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URICO-ICTUS: Uric acid may reduce stroke disability when added to alteplase
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SAN DIEGO — Stroke patients who received uric acid in addition to alteplase may have better recovery compared with those receiving alteplase alone.
The URICO-ICTUS trial was underpowered to definitively conclude that uric acid improved outcomes, but researchers reported a trend toward better recovery from stroke for patients receiving uric acid in addition to alteplase, Angel Chamorro, MD, PhD, said during a press conference at the International Stroke Conference.
Chamorro, of Hospital Clinic Barcelona in Spain, said he and his colleagues are applying for a grant for a 1,500-patient trial that would be adequately powered to determine if uric acid improved outcomes in the stroke population.
Favorable outcomes reported
The double blind, placebo-controlled URICO-ICTUS trial included 411 patients with stroke (mean age, 73 years) who were treated with alteplase within 4.5 hours of ischemic stroke symptom onset at 10 centers in Spain. Of that population, 211 patients received uric acid and 200 received placebo.
The primary endpoint was percentage with favorable outcome at 90 days, defined as a modified Rankin score of 0 or 1, or a modified Rankin score of 2 in patients with a qualifying prior modified Rankin score of 2, Chamorro said at the press conference.
There was a trend toward the uric acid group achieving the primary outcome at a better rate compared with the placebo group (uric acid group, 39.3%; placebo group, 33%; RR=1.23; 95% CI, 0.96-1.56).
“The uric acid group had a 23% relative risk improvement, but the study was not powered to convincingly demonstrate that this was statistically significant,” Chamorro said. “The secondary outcomes were also encouraging.”
One secondary outcome was median modified Rankin score, which was better in the uric acid group (2; interquartile range, 1-4) than in the placebo group (3; interquartile range, 1-4) (P=.045). “This is equivalent to the effect that thrombolytic therapy showed vs. placebo in its first American clinical trial,” he said.
There were no differences between the groups in the safety outcomes of death (RR=0.86; 95% CI, 0.54-1.36), symptomatic intracranial hemorrhage (RR=1.43; 95% CI, 0.52-3.93) or gout attacks (RR=0.24; 95% CI, 0.03-2.08).
Certain subgroups may benefit
The researchers also performed pre-planned exploratory analyses on several subgroups in which the effects of uric acid might differ.
“We know that women may have very low uric acid levels compared to men,” Chamorro said. “We know that uric acid could be specifically relevant in patients where more radicals are produced, and this can occur in patients with more risk for stroke. And we know that glucose in animals is the fuel for oxidative stress.”
Results demonstrated that the uric acid group had better results for the primary outcome than the placebo group in the following subgroups: women (RR=1.46; 95% CI, 1.03-2.07), those with a baseline NIH Stroke Scale score of ≤10 (RR=1.37; 95% CI, 1.01-1.8) and those in the highest tertile of glucose level (RR=1.74; 95% CI, 1.07-2.82). These findings need to be confirmed in a larger trial, Chamorro noted. – by Erik Swain
For more information:
Chamorro A. Plenary Session I: Abstract LB1. Presented at: International Stroke Conference 2014; Feb. 12-14, 2014; San Diego.
Disclosure: The researchers report no relevant financial disclosures.