The Effect of Allopurinol on the Risk of Cardiovascular Events in Patients with Cardiovascular Risk
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40-70
SponsorPoznan University of Medical Sciences
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: between 40-70 years old.
Giving informed consent to participate in the study.
Serum UA levels above 5 mg/dl within the last six months before the screening visit.
calculated 10-year cardiovascular mortality risk based on SCORE2 >2.5% for patients under 50 years old or ≥5% for patients 50 years old or older
Disqualifiers
Taking allopurinol, febuxostat or other hypouricemic drugs.
Contraindications to taking allopurinol.
Pregnant women, breastfeeding or planning pregnancy during the duration of the study.
Hormonal therapy containing oestrogens.
Trial design
Design model
Parallel
Treatments tested in this trial
Allopurinol 200 mg
DrugThe 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.
Optional intervention
DrugApproximately 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.
Treatment groups
1,116 Participants
are divided into 2 treatment groupsGroup A: AllopurinolActive comparator 2 interventions
Group B: PlaceboPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
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 yearsSecondary outcomes
1
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 years2
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 years3
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 years4
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 yearsOther outcomes
1
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 years2
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 years3
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 years4
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 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov