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Allopurinol as a preventive drug in patients with high and very high cardiovascular risk, taking into account the presence of the long-COVID syndrome.
EU CTIS ID: 2024-517610-15-00
What this study is testing
In patients with very high and high cardiovascular risk, the use of allopurinol will reduce cardiovascular risk, in the entire study population and in the group over 60 years of age.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age: between 40 and 70 years old
- Giving informed consent to participate in the study
- Serum uric acid above 5mg/dl within the last 6 months for screening
- At least one of the criteria for very high or high cardiovascular risk: a. calculated 10-year risk of death from cardiovascular causes according to SCORE2 >2.5% for patients <50 years of age or ≥5% for patients ≥50 years of age b. documented occurrence of cardiovascular diseases (cerebrovascular disease: ischemic stroke, intracerebral bleeding, TIA; heart failure regardless of the etiology NYHA I - II, peripheral arterial disease PAD, atrial fibrillation (de novo or ever in history) c. diabetes or hypertension complicated by organ damage: i. increase in vascular stiffness: pulse pressure ≥ 60 mmHg, and/or cervicofemoral pulse wave velocity > 10 m/s ii. features of left ventricular hypertrophy on echocardiography or electrocardiography iii. elevated albumin-creatinine ratio in the urine sample (30-300 mg/g) iv. ankle-brachial index < 0.9.
You likely can't join if
- Taking allopurinol, febuxostat or other hypouricemic drugs within the last 6 months for screening.
- Active neoplastic process or neoplastic disease in the last 5 years, excluding locally malignant neoplasms.
- Uncontrolled hypertension (mean value ≥ 180/110 mmHg on the 7th day preceding the screening visit) in home measurements despite the use of antihypertensive drugs.
- Renal failure with renal filtration rate eGFR <30 ml/min/ 1.73 m2 (according to recommendations of 2009 CKD-EPI G3b, G4 and G5).
- Hypothyroidism or hyperthyroidism not in a euthyroid state.
- Confirmed ischemic heart disease (defined as: history of AMI, myocardial revascularization or or the occurrence of angina symptoms accompanied by atherosclerotic changes in coronary vessels > 50% detected in computed tomography or coronary angiography).
See the full eligibility criteria
Who can join
- Age: between 40 and 70 years old
- Giving informed consent to participate in the study
- Serum uric acid above 5mg/dl within the last 6 months for screening
- At least one of the criteria for very high or high cardiovascular risk: a. calculated 10-year risk of death from cardiovascular causes according to SCORE2 >2.5% for patients <50 years of age or ≥5% for patients ≥50 years of age b. documented occurrence of cardiovascular diseases (cerebrovascular disease: ischemic stroke, intracerebral bleeding, TIA; heart failure regardless of the etiology NYHA I - II, peripheral arterial disease PAD, atrial fibrillation (de novo or ever in history) c. diabetes or hypertension complicated by organ damage: i. increase in vascular stiffness: pulse pressure ≥ 60 mmHg, and/or cervicofemoral pulse wave velocity > 10 m/s ii. features of left ventricular hypertrophy on echocardiography or electrocardiography iii. elevated albumin-creatinine ratio in the urine sample (30-300 mg/g) iv. ankle-brachial index < 0.9.
What rules you out
- Taking allopurinol, febuxostat or other hypouricemic drugs within the last 6 months for screening.
- Active neoplastic process or neoplastic disease in the last 5 years, excluding locally malignant neoplasms.
- Uncontrolled hypertension (mean value ≥ 180/110 mmHg on the 7th day preceding the screening visit) in home measurements despite the use of antihypertensive drugs.
- Renal failure with renal filtration rate eGFR <30 ml/min/ 1.73 m2 (according to recommendations of 2009 CKD-EPI G3b, G4 and G5).
- Hypothyroidism or hyperthyroidism not in a euthyroid state.
- Confirmed ischemic heart disease (defined as: history of AMI, myocardial revascularization or or the occurrence of angina symptoms accompanied by atherosclerotic changes in coronary vessels > 50% detected in computed tomography or coronary angiography).
- Any condition or circumstance that, in the investigator’s judgment, could interfere with conduct of the study per protocol or with obtaining written informed consent, e.g., alcohol, drug, or other substance abuse or dependence.
- Heart failure in class III and IV according to NYHA
- Taking preparations: azathioprine, mercaptopurine, cyclosporine.
- Participation in another clinical trial on a medicinal product or medical device within the last 3 months or 5 half-lives, whichever is longer
- Diagnosed liver cirrhosis regardless of etiology.
- Aspartate and/or alanine transaminase activity exceeding 3 times the upper limit of normal during the screening period
- Contraindications to taking allopurinol preparation
- Women who are pregnant, lactating or planning to become pregnant during the study.
- Hormone therapy containing estrogens.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.