A Phase 3 interventional study of Allopurinol 200 mg and Optional intervention in Cardiovascular Diseases and Uric Acid, sponsored by Poznan University of Medical Sciences. Recruiting at 1 site in Poland. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-01-06.
Sponsored by Poznan University of Medical Sciences · Phase 3, Interventional, and Treatment
Numerous studies, but not all, have suggested a positive effect of allopurinol on the cardiovascular system. The ALL-VASCOR study aims to evaluate the efficacy of allopurinol therapy for improving cardiovascular outcomes in patients at high and very high cardiovascular risk, excluding ischemic heart disease. This is particularly important due to the high cost of cardiovascular disease treatment and its status as one of the leading causes of death.
The ALL-VASCOR study is a randomized, double-blind, placebo-controlled, multi-center trial that examines the effect of allopurinol therapy (200-500mg of allopurinol daily) versus an equivalent dose of placebo on the risk of cardiovascular events in 1,116 patients aged 40-70, with serum uric acid levels above 5mg/dL and with high and very high risk for cardiovascular disease. The ALL-VASCOR study is further designed to assess the occurrence of long-COVID syndrome. The study is directed toward both primary and secondary as well as additional endpoints. Due to the duration of the study, the planned intervention will end on July 31,2028, unless the Safe Monitoring Board or other applicable authorities decide about it. Participant recruitment for the ALL-VASCOR study is set to begin in August of 2023 and will be conducted only within Poland.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's planned enrollment of 1,116 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Poznan University of Medical Sciences is the lead sponsor of 143 studies on the registry; 46 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Meeting at least one of the criteria defining high or very high CV risk includes:
diabetes or arterial hypertension complicated by organ damage:
Exclusion Criteria:
The patients will receive allopurinol at an initial daily dose of 200 mg. If insufficient therapy efficacy is noted, the initial allopurinol dose will be increased by 100 mg (up to 300 mg during V2). Similarly, the dose may be increased by another 100 mg at visit 3 and by another 100 mg at the visit 4 (up to 500 mg during V4).
Drug: Allopurinol 200 mg · Drug: Optional intervention
The patients will receive placebo at an initial daily dose of 200 mg. The dose may be increased by another 100 mg at visit 3 and by another 100 mg at the visit 4 (up to 500 mg during V4).
Drug: Allopurinol 200 mg · Drug: Optional intervention
The intervention will occur after randomly allocating participants to the first group (G1), in which patients will receive allopurinol at an initial daily dose of 200 mg, or to the second group (G2), where they will receive a placebo. The placebo will be prepared as tablets with the same shape and appearance as the tested drug tablets, in the appropriate doses, and containing the same excipients. Participants will initially take one tablet of the medication daily in the morning. The physicians will dispense the drugs in packs of 30 tablets for the entire interval between visits (therapy 26 weeks ± 2 weeks). The patients will receive the medications during visit V1. The drugs will be prepared in identical packages, appropriately sealed, with a number for drug identification.
Also known as: Allopurinol
Approximately 26 weeks(+/-2 weeks) after the start of the intervention, the efficacy of the treatment will be evaluated at the follow-up visit V2. Efficacy is defined as achieving a serum UA level below 5.0mg/dL for those with baseline levels \>5.0 to 7.0mg/dL or below 5.5mg/dL for those with baseline levels ≥7.0mg/dL. If insufficient therapy efficacy is noted, the initial allopurinol dose will be increased by 100mg (up to 300mg during V2). The dose may be increased by another 100mg at visit 3 and by another 100mg at the visit 4(up to 500mg during V4). In the placebo group, an appropriate preparation will be added so that the number of tablets corresponds to the group with the active substance. This treatment will be continued until the end of the bservation. Patients who meet their UA target concentration at visit V2 or V3, or V4, and those who fail to meet their target concentration at visit V4, will not have their dosing changed until the end of the follow-up.
Also known as: Please describe in more detail
The occurrence of a major adverse cardiovascular event (MACE)
The number of all causes of death, cardiac death, stroke, transient ischemic attack, acute coronary syndrome, coronary angioplasty or revascularization, peripheral arterial angioplasty, hospitalization for unstable angina or worsening heart failure
Time frame: Baseline up to approximately 5 years
Percentage of Participants of all-cause death
Events were adjudicated by researchers as all-cause death. The number of all-cause deaths recorded from visit 0 (screening visit) to the last follow-up visit. Depending on the patient and the time of enrollment into the study, this corresponds to visit 7-11.
Time frame: Baseline up to approximately 5 years
Percentage of Participants With Cardiac Death
Description:Events were adjudicated by researchers as cardiac death. The number of all-cause deaths recorded from visit 0 (screening visit) to the last follow-up visit. Depending on the patient and the time of enrollment into the study, this corresponds to visit 7-11.
Time frame: Baseline up to approximately 5 years
Percentage of Participants With stroke
Description:Events were adjudicated by researchers as stroke. The number of all-stroke recorded from visit 0 (screening visit) to the last follow-up visit. Depending on the patient and the time of enrollment into the study, this corresponds to visit 7-11
Time frame: Baseline up to approximately 5 years
Percentage of Participants With transient ischemic attack
Description:Events were adjudicated by researchers as transient ischemic attack. The number of transient ischemic attack recorded from visit 0 (screening visit) to the last follow-up visit. Depending on the patient and the time of enrollment into the study, this corresponds to visit 7-11
Time frame: Baseline up to approximately 5 years
Percentage of Participants With acute coronary syndrome
Description:Events were adjudicated by researchers as acute coronary syndrome,. The number of acute coronary syndrome, recorded from visit 0 (screening visit) to the last follow-up visit. Depending on the patient and the time of enrollment into the study, this corresponds to visit 7-11
Time frame: Baseline up to approximately 5 years
Percentage of Participants With coronary angioplasty or revascularization
Description:Events were adjudicated by researchers as coronary angioplasty or revascularization. The number of coronary angioplasty or revascularization, recorded from visit 0 (screening visit) to the last follow-up visit. Depending on the patient and the time of enrollment into the study, this corresponds to visit 7-11
Time frame: Baseline up to approximately 5 years
Percentage of Participants With peripheral arterial angioplasty
Description:Events were adjudicated by researchers as peripheral arterial angioplasty. The number of peripheral arterial angioplasty recorded from visit 0 (screening visit) to the last follow-up visit. Depending on the patient and the time of enrollment into the study, this corresponds to visit 7-11
Time frame: Baseline up to approximately 5 years
Percentage of Participants With hospitalization for unstable angina or worsening heart failure
Events were adjudicated by researchers as endpoint hospitalization (hospitalization and stay in the emergency department due to heart failure, need for intravenous loop diuretics and/or doubling the dose of oral loop diuretics). The number of hospitalization for unstable angina or worsening heart failure recorded from visit 0 (screening visit) to the last follow-up visit. Depending on the patient and the time of enrollment into the study, this corresponds to visit 7-11
Time frame: Baseline up to approximately 5 years
Percentage of Participants With Hospitalization
Events were adjudicated by researchers as endpoint hospitalization. The number of hospitalization for reasons other than the endpoint number 9, recorded from visit 0 (screening visit) to the last follow-up visit. Depending on the patient and the time of enrollment into the study, this corresponds to visit 7-11
Time frame: Baseline up to approximately 5 years
Assessment of progression and/or development of organ complications and atherosclerosis, including: echocardiography
assessment of echocardiographic parameters - analysis of changes in echocardiographic parameters assessed in transthoracic echocardiographic examination (TTE).Assessment of systolic function (ejection fraction) and left ventricular hypertrophy. Analysis of changes from the baseline
Time frame: Baseline up to the follow-up visit number 7 - approximately 3 years
Assessment of progression and/or development of organ complications and atherosclerosis, including the assessment of incidence of atrial fibrillation
the assessment of the incidence of atrial fibrillation in an electrocardiographic examination (documented incident of de novo atrial fibrillation during observation)
Time frame: Baseline up to the follow-up visit number 7 - approximately 3 years
Assessment of progression and/or development of organ complications and atherosclerosis, including the assessment of end-stage kidney disease
the assessment of end-stage kidney disease based on eGFR measurements. Analysis of changes from the baseline
Time frame: Baseline up to the follow-up visit number 7 - approximately 3 years
Assessment of progression and/or development of organ complications and atherosclerosis, including Ultrasound examination
The assessment of abdominal aorta diameter. Analysis of changes from the baseline
Time frame: Baseline up to the follow-up visit number 7 - approximately 3 years
Assessment of progression and/or development of organ complications and atherosclerosis, including Doppler ultrasound of carotid arteries
Assessment of intima-media complex and atherosclerotic plaques. Analysis of changes from the baseline
Time frame: Baseline up to the follow-up visit number 7 - approximately 3 years
Assessment of progression and/or development of organ complications and atherosclerosis, including the assessment of ankle-brachial index
Assessment of ankle-brachial index. Analysis of changes from the baseline
Time frame: Baseline up to the follow-up visit number 7 - approximately 3 years
Assessment of progression and/or development of organ complications and atherosclerosis, including the assessment of pulse wave velocity
the assessment of pulse wave velocity. Analysis of changes from the baseline
Time frame: Baseline up to the follow-up visit number 7 - approximately 3 years
Occurrence of long-COVID symptoms
Occurrence of long-COVID symptoms assessed based on a survey. Analysis of changes from the baseline. The survey will be recorded from visit 0 (screening visit) to the last follow-up visit. Depending on the patient and the time of enrollment into the study, this corresponds to visit 7-11
Time frame: Baseline up to approximately 5 years
The assessment of treatment efficacy
Attainment of target serum UA levels of 5 mg/dL or 5.5 mg/dL, depending on baseline values
Time frame: Baseline up to the follow-up visit number 7- approximately 3 years
Assessment of the laboratory parameters
Assesment of: Estimated glomerular filtration rate (eGFR). Albumin to creatinine ratio and urinary albuminuria. Glycosylated hemoglobin (HbA1c). Lipid profile. Plasma C-reactive protein concentrations. Activity of aspartate and alanine transaminases (AST, ALT) Analysis all parameters of changes from the baseline
Time frame: Baseline up to the follow-up visit number 7 - approximately 3 years
Assessment of frequency of side effects
Proportion of subjects who experienced at least one serious adverse event (SAE) during the study
Time frame: From the first dose of allopurinol or placebo until the end of the observation period (approximately 3-5 years)
Assessment of changes in participants' cardiovascular risk
Assessment of changes in participants' cardiovascular risk based on the SCORE 2 scale. Analysis of changes from the baseline
Time frame: Baseline up to approximately 5 years
Plan to share: No
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Poznan University of Medical Sciences