The Influence of Febuxostat on Coronary Artery Endothelial Dysfunction in Participants With Chronic Stable Angina

Phase 4 Completed 30 enrolled Takeda

RandomizedCrossoverDouble-blindTreatment

Summary

The purpose of this study is to assess the effect of febuxostat on coronary artery flow in patients with coronary artery disease.

Timeline

Start: 2013-05
Primary completion: 2015-03
Completion: 2015-04

Outcome

Missed primary endpoint

registry Placebo vs Febuxostat 80 mg; p = 0.756; LS Mean Difference 1.8 (95% CI -10.10 to 13.76); ANOVA; note: 0.05 level of significance NCT01763996 ↗

paper it did not improve the primary end point of the study, CEF measured using MRI after 6 weeks of treatment. PMID 29447788 ↗

Publications

Hays AG, Iantorno M, Schar M, Lai S, Czarny M, Breton E, Palmer RN, Whelton A, Weiss RG, Gerstenblith G. The influence of febuxostat on coronary artery endothelial dysfunction in patients with coronary artery disease: A phase 4 randomized, placebo-controlled, double-blind, crossover trial. Am Heart J. 2018 Mar;197:85-93. doi: 10.1016/j.ahj.2017.11.006. Epub 2017 Nov 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Febuxostat	Small molecule	80 mg	Oral