Randomised, double-blind, placebo-controlled study evaluating the effect of allopurinol on the risk of cardiovascular events in patients with high and very high cardiovascular risk, including the presence of long-COVID-19 syndrome: the ALL-VASCOR study protocol.

Publication date: Jul 24, 2024

Numerous studies, but not all, have suggested a positive effect of allopurinol on the cardiovascular system. The randomised, double-blind, placebo-controlled study evaluating the effect of allopurinol on the risk of cardiovascular events in patients with high and very high cardiovascular risk, including the presence of long-COVID-19 syndrome (ALL-VASCOR) study aims to evaluate the efficacy of allopurinol therapy for improving cardiovascular outcomes in patients at high and very high cardiovascular risk excluding ischaemic heart disease. This is particularly important due to the high cost of cardiovascular disease treatment and its status as one of the leading causes of mortality. The ALL-VASCOR study is a randomised, double-blind, placebo-controlled, multicentre trial that examines the effect of allopurinol therapy (200-500 mg of allopurinol daily) versus an equivalent dose of placebo on the risk of cardiovascular events in 1116 patients aged 40-70 with serum uric acid levels above 5 mg/dL at high and very high risk of cardiovascular disease. The ALL-VASCOR study will also assess the occurrence of long-COVID-19 syndrome. The study will measure primary and secondary as well as additional endpoints and the planned intervention will end on 31 July 2028 unless advised otherwise by the Safe Monitoring Board or other applicable authorities. Participant recruitment is planned to begin in March 2024 in Poland. The study was ethically approved by the Bioethics Committee of Poznan University of Medical Sciences (No 03/23, 12 January 2023). The results are expected after 2028 and will be disseminated in peer-reviewed journals and at international conferences. 01-15 November 2022. EudraCT: 2022-003573-32, 27 October 2022, ClinicalTrials: NCT05943821, 13 July 2023.

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Concepts Keywords
Bioethics Adult
Cardiovascular adult cardiology
Nct05943821 Aged
Poland Allopurinol
Allopurinol
cardiology
Cardiovascular Diseases
clinical trial
COVID-19
Double-Blind Method
Female
Humans
Male
Middle Aged
Post-Acute COVID-19 Syndrome
SARS-CoV-2

Semantics

Type Source Name
drug DRUGBANK Allopurinol
disease MESH COVID-19
disease MESH syndrome
drug DRUGBANK Bepridil
disease VO protocol
disease MESH heart disease
disease MESH cardiovascular disease
disease MESH causes
disease VO dose
drug DRUGBANK Uric Acid
disease IDO intervention
disease MESH long COVID
drug DRUGBANK Xanthine
pathway KEGG Purine metabolism
drug DRUGBANK Ranitidine
disease VO population
drug DRUGBANK Coenzyme M
disease MESH death
drug DRUGBANK Aspartame
disease MESH hypertension
disease MESH stroke
disease MESH myocardial infarction
disease VO time
disease VO adverse event
disease MESH cerebrovascular disease
disease MESH ischaemic stroke
disease MESH bleeding
disease MESH heart failure
disease MESH atrial fibrillation
disease VO organ
disease MESH vascular stiffness
disease MESH left ventricular hypertrophy
drug DRUGBANK Creatinine

Original Article

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