Department of Hypertensiology, Angiology and Internal Medicine, Poznan University of Medical Sciences, Poznan, Poland
Department of Hypertensiology, Angiology and Internal Medicine, Poznan University of Medical Sciences, Poznan, Poland.
BMJ Open. 2024 Jul 24;14(7):e075741. doi: 10.1136/bmjopen-2023-075741.
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.
许多研究表明别嘌醇对心血管系统有积极影响，但并非所有研究都如此。这项随机、双盲、安慰剂对照的研究旨在评估别嘌醇治疗在排除缺血性心脏病的高和极高心血管风险患者中的心血管结局改善效果。该研究评估了别嘌醇治疗（每天 200-500 毫克别嘌醇）与等效剂量安慰剂在 1116 名年龄在 40-70 岁、血清尿酸水平高于 5 毫克/分升且患有高和极高心血管疾病风险的患者中的心血管事件风险的影响。ALL-VASCOR 研究还将评估长新冠综合征的发生情况。该研究将测量主要和次要以及额外的终点，计划的干预措施将于 2028 年 7 月 31 日结束，除非安全监测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。
ALL-VASCOR 研究是一项随机、双盲、安慰剂对照、多中心试验，研究了别嘌醇治疗（每天 200-500 毫克别嘌醇）与等效剂量安慰剂在 1116 名年龄在 40-70 岁、血清尿酸水平高于 5 毫克/分升且患有高和极高心血管疾病风险的患者中的心血管事件风险的影响。ALL-VASCOR 研究还将评估长新冠综合征的发生情况。该研究将测量主要和次要以及额外的终点，计划的干预措施将于 2028 年 7 月 31 日结束，除非安全监测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。
该研究已获得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）。预计结果将于 2028 年后公布，并将在同行评议的期刊和国际会议上发表。
2022 年 11 月 1 日至 15 日。
EudraCT：2022-003573-32，2022 年 10 月 27 日；ClinicalTrials：NCT05943821，2023 年 7 月 13 日。
