirm the encouraging results of the data pooling analyses and to replicate. The primary analysis will take the form of a global test combining the dichotomized results of assessments on three wellestablished scales. Jan 29, 20 citicoline in the treatment of acute ischaemic stroke.
Cobrit citicoline brain injury treatment trial, performed on 1,2 patients to treat traumatic brain injury 9, and the ictus international citicoline trial on acute stroke trial, performed in 2,298 patients to treat moderatetosevere acute ischemic stroke 8. It analyzes the results of the ictus trial in which 2298 patients with is who received randomly citicoline or placebo for 24 hours after the onset of symptoms i000 mg intravenously every i2. The ictus trial invasive versus conservative treatment in unstable coronary syndromes trial evaluated early invasive versus initial conservative therapy during nstemi or unstable angina. Treatment of citicoline within the first 24 hours after onset in patients with moderate to severe stroke increases the probability of complete recovery in 3 months. The therapeutic action of citicoline is thought to be due to stimulation of. Citicoline in the treatment of acute ischaemic stroke. Citicoline has been studied as a potential neuroprotective and neurorestorative agent in ischemic stroke for almost 25 years. Jul 21, 2008 the primary objective of the trial is to demonstrate improved recovery of patients randomized to citicoline relative to those randomized to placebo after 12 weeks of follow. Dempsey department of neurological surgery university of wisconsin, madison, wi 53792 we read with interest the article on citicoline phase iii clinical studies 1. Vitor t cruz, jaime masjuan, erik cobo, julio j secades, for the international citicoline trial on acute stroke ictus trial investigators summary background citicoline is approved in some countries for the treatment of acute ischaemic stroke. Pdf evaluation of a sequential global test of improved.
A randomized efficacy trial of citicoline in patients with acute ischemic stroke. Sep 18, 2012 citicoline has been studied as a potential neuroprotective and neurorestorative agent in ischemic stroke for almost 25 years. International citicoline trial on acute stroke ictus the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. The ictus trial showed that citicoline is not effective in the treatment of moderatetosevere acute ischemic stroke. Uses, side effects, interactions, dosage, and warning. The primary outcome was recovery at 90 days measured by a global test combining three measuresnih stroke. The ictus trial suggests that selectively invasive management may be an acceptable alternative approach to treatment.
A large randomized trial failed to confirm any efficacy of citicoline in improving global recovery after acute ischemic stroke, although a few subgroups appeared to benefit. A comparative study of citicoline vs cerebroprotein. A randomized efficacy trial of citicoline in patients with. In the lancet, davalos et al 29 report the results of the international citicoline trial on acute stroke ictus, where the possible beneficial effect of citicoline for protection and repair of the brain from the ischemic injury was tested in patients with ais. Citicoline in the treatment of acute ischaemic stroke red heracles. The drug has shown some evidence of efficacy in a pooled analysis, based on four clinical trials done in usa with oral citicoline. The citicoline brain injury treatment trial cobrit, conducted in united states, is a randomized, doubleblind, placebocontrolled, multicenter trial to analyze the effects of 90 days of citicoline mg twice per day or placebo on functional outcome in patients with complicated mild, moderate, or severe traumatic brain injury. The citicoline brain injury treatment trial cobrit, a phase 3, doubleblind randomized clinical trial conducted between july 20, 2007, and february 4, 2011, among 12 patients at 8 us level 1. When the ictus results are added to the previous trials of citicoline, the summary. An international, randomised, multicentre, placebocontrolled study ictus trial citicoline. Cdpcholine supplement health benefits, dosage, side. The international citicoline trial on acute stroke, ictus was designed to confirm the encouraging results of the data pooling analyses and to replicate those trends. It analyzes the results of the ictus trial in which 2298 patients with is who received randomly citicoline or placebo for 24 hours after the onset.
Introduction stroke remains one of the most devastating diseases, often causing death or gross physical impairment or disability. Listing a study does not mean it has been evaluated by the u. Citicoline, also known as cytidine diphosphatecholine cdpcholine or cytidine 5diphosphocholine is an intermediate in the generation of phosphatidylcholine from choline, a. Cdpcholine citicoline is a nootropic compound that converts to both choline and cytidine upon ingestion, the latter of which converts into uridine in the body. Interpretation under the circumstances of the ictus trial, citicoline is not effi. The citicoline brain injury treatment cobrit trial. Ictus was an international, multicenter, prospective, doubleblind, randomized, placebocontrolled trial with participation of neurology services from 37 centers in spain, 11 in. Citicoline did not improve recovery at 90 days after moderatetosevere acute ischemic stroke davalos a, alvarezsabin j, castillo j, et al. Treatment for acute strokethe end of the citicoline saga. International citicoline trial on acute stroke full text. The ictus trial stated that that administration of citicoline was safe but did not provide evidence that it is efficacious in the treatment of moderatetosevere acute ischemic stroke. Rationale for the use of citicoline in the management of. Objectives we present the 5year clinical outcomes according to treatment strategy with additional risk stratification of the ictus invasive versus conservative. In a clinical trial, citicoline accelerated the recovery from post.
Request pdf citicoline in the treatment of acute ischaemic stroke. Background longterm outcomes may be relevant to decide treatment strategy for patients presenting with nonstsegment elevation acute coronary syndromes nsteacs and elevated. The primary analysis will take the form of a global test combining the dichotomized results of assessments on three well. International citicoline trial on acute stroke trial. Randomized controlled trials published until may 2015 were electronically searched in medline, embase, the cochrane central register of controlled trials, who international clinical trial registration platform, clinical trial. The role of citicoline in neuroprotection and neurorepair. The international citicoline trial on acute stroke, ictus 60 was designed to confirm the encouraging results of the data. In this trial, patients with moderate to severe acute ischaemic stroke were treated with either citi coline or. In the lancet, davalos et al 29 report the results of the international citicoline trial on acute stroke ictus, where the possible beneficial effect of citicoline for protection and repair of the. In humans, although a recent trial international citicoline trial on acute stroke ictus has shown that. This study was to evaluate the efficacy and safety of early application of citicoline in the treatment of patients with acute stroke by metaanalysis.
The ictus fulfilled the criteria for a therapy, which can be offered to all ischemic. The welldesigned and executed ictus study is the largest and most recent trial to investigate citicoline. International citicoline trial on acute stroke ictus, where the. Citicoline in stroke and tbi clinical trials nature. International citicoline trial on acute stroke nct00331890 oral citicoline in acute ischemic stroke. Interpretation under the circumstances of the ictus trial, citicoline is not e. In any case, the ictus trial has been unable to confirm the efficacy of citicoline. The primary objective of the trial is to demonstrate improved recovery of patients randomized to citicoline relative to those randomized to placebo after 12 weeks of follow. Despite some suggestions that citicoline may reduce the rates of death and disability following an ischemic stroke, the largest citicoline clinical trial to date, a randomised, placebocontrolled, sequential trial in patients with moderatetosevere acute ischaemic stroke in europe, enrolling 2298 patients, found no benefit of administering.
The citicoline brain injury treatment trial cobrit, a phase 3, doubleblind randomized clinical trial conducted between july 20, 2007, and february 4, 2011, among 12 patients at 8 us level. With advances in medical therapy and higher rates of revascularization, patients treated with the selectively invasive strategy showed no difference in the cumulative rate of death, nonfatal myocardial infarction, or. International citicoline trial on acute stroke trial investigators ictus. Patients for the trial were selected on the basis of eligibility criteria see table 1 from 31 stroke centers in the united states see appendix. Brain uptake of table 1 recent studies since 1995 investigating the action of citicoline in neuropathological conditions study effectoutcome reference transient forebrain ischemiagerbil. We postulate that citicolines neuroprotective effects should need a longer time of administration. Ictus was an international, multicenter, prospective, doubleblind, randomized, placebocontrolled trial with participation of neurology services from 37. This trial was a randomized, doubleblind, placebocontrolled efficacy study of 500 mg of oral citicoline in patients with acute ischemic stroke. Apr, 2016 this study was to evaluate the efficacy and safety of early application of citicoline in the treatment of patients with acute stroke by metaanalysis.
Penelitian yang dilakukan oleh international citicoline trial on acute stroke ictus mengemukakan bahwa pemakaian citicoline tidak memberikan hasil yang bermanfaat bagi. Background current guidelines recommend an early invasive strategy for patients who have acute coronary syndromes without stsegment elevation and with an elevated cardiac troponin t level. Citicoline did not improve recovery at 90 days after moderate. Investigation of the potential of citicoline in stroke treatment has continued, and the results of a large trial have recently been published in the lancet. Full text the role of citicoline in cognitive impairment. In humans, although a recent trial international citicoline trial on acute stroke ictus has shown that global recovery is similar in cdp. In this trial, patients with moderate to severe acute ischaemic stroke were treated with either citi coline or placebo within 24 h after symptom onset.