Efficacy Study of Combined Treatment With Uric Acid and rtPA in Acute Ischemic Stroke (Urico-Ictus)
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ClinicalTrials.gov Identifier: NCT00860366 |
Recruitment Status :
Completed
First Posted : March 12, 2009
Last Update Posted : March 10, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Ischemic Stroke | Drug: Uric Acid Other: Vehicle | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 421 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Randomized, Double Blind Study Assessing the Clinical Efficacy of Combined Treatment With Uric Acid and rtPA Administered Intravenously in Acute Ischemic Stroke Patients Within the First 4.5 Hours of Symptoms Onset |
Study Start Date : | June 2011 |
Actual Primary Completion Date : | August 2013 |
Actual Study Completion Date : | October 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Uric Acid
Single intravenous infusion of 1 gram of Uric Acid dissolved in vehicle (500 ml of 0'1% Lithium Carbonate and 5% Mannitol).
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Drug: Uric Acid
1 gram dissolved in a vehicle containing 500 ml of 0'1% Lithium Carbonate and 5% Mannitol, IV (in the vein), single dose. |
Placebo Comparator: Vehicle
Single intravenous infusion of a 500 ml vehicle containing 0'1% Lithium Carbonate and 5% Mannitol.
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Other: Vehicle
Single intravenous infusion of a 500 ml vehicle containing 0'1% Lithium Carbonate and 5% Mannitol. |
- 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 [ Time Frame: 90 days after the inclusion. ]
- Proportion of patients with NIHSS <2 at 2 hours after completing the experimental treatment. [ Time Frame: 2 hours after completing the experimental treatment ]
- Proportion of patients with NIHSS <1 at day 90. [ Time Frame: Day 90 ]
- Proportion of patients achieving a Barthel scale of 95 to 100 at day 90 [ Time Frame: Day 90 ]
- All-cause mortality within the first 90 days. [ Time Frame: Day 90 ]
- Final Infarction Volume measured by means of MRI or multimodal CT at 72 hours of onset (in specific centers) [ Time Frame: 72 hours ]
- Proportion of patients with an intracranial hemorrhage associated to a worsening of 4 points in the NIHSS within the first 36 hours of treatment. [ Time Frame: 36 hours. ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
- 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.
Exclusion criteria:
- Presence of any of the valid exclusion criteria for the administration of rtPA in the current clinical practise.
- 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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00860366
Spain | |
Hospital Universitari Germans Trias i Pujol | |
Badalona, Barcelona, Spain, 08916 | |
Hospital Universitari de Bellvitge | |
Bellvitge, Barcelona, Spain | |
Corporació Sanitària del Parc Taulí | |
Sabadell, Barcelona, Spain, 08208 | |
Hospital Universitari Mútua de Terrassa | |
Terrassa, Barcelona, Spain, 08221 | |
Hospital de Navarra | |
Pamplona, Navarra, Spain, 31008 | |
Hospital General Universitario de Albacete | |
Albacete, Spain, 02006 | |
Hospital de la Santa Creu y Sant Pau | |
Barcelona, Spain, 08025 | |
Hospital Clínic de Barcelona | |
Barcelona, Spain, 08036 | |
Hospital Dr Josep Trueta | |
Girona, Spain, 17007 | |
Hospital Clínico Universitario de Valladolid | |
Valladolid, Spain, 47005 |
Study Director: | Angel Chamorro, MD, PhD. | Comprehensive Stroke Center, Hospital Clínic Barcelona, Spain. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Angel Chamorro, MD, MD, PhD, Fundacion Clinic per a la Recerca Biomédica |
ClinicalTrials.gov Identifier: | NCT00860366 |
Other Study ID Numbers: |
URICOICTUS-1-2007 EudraCT 2007-002687-95 FIS EC07-90276 |
First Posted: | March 12, 2009 Key Record Dates |
Last Update Posted: | March 10, 2015 |
Last Verified: | March 2015 |
Acute ischemic stroke thrombolysis alteplase |
uric acid neuroprotection oxidative stress |
Stroke Cerebral Infarction Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
Pathologic Processes Brain Infarction Brain Ischemia Uric Acid Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs |