Tests whether allopurinol affects heart and blood vessel events in higher-risk adults
Tests allopurinol against a placebo in adults at high cardiovascular risk.
Plain-language title generated from the registry record
Registry title: The Effect of Allopurinol on the Risk of Cardiovascular Events in Patients with Cardiovascular Risk
Key facts
- Where
- Cracow, Gdansk, Jaksice, Katowice, Kielce, Lodz, Poznan, Słupsk, Warsaw, and Wroclaw, PolandSee the 14 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 70 years old?
Source: NCT05943821, who can take part
Where in Poland
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W KrakowieCracow, PolandNo longer taking part
- Uniwersyteckie Centrum KliniczneGdansk, PolandNo longer taking part
- Medsearch InstituteJaksice, PolandNo longer taking part
- Clinical Medical Research Sp. z o.o.Katowice, PolandNo longer taking part
- Samodzielny Publiczny Szpital Kliniczny Im.Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego W KatowicachKatowice, PolandNo longer taking part
- Santa Sp. z o.o. sp.k.Kielce, PolandNo longer taking part
- Salve Medica Sp. z o.o. S.K.Lodz, PolandNo longer taking part
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W LodziLodz, PolandNo longer taking part
- Santa SP. z o.oLodz, PolandNo longer taking part
- Uniwersytecki Szpital Kliniczny w PoznaniuPoznan, PolandNo longer taking part
- Indywidualna Specjalistyczna Praktyka Lekarska dr n. med. Paweł LewandowskiSłupsk, PolandNo longer taking part
- Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut BadawczyWarsaw, PolandNo longer taking part
- Polimedica Centrum Badan Profilaktyki I Leczenia Sp. z o.o.Warsaw, PolandNo longer taking part
- 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We WroclawiuWroclaw, PolandNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Poznan University of Medical Sciences
- Trial code
- NCT05943821EU 2024-517610-15-00
- Record updated
- 6 January 2025
- Original description
Numerous studies, but not all, have suggested a positive effect of allopurinol on the cardiovascular system. The 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 ischemic 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 death.Read full original descriptionShow less
A Randomized, 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 Syndrome.
Numerous studies, but not all, have suggested a positive effect of allopurinol on the cardiovascular system. The 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 ischemic 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 death.
Inclusion: Age: between 40-70 years old; Giving informed consent to participate in the study; Serum UA levels above 5 mg/dl within the last six months before the screening visit; Meeting at least one of the criteria defining high or very high CV risk includes:; calculated 10-year cardiovascular mortality risk based on SCORE2 >2.5% for patients under 50 years old or ≥5% for patients 50 years old or older; documented occurrence of CV diseases (cerebrovascular disease: ischemic stroke, intracerebral bleeding, TIA; heart failure regardless of the etiology NYHA I - II (without IHD), PAD, atrial fibrillation (de novo or ever); diabetes or arterial hypertension complicated by organ damage:; increase in vascular stiffness: pulse pressure ≥ 60 mmHg, and/or cervicofemoral PWV > 10 m/s; features of left ventricular hypertrophy on echocardiography or electrocardiography; increased urine albumin-creatinine ratio (30-300 mg/g); ankle-brachial index < 0.9.
Exclusion: Taking allopurinol, febuxostat or other hypouricemic drugs; Hormonal therapy containing oestrogens; Uncontrolled hypertension (mean value ≥ 180/110 mmHg seven days before screening visit) in home measurements despite using hypotensive drugs; Confirmed coronary artery disease (defined as prior AMI, revascularization of the myocardium, confirmed presence of atherosclerotic plaques in coronary arteries on imaging studies); Active cancer process or disease in the last five years, excluding locally malignant tumours; Heart failure in NYHA class III and IV; 7. Renal insufficiency with an eGFR <45 ml/ min/1.73m2 (according to 2009 CKD-EPI recommendations: stage G3b, G4 and G5); Contraindications to taking allopurinol; Pregnant women, breastfeeding or planning pregnancy during the duration of the study; Hypothyroidism or hyperthyroidism not in a state of euthyroidism; Taking preparations: azathioprine, mercaptopurine or cyclosporin. Participation in another clinical trial of a medicinal product or medical device within the last three months or five half-lives, whichever period is longer.