Allopurinol for Hyperuricemia | Hypertension | Ischaemic stroke | Intracerebral haemorrhage | Transient ischaemic attack | Heart failure | Peripheral arterial disease | Atrial fibrillation | Diabetes mellitus

Inclusion criteria

• {"criterion_text":"- Age: between 40 and 70 years old"}
• {"criterion_text":"- Giving informed consent to participate in the study"}
• {"criterion_text":"- Serum uric acid above 5mg/dl within the last 6 months for screening"}
• {"criterion_text":"- 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."}

Exclusion criteria

• {"criterion_text":"- Taking allopurinol, febuxostat or other hypouricemic drugs within the last 6 months for screening."}
• {"criterion_text":"- Active neoplastic process or neoplastic disease in the last 5 years, excluding locally malignant neoplasms."}
• {"criterion_text":"- Uncontrolled hypertension (mean value ≥ 180/110 mmHg on the 7th day preceding the screening visit) in home measurements despite the use of antihypertensive drugs."}
• {"criterion_text":"- Renal failure with renal filtration rate eGFR <30 ml/min/ 1.73 m2 (according to recommendations of 2009 CKD-EPI G3b, G4 and G5)."}
• {"criterion_text":"- Hypothyroidism or hyperthyroidism not in a euthyroid state."}
• {"criterion_text":"- 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)."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Heart failure in class III and IV according to NYHA"}
• {"criterion_text":"- Taking preparations: azathioprine, mercaptopurine, cyclosporine."}
• {"criterion_text":"- Participation in another clinical trial on a medicinal product or medical device within the last 3 months or 5 half-lives, whichever is longer"}
• {"criterion_text":"- Diagnosed liver cirrhosis regardless of etiology."}
• {"criterion_text":"- Aspartate and/or alanine transaminase activity exceeding 3 times the upper limit of normal during the screening period"}
• {"criterion_text":"- Contraindications to taking allopurinol preparation"}
• {"criterion_text":"- Women who are pregnant, lactating or planning to become pregnant during the study."}
• {"criterion_text":"- Hormone therapy containing estrogens."}

Primary endpoints

• {"endpoint_text":"- Occurrence of a major cardiovascular event (MACE) such as all cause death, cardiac death, stroke/TIA, acute coronary syndrome, coronary artery angioplasty or revascularization, peripheral arterial angioplasty, hospitalization for unstable angina, or worsening heart failure (hospitalization and stay in the emergency room / Hospital Emergency Department due to heart failure, the need for intravenous loop diuretic and/or doubling the dose of oral loop diuretic).","definition_or_measurement_approach":"Composite MACE defined as occurrence of any of: all-cause death, cardiac death, stroke/TIA, acute coronary syndrome, coronary artery angioplasty or revascularization, peripheral arterial angioplasty, hospitalization for unstable angina, or worsening heart failure (hospitalization/ER visit for heart failure, need for intravenous loop diuretic and/or doubling of oral loop diuretic)."}

Secondary endpoints

• {"endpoint_text":"- Individual MACE components alone or in combination","definition_or_measurement_approach":"Occurrence of individual components of the primary composite endpoint assessed separately or in combinations."}
• {"endpoint_text":"- Hospitalisation for reasons other than the primary endpoint.","definition_or_measurement_approach":"All-cause hospitalisations excluding those counted in the primary endpoint."}
• {"endpoint_text":"- The assessment of the progression and/or development of organ complications and the development and/or progression of atherosclerosis including: echocardiography; the assessment of the incidence of atrial fibrillation in an electrocardiographic examination ; assessment of abdominal aorta diameter in uultrasound examination; the assessment of the intima-media complex and atherosclerotic plaques in the Doppler ultrasound of the carotid arteries; the assessment of the ankle-brachial index;","definition_or_measurement_approach":"Assessment of organ complications and atherosclerosis progression via echocardiography, ECG for atrial fibrillation, abdominal aorta ultrasound diameter, carotid Doppler intima-media and plaque assessment, and ankle-brachial index."}
• {"endpoint_text":"- The occurrence of long-COVID-19 symptoms.","definition_or_measurement_approach":"Recording/assessment of presence of long-COVID symptoms."}
• {"endpoint_text":"- The assessment of treatment efficacy: the attainment of target serum uric acid levels of 5 mg/dL or 5.5 mg/dL depending on baseline values.","definition_or_measurement_approach":"Laboratory measurement of serum uric acid and assessment whether target levels (5.0 or 5.5 mg/dL depending on baseline) are achieved."}
• {"endpoint_text":"- The assessment of other laboratory parameters: estimated glomerular filtration rate (eGFR), albumin-to-creatinine ratio, urinary albuminuria; HbA1c; lipid profile; plasma C reactive protein concentrations; activity of aspartate and alanine transaminases (AspAT, AlAT).","definition_or_measurement_approach":"Laboratory testing of eGFR, albumin-to-creatinine ratio, urinary albumin, HbA1c, lipid profile, CRP, AST/ALT."}
• {"endpoint_text":"- The assessment of the frequency of side effects.","definition_or_measurement_approach":"Recording and frequency analysis of adverse events."}
• {"endpoint_text":"- The assessment of changes in participants’ CVs based on the Systematic Coronary Risk Evaluation (SCORE) 2 scale","definition_or_measurement_approach":"Assessment of cardiovascular risk change using SCORE2 scale."}

Poland

Earliest CTIS Part Ii Submission Date

05-11-2024

Latest Decision Or Authorization Date

03-12-2025

Processing Time Days

393

Number Of Sites

18

Number Of Participants

1116

Primary sponsor

Full Name

Uniwersytet Medyczny Im. Karola Marcinkowskiego W Poznaniu

Organisation Type

Educational Institution

Country Of Registered Address

Poland

Contract research organisations

Name

Cefea Sp. z o.o. sp.k.

Responsibilities

Packaging, labeling, and delivery of the IMP, IMP release

Name

Scientia CRO Sp. z o.o.

Responsibilities

Sponsor duties codes: 1,10,11,12,7,8 (as listed in record)

Third parties

• {"country":"Poland","full_name":"Cefea Sp. z o.o. sp.k.","duties_or_roles":"Packaging, labeling, and delivery of the IMP, IMP release","organisation_type":"Pharmaceutical company"}
• {"country":"Poland","full_name":"Scientia CRO Sp. z o.o.","duties_or_roles":"Codes: 1,10,11,12,7,8","organisation_type":"Pharmaceutical company"}