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

Prior treatment

• 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).

Other illness

• Active cancer process or disease in the last five years, excluding locally malignant tumours.
• Heart failure in NYHA class III and IV.

Lab values

• 7\. Renal insufficiency with an eGFR \<45 ml/ min/1.73m2 (according to 2009 CKD-EPI recommendations: stage G3b, G4 and G5).

Other

• 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.

• 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.