A Phase 2/3 interventional study of Uric Acid and Vehicle in Acute Ischemic Stroke, sponsored by Angel Chamorro, MD. Completed at 10 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-10.
Sponsored by Angel Chamorro, MD · Phase 2/3, Interventional, and Treatment
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.
Oxidative stress is a major contributor to brain damage in patients with ischemic stroke. Uric acid (UA) is an endogenous product derived from the metabolism of purins which in man is responsable of the 60% of the total antioxidant capacity of the organism. Recent experimental evidences gathered by our and other research groups have shown that the exogenous administration of UA is neuroprotective both in cortical and subcortical brain areas as the result of its antioxidant properties. In these studies, animals treated with UA disclosed smaller brain infarction after transient focal ischemia, both using the intraluminal model or after the injection of autologous clots. Moreover, our group first described greater neuroprotection in animals pretreated with rtPA (alteplase). Likewise, we have recently shown that the administration of UA was free of serious adverse effects in stroke patients receiving rtPA within 3 hours of stroke onset. Yet, preliminary data suggested that this intervention might translate into clinical benefits at 3 months follow-up. Based on these data, we aim to conduct a phase 3, randomized, double-blind, controlled trial assessing the clinical efficacy of UA administration in acute ischemic stroke patients. Currently, rtPA is the only approved therapy for stroke patients within the first hours of clinical onset, and oxidative stress is thought particularly relevant following ischemia/reperfusion. Based on this ground, we aim to conduct this phase 3 clinical trial in ischemic stroke patients which are currently treated with rtPA within the 4'5 hour window.
7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's enrollment of 421 is above the median of 50 across 5,366 interventional studies indexed under Stroke.
Browse Stroke studies →This is the only study on the registry with Angel Chamorro, MD as lead sponsor.
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Exclusion criteria:
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
Single intravenous infusion of a 500 ml vehicle containing 0'1% Lithium Carbonate and 5% Mannitol.
Other: Vehicle
1 gram dissolved in a vehicle containing 500 ml of 0'1% Lithium Carbonate and 5% Mannitol, IV (in the vein), single dose.
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.
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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