NCT00860366

Brief Summary

The purpose of this study is to determine whether the combined treatment with Uric Acid and rtPA is superior to rtPA alone in terms of clinical efficacy in acute ischemic stroke patients treated within the first 4.5 hours of symptoms onset.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
421

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

10 active sites

Status
completed

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

March 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 12, 2009

Completed
2.2 years until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

March 10, 2015

Status Verified

March 1, 2015

Enrollment Period

2.2 years

First QC Date

March 11, 2009

Last Update Submit

March 9, 2015

Conditions

Acute Ischemic Stroke

Keywords

Acute ischemic strokethrombolysisalteplaseuric acidneuroprotectionoxidative stress

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients achieving a mRS of 0 to 1 at 3 months after treatment, or 2 in those patients with a mRS 2 prior to the inclusion in the study

    90 days after the inclusion.

Secondary Outcomes (6)

  • Proportion of patients with NIHSS <2 at 2 hours after completing the experimental treatment.

    2 hours after completing the experimental treatment

  • Proportion of patients with NIHSS <1 at day 90.

    Day 90

  • Proportion of patients achieving a Barthel scale of 95 to 100 at day 90

    Day 90

  • All-cause mortality within the first 90 days.

    Day 90

  • Final Infarction Volume measured by means of MRI or multimodal CT at 72 hours of onset (in specific centers)

    72 hours

  • +1 more secondary outcomes

Study Arms (2)

Uric Acid

EXPERIMENTAL

Single intravenous infusion of 1 gram of Uric Acid dissolved in vehicle (500 ml of 0'1% Lithium Carbonate and 5% Mannitol).

Drug: Uric Acid

Vehicle

PLACEBO COMPARATOR

Single intravenous infusion of a 500 ml vehicle containing 0'1% Lithium Carbonate and 5% Mannitol.

Other: Vehicle

Interventions

Uric AcidDRUG

1 gram dissolved in a vehicle containing 500 ml of 0'1% Lithium Carbonate and 5% Mannitol, IV (in the vein), single dose.

Uric Acid
VehicleOTHER

Single intravenous infusion of a 500 ml vehicle containing 0'1% Lithium Carbonate and 5% Mannitol.

Vehicle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age older than 18 years old.
  • Acute ischemic stroke treated with rtPA within the first 4.5 hours of clinical onset. Baseline National Institute of Health Stroke Scale (NIHSS) \>6 and \<25, and modified Rankin Scale (mRS) of 2 prior to the stroke.
  • Cranial CT disclosing the absence of blood in the CNS.
  • Informed consent.

You may not qualify if:

  • History of gout with or without history of gouty nephropathy, or uric lithiasis. Asymptomatic hiperuricemia under chronic treatment with allopurinol, or chronic treatment with lithium.
  • Chronic renal insufficiency (baseline creatinine \> 1,5mg/dl).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Hospital General Universitario de Albacete

Albacete, Albacete, 02006, Spain

Location

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital de la Santa Creu y Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

Hospital Clínic de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Hospital Universitari de Bellvitge

Bellvitge, Barcelona, Spain

Location

Corporació Sanitària del Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Hospital Universitari Mútua de Terrassa

Terrassa, Barcelona, 08221, Spain

Location

Hospital Dr Josep Trueta

Girona, Girona, 17007, Spain

Location

Hospital de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital Clínico Universitario de Valladolid

Valladolid, Valladolid, 47005, Spain

Location

Related Publications (13)

  • Chamorro A, Obach V, Cervera A, Revilla M, Deulofeu R, Aponte JH. Prognostic significance of uric acid serum concentration in patients with acute ischemic stroke. Stroke. 2002 Apr;33(4):1048-52. doi: 10.1161/hs0402.105927.

    PMID: 11935059BACKGROUND

  • Chamorro A, Planas AM. Yin and yang of uric acid in patients with stroke. Stroke. 2004 Jan;35(1):e11-2; author reply e11-2. doi: 10.1161/01.STR.0000107762.79571.7D. Epub 2003 Dec 11. No abstract available.

    PMID: 14671231BACKGROUND

  • Chamorro A, Planas AM, Muner DS, Deulofeu R. Uric acid administration for neuroprotection in patients with acute brain ischemia. Med Hypotheses. 2004;62(2):173-6. doi: 10.1016/S0306-9877(03)00324-4.

    PMID: 14962621BACKGROUND

  • Romanos E, Planas AM, Amaro S, Chamorro A. Uric acid reduces brain damage and improves the benefits of rt-PA in a rat model of thromboembolic stroke. J Cereb Blood Flow Metab. 2007 Jan;27(1):14-20. doi: 10.1038/sj.jcbfm.9600312. Epub 2006 Apr 5.

    PMID: 16596120BACKGROUND

  • Amaro S, Soy D, Obach V, Cervera A, Planas AM, Chamorro A. A pilot study of dual treatment with recombinant tissue plasminogen activator and uric acid in acute ischemic stroke. Stroke. 2007 Jul;38(7):2173-5. doi: 10.1161/STROKEAHA.106.480699. Epub 2007 May 24.

    PMID: 17525395BACKGROUND

  • Amaro S, Planas AM, Chamorro A. Uric acid administration in patients with acute stroke: a novel approach to neuroprotection. Expert Rev Neurother. 2008 Feb;8(2):259-70. doi: 10.1586/14737175.8.2.259.

    PMID: 18271711BACKGROUND

  • Amaro S, Chamorro A. Translational stroke research of the combination of thrombolysis and antioxidant therapy. Stroke. 2011 May;42(5):1495-9. doi: 10.1161/STROKEAHA.111.615039. Epub 2011 Apr 7.

    PMID: 21474803BACKGROUND

  • Amaro S, Urra X, Gomez-Choco M, Obach V, Cervera A, Vargas M, Torres F, Rios J, Planas AM, Chamorro A. Uric acid levels are relevant in patients with stroke treated with thrombolysis. Stroke. 2011 Jan;42(1 Suppl):S28-32. doi: 10.1161/STROKEAHA.110.596528. Epub 2010 Dec 16.

    PMID: 21164140BACKGROUND

  • Amaro S, Renu A, Laredo C, Castellanos M, Arenillas JF, Llull L, Rudilloso S, Urra X, Obach V, Chamorro A; on behalf of the URICO-ICTUS investigators. Relevance of Collaterals for the Success of Neuroprotective Therapies in Acute Ischemic Stroke: Insights from the Randomized URICO-ICTUS Trial. Cerebrovasc Dis. 2019;47(3-4):171-177. doi: 10.1159/000500712. Epub 2019 Jun 4.

    PMID: 31163434DERIVED

  • Chamorro A, Amaro S, Castellanos M, Gomis M, Urra X, Blasco J, Arenillas JF, Roman LS, Munoz R, Macho J, Canovas D, Marti-Fabregas J, Leira EC, Planas AM; URICO-ICTUS Investigators. Uric acid therapy improves the outcomes of stroke patients treated with intravenous tissue plasminogen activator and mechanical thrombectomy. Int J Stroke. 2017 Jun;12(4):377-382. doi: 10.1177/1747493016684354. Epub 2016 Dec 20.

    PMID: 28345429DERIVED

  • Amaro S, Laredo C, Renu A, Llull L, Rudilosso S, Obach V, Urra X, Planas AM, Chamorro A; URICO-ICTUS Investigators. Uric Acid Therapy Prevents Early Ischemic Stroke Progression: A Tertiary Analysis of the URICO-ICTUS Trial (Efficacy Study of Combined Treatment With Uric Acid and r-tPA in Acute Ischemic Stroke). Stroke. 2016 Nov;47(11):2874-2876. doi: 10.1161/STROKEAHA.116.014672. Epub 2016 Oct 6.

    PMID: 27758945DERIVED

  • Llull L, Laredo C, Renu A, Perez B, Vila E, Obach V, Urra X, Planas A, Amaro S, Chamorro A. Uric Acid Therapy Improves Clinical Outcome in Women With Acute Ischemic Stroke. Stroke. 2015 Aug;46(8):2162-7. doi: 10.1161/STROKEAHA.115.009960. Epub 2015 Jul 9.

    PMID: 26159792DERIVED

  • Chamorro A, Amaro S, Castellanos M, Segura T, Arenillas J, Marti-Fabregas J, Gallego J, Krupinski J, Gomis M, Canovas D, Carne X, Deulofeu R, Roman LS, Oleaga L, Torres F, Planas AM; URICO-ICTUS Investigators. Safety and efficacy of uric acid in patients with acute stroke (URICO-ICTUS): a randomised, double-blind phase 2b/3 trial. Lancet Neurol. 2014 May;13(5):453-60. doi: 10.1016/S1474-4422(14)70054-7. Epub 2014 Apr 2.

    PMID: 24703208DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Uric Acid

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Angel Chamorro, MD, PhD.

    Comprehensive Stroke Center, Hospital Clínic Barcelona, Spain.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 11, 2009

First Posted

March 12, 2009

Study Start

June 1, 2011

Primary Completion

August 1, 2013

Study Completion

October 1, 2013

Last Updated

March 10, 2015

Record last verified: 2015-03

Locations

ES(10)