Study Stopped
With 2078 patients, a statistical stopping boundary has now been crossed
ICTUS Study: International Citicoline Trial on Acute Stroke
ICTUS
Citicoline in the Treatment of Acute Ischemic Stroke. An International Randomized Multicenter Placebo-controlled Study
1 other identifier
interventional
2,298
3 countries
65
Brief Summary
Citicoline is a safe drug approved in some countries for the treatment of acute ischemic stroke. The drug has shown some evidence of efficacy in a pooled analysis, based on four clinical trials done in USA with oral citicoline.The purpose of the study is confirm the results obtained in the pooled analysis, that is, evidence of efficacy in the treatment of acute ischemic stroke
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2006
Longer than P75 for phase_3
65 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2006
CompletedFirst Posted
Study publicly available on registry
May 31, 2006
CompletedStudy Start
First participant enrolled
October 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedJune 20, 2012
June 1, 2012
5.3 years
May 30, 2006
June 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total recovery at three months of onset, based on a global test analysis including NIHSS, mRS and Barthel Index
3 months
Secondary Outcomes (3)
mRS at 3 months
3 months
Barthel Index at 3 months
3 months
Safety and tolerability
3 months
Study Arms (2)
Active
EXPERIMENTALReceives active drug
Placebo
PLACEBO COMPARATORReceives a placebo
Interventions
1g/12h iv during 3 days and then orally until complete 6 weeks of treatment
Eligibility Criteria
You may qualify if:
- Male or female, \>18 years old
- Patients must be treated within 24 hours of their initial stroke symptoms onset.
- Patients with a measurable focal neurological deficit lasting for a minimum of 60 minutes.
- 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 referable to the middle cerebral artery territory
- Immediately (i.e. minutes) pre-stroke, MRS \< 2
- Women of childbearing potential must have a negative pregnancy test prior to enrolment
- Signed informed consent
You may not qualify if:
- 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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (65)
Klinikum AltenburgerLand GmbH
Altenburg, 4600, Germany
Neurologie EVKB
Bielefeld, 33617, Germany
Neurologische Klinik Heinrich-Heine Universität
Düsseldorf, 40225, Germany
Universitätsklinikum Erlangen
Erlangen, 91054, Germany
Ernst-Moritz-Arndt-Universität Greifswald
Greifswald, 17489, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246, Germany
Neurologische Klinik Universitatsklinikum Heidelberg
Heidelberg, 69120, Germany
Klinikum Ingolstadt
Ingolstadt, 85049, Germany
Universitätsklinikum Leipzig
Leipzig, 04103, Germany
Johannes Wesling Klinikum Minden
Minden, 32429, Germany
Klinikum Großhadern der Universität München
München, 81377, Germany
Universitätsklinikum Münster
Münster, 48149, Germany
Hospital de Sao Jose
Lisbon, Lisbon District, 1150-119, Portugal
Hospital de Sao Joao
Porto, Porto District, 4202-451, Portugal
Hospital Garcia de Orta, EPE
Almada, 2801-951, Portugal
Hospital Garcia de Orta
Almada, Portugal
Hospital Fernando Fonseca
Amadora - Sintra, 2720-276, Portugal
Hospital Sao Marcos
Braga, 4700-308, Portugal
Hospitais da Universidade Coimbra
Coimbra, 3000-075, Portugal
Centro Hospitalar de Coimbra
Coimbra, 3040-324, Portugal
Hospital de Santa Maria
Lisbon, 1649-028, Portugal
Hospital de Santo Antonio
Porto, 4099-001, Portugal
Hospital Sao Sebastiao
Santa Maria da Feira, 4520-211, Portugal
Centro Hospitalar de Setúbal, EPE
Setúbal, 2910-446, Portugal
Centro Hospitalar de Setúbal
Setúbal, Portugal
Hospital Sao Pedro
Vila Real, 5000-508, Portugal
Hospital General de Albacete
Albacete, Albacete, 02006, Spain
Hospital Son Dureta
Palma de Mallorca, Balearic Islands, 07014, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital del Mar
Barcelona, Barcelona, 08003, Spain
Hospital de la Santa Creu I Sant Pau
Barcelona, Barcelona, 08025, Spain
Hospital Sagrat Cor
Barcelona, Barcelona, 08029, Spain
Hospital Vall d´Hebron
Barcelona, Barcelona, 08035, Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital de Mataro
Mataró, Barcelona, 08304, Spain
Consorci Hospitalari Parc Tauli
Sabadell, Barcelona, 08208, Spain
Hospital Moises Broggi
Sant Joan Despí, Barcelona, 08970, Spain
Hospital General Yague
Burgos, Burgos, 09005, Spain
Hospital San Pedro de Alcantara
Cáceres, Caceres, 10003, Spain
Hospital de Girona Dr. Josep Trueta
Girona, Girona, 17007, Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela, La Coruña, 15706, Spain
Hospital de Leon
León, Leon, 24071, Spain
Hospital Arnau de Vilanova
Lleida, Lleida, Spain
Complejo Hospitalario Xeral Calde
Lugo, Lugo, 27004, Spain
Hospital de La Princesa
Madrid, Madrid, 28006, Spain
Hospital Universitario Gregorio Marañon
Madrid, Madrid, 28007, Spain
Hospital Ramon y Cajal
Madrid, Madrid, 28034, Spain
Hospital Clinico San Carlos
Madrid, Madrid, 28040, Spain
Hospital Universitario La Paz
Madrid, Madrid, 28046, Spain
Hospital Central de Defensa (del Aire)
Madrid, Madrid, 28047, Spain
Hospital de Navarra
Pamplona, Navarre, 31060, Spain
Hospital Meixoeiro
Vigo, Pontevedra, 36200, Spain
Hospital Virgen Macarena
Seville, Sevilla, 41009, Spain
Hospital Universitario Virgen del Rocio
Seville, Sevilla, 41013, Spain
Hospital Universitario Nuestra Señora De Valme
Seville, Sevilla, 41014, Spain
Hospital Universitario La Fe
Valencia, Valencia, 46009, Spain
Hospital Clinico Universitario
Valencia, Valencia, 46010, Spain
Hospital General Universitario de Valencia
Valencia, Valencia, 46014, Spain
Hospital Universitario
Valladolid, Valladolid, Spain
Hospital de Cruces
Barakaldo, Vizcaya, 48903, Spain
Hospital de Basurto
Bilbao, Vizcaya, 48013, Spain
Hospital Universitari Arnau de Vilanova
Lleida, 25198, Spain
Hospital Marqués de Valdecilla
Santander, 39008, Spain
Hospital Marqués de Valdecilla
Santander, Spain
Hospital Clínico de Valladolid
Valladolid, 47005, Spain
Related Publications (2)
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 Apr-Jun;8(2):136-49. doi: 10.1002/pst.344.
PMID: 18637642BACKGROUNDDavalos A, Alvarez-Sabin J, Castillo J, Diez-Tejedor E, Ferro J, Martinez-Vila E, Serena J, Segura T, Cruz VT, Masjuan J, Cobo E, Secades JJ; International Citicoline Trial on acUte Stroke (ICTUS) trial investigators. Citicoline in the treatment of acute ischaemic stroke: an international, randomised, multicentre, placebo-controlled study (ICTUS trial). Lancet. 2012 Jul 28;380(9839):349-57. doi: 10.1016/S0140-6736(12)60813-7. Epub 2012 Jun 11.
PMID: 22691567RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Antoni Dávalos, MD, PhD
Hospital Universitari Germans Trias i Pujol, Badalona (Spain)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2006
First Posted
May 31, 2006
Study Start
October 1, 2006
Primary Completion
February 1, 2012
Study Completion
March 1, 2012
Last Updated
June 20, 2012
Record last verified: 2012-06