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

Launched by POZNAN UNIVERSITY OF MEDICAL SCIENCES · Jul 5, 2023

Keywords

ClinConnect Summary

The ALL-VASCOR study is a clinical trial that is looking at whether a medication called allopurinol can help reduce the risk of heart-related problems in people who are already at high risk for cardiovascular diseases. This is important because heart disease is a leading cause of death, and finding effective treatments can help improve patients' lives. To participate in this study, individuals need to be between 40 and 70 years old, have higher levels of uric acid in their blood, and meet specific criteria that indicate they are at high or very high risk for cardiovascular issues, such as having diabetes or high blood pressure with complications.

Participants in this trial will take allopurinol and will be monitored for changes in their heart health over time. However, some individuals may not be eligible if they are currently taking certain medications, have specific medical conditions, or are pregnant or breastfeeding. The study is currently recruiting participants, and it aims to provide valuable information about how allopurinol might help improve heart health for those at risk.

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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.
• Exclusion Criteria:
• • 1. Taking allopurinol, febuxostat or other hypouricemic drugs.
• • 2. Contraindications to taking allopurinol.
• • 3. Pregnant women, breastfeeding or planning pregnancy during the duration of the study.
• • 4. Hormonal therapy containing oestrogens.
• • 5. Active cancer process or disease in the last five years, excluding locally malignant tumours.
• • 6. Uncontrolled hypertension (mean value ≥ 180/110 mmHg seven days before screening visit) in home measurements despite using hypotensive drugs.
• • 7. 7. Renal insufficiency with an eGFR \<45 ml/ min/1.73m2 (according to 2009 CKD-EPI recommendations: stage G3b, G4 and G5).
• • 8. Hypothyroidism or hyperthyroidism not in a state of euthyroidism.
• • 9. Confirmed coronary artery disease (defined as prior AMI, revascularization of the myocardium, confirmed presence of atherosclerotic plaques in coronary arteries on imaging studies).
• • 10. Heart failure in NYHA class III and IV.
• • 11. 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.