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

Katarzyna Lewandowska; Dawid Lipski; Paweł Uruski; Krzysztof Narkiewicz; Andrzej Januszewicz; Jacek Wolf; Aleksander Prejbisz; Marek Rajzer; Andrzej Więcek; Andrzej Tykarski

doi:10.1136/bmjopen-2023-075741

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

BMJ Open. 2024 Jul 24;14(7):e075741. doi: 10.1136/bmjopen-2023-075741.

Affiliations

¹ Department of Hypertensiology, Angiology and Internal Medicine, Poznan University of Medical Sciences, Poznan, Poland katarzyna.lewandowska@usk.poznan.pl.
² Department of Hypertensiology, Angiology and Internal Medicine, Poznan University of Medical Sciences, Poznan, Poland.
³ Department of Hypertension and Diabetology, Medical University of Gdansk, Gdansk, Poland.
⁴ Department of Hypertension, National Institute of Cardiology, Warsaw, Poland.
⁵ Department of Epidemiology, Cardiovascular Prevention and Health Promotion, National Institute of Cardiology, Warsaw, Poland.
⁶ First Department of Cardiology, Interventional Electrocardiology and Arterial Hypertension, Jagiellonian University Medical College, Krakow, Poland.
⁷ Department of Nephrology, Transplantation and Internal Medicine, Medical University of Silesia, Katowice, Poland.

Abstract

Introduction: 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.

Methods and analysis: 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.

Ethics and dissemination: 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.

Protocol version number: 01-15 November 2022.

Trial registration number: EudraCT: 2022-003573-32, 27 October 2022, ClinicalTrials: NCT05943821, 13 July 2023.

Keywords: adult cardiology; cardiology; clinical trial.

Publication types

Clinical Trial Protocol
Randomized Controlled Trial
Multicenter Study

MeSH terms

Adult
Aged
Allopurinol* / therapeutic use
COVID-19* / complications
Cardiovascular Diseases* / prevention & control
Double-Blind Method
Female
Heart Disease Risk Factors
Humans
Male
Middle Aged
Post-Acute COVID-19 Syndrome
Randomized Controlled Trials as Topic
SARS-CoV-2

Substances

Allopurinol

Associated data

ClinicalTrials.gov/NCT05943821