Skip to content

A Randomized, Double-blind, Placebo-controlled Study Evaluating the Effect of Allopurinol on the Risk of Cardiovascular Events in Patients With High and Very High Cardiovascular Risk, Including the Presence of Long-COVID Syndrome.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517610-15-00
Acronym
2022/ABM/01/00027
Enrollment
1116
Registered
2024-12-16
Start date
2024-03-28
Completion date
Unknown
Last updated
2025-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hyperuricemia, hypertension, ischemic stroke, intracerebral haemorrhage, TIA, heart failure, peripheral arterial disease, atrial fibrillation, diabetes mellitus

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

DRUGMilurit
DRUG200 mg
DRUGtabletki
DRUGMicrocrystalline cellulose Magnesium stearate

Sponsors

Uniwersytet Medyczny Im. Karola Marcinkowskiego W Poznaniu
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026