drugset / Trial / NCT00860366
Efficacy Study of Combined Treatment With Uric Acid and rtPA in Acute Ischemic Stroke
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2011-06
- Primary completion
- 2013-08
- Completion
- 2013-10
Publications
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Glucose | Unknown | 1 g | Intravenous |