Aspirin for Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease
Aspirin for Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease: A Randomized Controlled Trial
Taichung Veterans General Hospital
120 participants
May 5, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria2
- 18 years of age or older
- Diagnosed with MASLD, which is defined by the Delphi consensus, with at least one out of five cardiometabolic criteria
Exclusion Criteria14
- Increased alcohol intake (average ≥ 20 g/day for women and ≥ 30 g/day for men)
- Glycated hemoglobin (HbA1c) level ≥ 9.0%
- Other causes of chronic liver disease, such as HBV, HCV, autoimmune hepatitis, Wilson's disease, etc.
- Liver decompensation (Child-Pugh class B or C)
- Liver cirrhosis with significant portal hypertension (platelet count < 100,000/mm3, splenomegaly, and/or the presence of esophageal/gastric varices)
- High-risk EGV, defined as F2, F3, or with red-color signs, diagnosed by endoscopy within 6 months before screening
- Active peptic ulcer disease diagnosed by endoscopy within 6 months be- fore screening
- FIB-4 index < 1.3 at screening
- Indicated for any anti-platelet therapy, such as history of cardiovascular events
- History of aspirin allergy
- History of bleeding disorders, such as hemophilia
- Pregnancy or breast feeding
- Severe renal impairment, which is defined as eGFR < 30 mL/min/1.73 m²
- Any malignancies
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Interventions
Participants will be randomly assigned in a 1:1 ratio to receive daily low-dose (81mg) aspirin or a placebo
Participants will be randomly assigned in a 1:1 ratio to receive daily low-dose (81mg) aspirin or a placebo
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06935994