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New treatment option for Cardiovascular Diseases
Official title The Effect of Allopurinol on the Risk of Cardiovascular Events in Patients with Cardiovascular Risk
ClinicalTrials.gov ID: NCT05943821
What this study is testing
What is Allopurinol 200 mg?
Allopurinol 200 mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for cardiovascular diseases.
Also referred to as Allopurinol.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 70
You may be able to join if
- 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.
- Meeting at least one of the criteria defining high or very high CV risk includes:
- 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
You likely can't join if
- 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.
- Active cancer process or disease in the last five years, excluding locally malignant tumours.
- Uncontrolled hypertension (mean value ≥ 180/110 mmHg seven days before screening visit) in home measurements despite using hypotensive drugs.
See the full eligibility criteria
- 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.
- Meeting at least one of the criteria defining high or very high CV risk includes:
- 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
- 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)
- 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.
- 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.
- Active cancer process or disease in the last five years, excluding locally malignant tumours.
- Uncontrolled hypertension (mean value ≥ 180/110 mmHg seven days before screening visit) in home measurements despite using hypotensive drugs.
- 7\. Renal insufficiency with an eGFR \<45 ml/ min/1.73m2 (according to 2009 CKD-EPI recommendations: stage G3b, G4 and G5).
- Hypothyroidism or hyperthyroidism not in a state of euthyroidism.
- Confirmed coronary artery disease (defined as prior AMI, revascularization of the myocardium, confirmed presence of atherosclerotic plaques in coronary arteries on imaging studies).
- Heart failure in NYHA class III and IV.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Poznan, Wielkopolska, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Poznan, Wielkopolska, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.