Study of Allopurinol Versus Placebo to Lower Cardiovascular Event Risk in Patients with High Cardiovascular Risk Including Long-COVID A Randomized, Double-Blind, Placebo-Controlled Trial

What this Trial Is About

Researchers are evaluating the effect of allopurinol therapy on cardiovascular outcomes in patients aged 40 to 70 who have high or very high cardiovascular risk and elevated serum uric acid levels. The study excludes those with ischemic heart disease and also aims to assess the occurrence of long-COVID syndrome. This randomized, double-blind, placebo-controlled, multi-center phase 3 trial will enroll 1,116 participants in Poland to better understand allopurinol's impact on cardiovascular event risk. Participants will be randomly assigned to receive either allopurinol starting at 200 mg daily or a matching placebo. The dose may be increased every 26 weeks based on serum uric acid levels, up to a maximum of 500 mg daily for allopurinol or a corresponding placebo dosage. Treatment will continue until July 31, 2028, unless stopped earlier by monitoring authorities. Medication will be dispensed in 30-tablet packs for 26-week intervals, and participants will be closely monitored throughout the study period. During the study, researchers will track the occurrence of major adverse cardiovascular events over approximately 5 years. Participants will undergo regular visits for efficacy evaluation, blood tests to measure uric acid levels, and safety monitoring. The study will also collect data on long-COVID syndrome and other cardiovascular health markers. Overall participation may last up to nearly five years, with ongoing follow-up to assess the long-term effects of the treatment.

The Effect of Allopurinol on the Risk of Cardiovascular Events in Patients with Cardiovascular Risk