背景:大量研究,但不是全部,表明别嘌呤醇对心血管系统有积极作用。随机的,双盲,安慰剂对照研究评估别嘌呤醇对高和极高心血管风险患者心血管事件风险的影响,包括存在长COVID-19综合征(ALL-VASCOR)在内的研究旨在评估别嘌醇治疗改善心血管疾病高危和极高危患者心血管结局的疗效,排除缺血性心脏病.由于心血管疾病治疗的高成本及其作为死亡的主要原因之一的地位,这一点尤为重要。
方法:ALL-VASCOR研究是一项随机研究,双盲,安慰剂对照,多中心试验研究了在心血管疾病高风险和非常高的情况下,在40-70岁的血清尿酸水平高于5mg/dL的1116例患者中,别嘌醇治疗(每天200-500mg别嘌醇)与等效剂量安慰剂对心血管事件风险的影响。ALL-VASCOR研究还将评估长COVID-19综合征的发生。该研究将测量主要和次要以及其他终点,计划的干预措施将于2028年7月31日结束,除非安全监控委员会或其他适用机构另有建议。参与者招募计划于2024年3月在波兰开始。
背景:该研究得到了波兹南医科大学生物伦理委员会的伦理批准(2023年1月12日,第03/23号)。预计结果将在2028年之后发布,并将在同行评审的期刊和国际会议上传播。
■2022年11月1日至15日。
背景:EudraCT:2022-003573-32,2022年10月27日,临床试验:NCT05943821,2023年7月13日。
BACKGROUND: 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: 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.
BACKGROUND: 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.
UNASSIGNED: 01-15 November 2022.
BACKGROUND: EudraCT: 2022-003573-32, 27 October 2022, ClinicalTrials: NCT05943821, 13 July 2023.