Citicoline in the treatment of acute ischaemic stroke: An international, randomised, multicentre, placebo-controlled study (ICTUS trial)

The Lancet

Volumn 380, Issue 9839, 2012, Pages 349-357

  Dávalos, Antoni ^a   Alvarez Sabín, José ^b   Castillo, José ^c   Díez Tejedor, Exuperio ^d   Ferro, Jose ^e   Martínez Vila, Eduardo ^f   Serena, Joaquín ^g   Segura, Tomás ^h   Cruz, Vitor T ⁱ   Masjuan, Jaime ^j   Cobo, Erik ^k   Secades, Julio J ^l  

^a HOSPITAL UNIVERSITARI GERMANS TRIAS I PUJOL   (Spain)

^b HOSPITAL UNIVERSITARI VALL D HEBRON   (Spain)

^c Instituto de Salud Carlos III   (Spain)

^d HOSPITAL UNIVERSITARIO LA PAZ   (Spain)

^e HOSPITAL DE SANTA MARIA   (Portugal)

^f UNIVERSITY CLINIC OF NAVARRA   (Spain)

^g HOSPITAL JOSEP TRUETA   (Spain)

^h HOSPITAL GENERAL UNIVERSITARIO DE ALBACETE   (Spain)

ⁱ Hospital So Sebastio   (Portugal)

^j HOSPITAL RAMÓN Y CAJAL   (Spain)

^k UNIVERSITAT POLITÈCNICA DE CATALUNYA   (Spain)

^l Ferrer Grupo Research Center   (Spain)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ALTEPLASE; CITICOLINE; PLACEBO;

AGED; AGITATION; ARTICLE; BARTHEL INDEX; BRAIN HEMORRHAGE; BRAIN ISCHEMIA; CONSTIPATION; CONTROLLED STUDY; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG INDUCED HEADACHE; DRUG SAFETY; FEMALE; FEVER; HEART DISEASE; HUMAN; HYPOTENSION; INFORMED CONSENT; MAJOR CLINICAL STUDY; MALE; MORTALITY; MULTICENTER STUDY; NATIONAL INSTITUTES OF HEALTH STROKE SCALE; NAUSEA AND VOMITING; NEUROLOGIC DISEASE; PATIENT SAFETY; PNEUMONIA; PRIORITY JOURNAL; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL; RANKIN SCALE; SIDE EFFECT; SPAIN; URINARY TRACT INFECTION;

EID: 84864277207     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(12)60813-7     Document Type: Article

References (24)

1. Mukherjee D, Patil CG. Epidemiology and the global burden of stroke. World Neurosurg 2011; 76 (suppl): S85-90.
2. Feigin VL, Lawes CM, Bennett DA, Anderson CS. Stroke epidemiology: a review of population-based studies of incidence, prevalence, and case-fatality in the late 20th century. Lancet Neurol 2003; 2: 43-53. (Pubitemid 37443343)
3. Labiche LA, Grotta JC. Clinical trials for cytoprotection in stroke. NeuroRx 2004; 1: 46-70. (Pubitemid 46591882)
4. Lees KR, Bluhmki E, von Kummer R, et al, and the ECASS, ATLANTIS, NINDS and EPITHET rt-PA Study Group. Time to treatment with intravenous alteplase and outcome in stroke: an updated pooled analysis of ECASS, ATLANTIS, NINDS, and EPITHET trials. Lancet 2010; 375: 1695-703.
5. Sahota P, Savitz SI. Investigational therapies for ischemic stroke: neuroprotection and neurorecovery. Neurotherapeutics 2011; 8: 434-51.
6. Saver JL. Target brain: neuroprotection and neurorestoration in ischemic stroke. Rev Neurol Dis 2010; 7 (suppl 1): S14-21.
7. Gutierrez-Fernandez M, Rodriguez-Frutos B, Fuentes B, et al. CDP-choline treatment induces brain plasticity markers expression in experimental animal stroke. Neurochem Int 2012; 60: 310-17.
8. Secades JJ. Citicoline: pharmacological and clinical review, 2010 update. Rev Neurol 2011; 52 (suppl 2): S1-62.
9. Clark WM, Warach SJ, Pettigrew LC, Gammans RE, Sabounjian LA, and the Citicoline Stroke Study Group. A randomized dose-response trial of citicoline in acute ischemic stroke patients. Neurology 1997; 49: 671-78. (Pubitemid 27428003)
10. Clark WM, Williams BJ, Selzer KA, Zweifl er RM, Sabounjian LA, Gammans RE. A randomized efficacy trial of citicoline in patients with acute ischemic stroke. Stroke 1999; 30: 2592-97.
11. Clark WM, Wechsler LR, Sabounjian LA, Schwiderski UE, and the Citicoline Stroke Study Group. A phase III randomized efficacy trial of 2000 mg citicoline in acute ischemic stroke patients. Neurology 2001; 57: 1595-602. (Pubitemid 33055476)
12. Davalos A, Castillo J, Alvarez-Sabin J, et al. Oral citicoline in acute ischemic stroke: an individual patient data pooling analysis of clinical trials. Stroke 2002; 33: 2850-57. (Pubitemid 35462855)
13. Saver JL. Citicoline: update on a promising and widely available agent for neuroprotection and neurorepair. Rev Neurol Dis 2008; 5: 167-77.
14. Hacke W, Kaste M, Fieschi C, et al, and the Second European-Australasian Acute Stroke Study Investigators. Randomised double-blind placebo-controlled trial of thrombolytic therapy with intravenous alteplase in acute ischaemic stroke (ECASS II). Lancet 1998; 352: 1245-51. (Pubitemid 28470336)
15. Cobo E, Secades JJ, Miras F, et al. Boosting the chances to improve stroke treatment. Stroke 2010; 41: e143-50.
16. Bolland K, Whitehead J, Cobo E, Secades JJ. Evaluation of a sequential global test of improved recovery following stroke as applied to the ICTUS trial of citicoline. Pharm Stat 2009; 8: 136-49.
17. Tissue plasminogen activator for acute ischemic stroke. The National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. N Engl J Med 1995; 333: 1581-87.
18. Whitehead J, Branson M, Todd S. A combined score test for binary and ordinal endpoints from clinical trials. Stat Med 2010; 29: 521-32.
19. Whitehead J. Group sequential trials revisited: simple implementation using SAS. Stat Methods Med Res 2011; 20: 635-56.
20. Wang R, Lagakos SW, Ware JH, Hunter DJ, Drazen JM. Statistics in medicine-reporting of subgroup analyses in clinical trials. N Engl J Med 2007; 357: 2189-94.
21. Warach S, Pettigrew LC, Dashe JF, et al. Effect of citicoline on ischemic lesions as measured by diffusion-weighted magnetic resonance imaging. Ann Neurol 2000; 48: 713-22.
22. Tazaki Y, Sakai F, Otomo E, et al. Treatment of acute cerebral infarction with a choline precursor in a multicenter double-blind placebo controlled study. Stroke 1988; 19: 211-16. (Pubitemid 18084395)
23. Rother J. Neuroprotection does not work! Stroke 2008; 39: 523-24. (Pubitemid 351619490)
24. Hermann DM, Chopp M. Promoting brain remodelling and plasticity for stroke recovery: therapeutic promise and potential pitfalls of clinical translation. Lancet Neurol 2012; 11: 369-80.