Aspirin 81 mg Enteric Coated Tab - 1 tablet: Participants will be randomly assigned in a 1:1 ratio to receive daily low-dose (81mg) aspirin or a placebo
Placebo: Participants will be randomly assigned in a 1:1 ratio to receive daily low-dose (81mg) aspirin or a placebo
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 bleeding disorders, such as hemophilia
12. Pregnancy or breast feeding
13. Severe renal impairment, which is defined as eGFR \< 30 mL/min/1.73 m²
14. Any malignancies
Primary outcome measure(s)
Mean absolute change of VCTE-estimated LSM — Week 48 The surrogate primary endpoint is mean absolute change of VCTE-estimated LSM (kPa).
Cumulative incidence of MASLD-related clinical outcomes — Week 240 The clinical-outcome primary endpoint is the cumulative incidence (%) of any MASLD-related adverse outcomes, including LSM progression \>= 5 kPa, liver decompensation, HCC development, cardiovascular events, and death.
Trial sites (1)
Facility
City
Region
Status
Taichung Veterans General Hospital
Taichung
Taiwan
Recruiting
More Taichung Veterans General Hospital trials in Taiwan
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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