NCT05943821 The Effect of Allopurinol on the Risk of Cardiovascular Events in Patients with Cardiovascular Risk
| NCT ID | NCT05943821 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Poznan University of Medical Sciences |
| Condition | Cardiovascular Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,116 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2028-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,116 participants in total. It began in 2023-09-01 with a primary completion date of 2028-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: 1. Age: between 40-70 years old. 2. Giving informed consent to participate in the study. 3. Serum UA levels above 5 mg/dl within the last six months before the screening visit. 4. Meeting at least one of the criteria defining high or very high CV risk includes: 1. 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 2. documented occurrence of CV diseases (cerebrovascular disease: ischemic stroke, intracerebral bleeding, TIA; heart failure regardless of the etiology NYHA I - II (without IHD), PAD, atrial fibrillation (de novo or ever) 3. diabetes or arterial hypertension complicated by organ damage: * increase in vascular stiffness: pulse pressure ≥ 60 mmHg, and/or cervicofemoral PWV \> 10 m/s; * features of left ventricular hypertrophy on echocardiography or electrocardiography; * increased urine albumin-creatinine ratio (30-300 mg/g); * ankle-brachial index \< 0.9. Exclusion Criteria: 1. Taking allopurinol, febuxostat or other hypouricemic drugs. 2. Contraindications to taking allopurinol. 3. Pregnant women, breastfeeding or planning pregnancy during the duration of the study. 4. Hormonal therapy containing oestrogens. 5. Active cancer process or disease in the last five years, excluding locally malignant tumours. 6. Uncontrolled hypertension (mean value ≥ 180/110 mmHg seven days before screening visit) in home measurements despite using hypotensive drugs. 7. 7\. Renal insufficiency with an eGFR \<45 ml/ min/1.73m2 (according to 2009 CKD-EPI recommendations: stage G3b, G4 and G5). 8. Hypothyroidism or hyperthyroidism not in a state of euthyroidism. 9. Confirmed coronary artery disease (defined as prior AMI, revascularization of the myocardium, confirmed presence of atherosclerotic plaques in coronary arteries on imaging studies). 10. Heart failure in NYHA class III and IV. 11. Taking preparations: azathioprine, mercaptopurine or cyclosporin. Participation in another clinical trial of a medicinal product or medical device within the last three months or five half-lives, whichever period is longer.
Contact & Investigator
Andrzej Tykarski, Prof MD
STUDY DIRECTOR
Poznan University of Medical Sciences
Frequently Asked Questions
Who can join the NCT05943821 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 70 Years, studying Cardiovascular Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05943821 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,116 participants.
Is NCT05943821 currently recruiting?
Yes, NCT05943821 is actively recruiting participants. Contact the research team at puruski@ump.edu.pl for enrollment information.
Where is the NCT05943821 trial being conducted?
This trial is being conducted at Poznan, Poland.
Who is sponsoring the NCT05943821 clinical trial?
NCT05943821 is sponsored by Poznan University of Medical Sciences. The principal investigator is Andrzej Tykarski, Prof MD at Poznan University of Medical Sciences. The trial plans to enroll 1,116 participants.