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Recruiting Phase 3 NCT05943821

The Effect of Allopurinol on the Risk of Cardiovascular Events in Patients with Cardiovascular Risk

Trial Parameters

Condition Cardiovascular Diseases
Sponsor Poznan University of Medical Sciences
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 1,116
Sex ALL
Min Age 40 Years
Max Age 70 Years
Start Date 2023-09-01
Completion 2028-07-31
Interventions
Allopurinol 200 mgOptional intervention

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: 1. Age: between 40-70 years old. 2. Giving informed consent to participate in the study. 3. Serum UA levels above 5 mg/dl within the last six months before the screening visit. 4. Meeting at least one of the criteria defining high or very high CV risk includes: 1. 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 2. 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) 3. 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. Exclusi

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