Evaluating allopurinol's effect on cardiovascular events in high-risk patients

A Randomized, Double-blind, Placebo-controlled Study Evaluating the Effect of Allopurinol on the Risk of Cardiovascular Events in Patients with High and Very High Cardiovascular Risk, Including the Presence of Long-COVID Syndrome.

This study is testing if the medication allopurinol can help reduce heart problems in people aged 40-70 who have high uric acid levels and are at risk for cardiovascular issues.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 1116 (estimated)
• Ages: 40 Years to 70 Years
• Sex: All
• Sponsor: Poznan University of Medical Sciences (other)
• Locations: 1 site (Poznan, Wielkopolska)
• Trial ID: NCT05943821 on ClinicalTrials.gov

What this trial studies

The ALL-VASCOR study is a randomized, double-blind, placebo-controlled trial that investigates the efficacy of allopurinol therapy in reducing cardiovascular events among patients aged 40-70 with elevated serum uric acid levels and high cardiovascular risk. Participants will receive either allopurinol (200-500mg daily) or a placebo, and the study aims to enroll 1,116 patients across multiple centers in Poland. The trial will also assess the occurrence of long-COVID syndrome and will continue until July 31, 2028, unless otherwise determined by the Safe Monitoring Board.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 40-70 with serum uric acid levels above 5mg/dL and classified as having high or very high cardiovascular risk.

Not a fit: Patients with ischemic heart disease or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved cardiovascular outcomes and reduced healthcare costs for patients at high risk of cardiovascular diseases.

How similar studies have performed: Previous studies have suggested potential benefits of allopurinol on cardiovascular health, but this specific approach is being evaluated in a novel context.

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.

Where this trial is running

Poznan, Wielkopolska

• Poznan University of Medical Sciences — Poznan, Wielkopolska, Poland (RECRUITING)

Study contacts

• Study coordinator: Paweł Uruski, MD PhD

Conditions: Cardiovascular Diseases, Uric Acid