Allopurinol as a preventive drug in patients with high and very high cardiovascular risk, taking into account the presence of the long-COVID syndrome.

A randomized, double-blind, placebo-controlled study to evaluate the effect of allopurinol on the risk of cardiovascular events in patients at high and very high cardiovascular risk, including the presence of long-COVID syndrome. - ALL-VASCOR

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-003573-32-PL

Enrollment

1116

Registered

2022-12-20

Start date

2023-12-28

Completion date

Unknown

Last updated

2025-01-07

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 MedDRA version: 20.1 Level: LLT Classification code 10020907 Term: Hyperuricemia System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 20.0 Level: PT Classification code 10020772 Term: Hypertension System Organ Class: 10047065 - Vascular disorders MedDRA version: 22.1 Level: PT Classification code 10061256

Interventions

Trade Name: Milurit (Allopurinolum) 200mg Product Name: Milurit (Allopurinolum) Pharmaceutical Form: Tablet INN or Proposed INN: Allopurinol CAS Number: 315-30-0 Concentration unit: mg milligram(s) Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Age: between 40 and 70 years old 2. Giving informed consent to participate in the study 3. Serum uric acid above 5mg/dl within the last 6 months for screening 4. 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 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 =65 years) yes F.1.3.1 Number of subjects for this age range 345

Exclusion criteria

Exclusion criteria: 1. Taking allopurinol, febuxostat or other hypouricemic drugs within the last 6 months for screening. 2. Contraindications to taking allopurinol preparation. 3. Women who are pregnant, lactating or planning to become pregnant during the study. 4. Hormone therapy containing estrogens. 5. Active neoplastic process or neoplastic disease in the last 5 years, excluding locally malignant neoplasms. 6. Uncontrolled hypertension (mean value = 180/110 mmHg on the 7th day preceding the screening visit) in home measurements despite the use of antihypertensive drugs. 7. Renal failure with renal filtration rate eGFR 50% detected in computed tomography or coronary angiography). 10. Heart failure in class III and IV according to NYHA. 11. Taking preparations: azathioprine, mercaptopurine, cyclosporine. 12. Participation in another clinical trial on a medicinal product or medical device within the last 3 months or 5 half-lives, whichever is longer 13.Diagnosed liver cirrhosis regardless of etiology. 14.Aspartate and/or alanine transaminase activity exceeding 3 times the upper limit of normal during the screening period.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: 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).;Primary end point(s): 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).;Timepoint(s) of evaluation of this end point: end of the trial	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: 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).;Primary end point(s): 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).;Timepoint(s) of evaluation of this end point: end of the trial

—

Secondary

Measure	Time frame
Secondary end point(s): end of the trial;Timepoint(s) of evaluation of this end point: end of the trial	—

Countries

Poland

Contacts

Public ContactMD Pawel Uruski

MD Pawel Uruski

puruski@ump.edu.pl+48618549090

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 6, 2026