Aspirin for Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease
Trial Parameters
Brief Summary
Metabolic dysfunction-associated steatotic liver disease (MASLD) is a leading cause of chronic liver disease worldwide and a significant public health issue. MASLD may progress to liver cirrhosis and/or hepatocellular carcinoma. Although previous evidence suggests that aspirin has antisteatotic and antifibrotic effects on the liver, a randomized controlled trial assessing long-term efficacy and safety of aspirin in MASLD patients has yet to be conducted. This study aims to conduct a randomized controlled trial to evaluate the efficacy of aspirin in treating MASLD.
Eligibility Criteria
Inclusion Criteria: 1. 18 years of age or older 2. Diagnosed with MASLD, which is defined by the Delphi consensus, with at least one out of five cardiometabolic criteria Exclusion Criteria: 1. Increased alcohol intake (average ≥ 20 g/day for women and ≥ 30 g/day for men) 2. Glycated hemoglobin (HbA1c) level ≥ 9.0% 3. Other causes of chronic liver disease, such as HBV, HCV, autoimmune hepatitis, Wilson's disease, etc. 4. Liver decompensation (Child-Pugh class B or C) 5. Liver cirrhosis with significant portal hypertension (platelet count \< 100,000/mm3, splenomegaly, and/or the presence of esophageal/gastric varices) 6. High-risk EGV, defined as F2, F3, or with red-color signs, diagnosed by endoscopy within 6 months before screening 7. Active peptic ulcer disease diagnosed by endoscopy within 6 months be- fore screening 8. FIB-4 index \< 1.3 at screening 9. Indicated for any anti-platelet therapy, such as history of cardiovascular events 10. History of aspirin allergy 11. History of ble