hyperuricemia, hypertension, ischemic stroke, intracerebral haemorrhage, TIA, heart failure, peripheral arterial disease, atrial fibrillation, diabetes mellitus
Conditions
Brief summary
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).
Detailed description
Individual MACE components alone or in combination, Hospitalisation for reasons other than the primary endpoint., 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;, The occurrence of long-COVID-19 symptoms., 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., 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)., The assessment of the frequency of side effects., The assessment of changes in participants’ CVs based on the Systematic Coronary Risk Evaluation (SCORE) 2 scale
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| Individual MACE components alone or in combination, Hospitalisation for reasons other than the primary endpoint., 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;, The occurrence of long-COVID-19 symptoms., 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., 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; ac | — |
Countries
Poland