Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06935994

Aspirin for Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease

Led by Taichung Veterans General Hospital · Updated on 2025-05-11

120

Participants Needed

1

Research Sites

399 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Aspirin for Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosed with MASLD according to Delphi consensus with at least one of five cardiometabolic criteria
Not Eligible

You will not qualify if you...

  • Consuming alcohol at an average of 20 g/day or more for women, or 30 g/day or more for men
  • HbA1c level 9.0% or higher
  • Other chronic liver diseases such as hepatitis B or C, autoimmune hepatitis, Wilson's disease
  • Liver decompensation classified as Child-Pugh class B or C
  • Liver cirrhosis with significant portal hypertension (low platelet count, enlarged spleen, or varices)
  • High-risk esophageal or gastric varices diagnosed by endoscopy within 6 months before screening
  • Active peptic ulcer disease diagnosed by endoscopy within 6 months before screening
  • FIB-4 index less than 1.3 at screening
  • Indication for any anti-platelet therapy due to cardiovascular history
  • History of aspirin allergy
  • History of bleeding disorders such as hemophilia
  • Pregnancy or breastfeeding
  • Severe kidney impairment with eGFR less than 30 mL/min/1.73 m²
  • Any malignancies

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Taichung Veterans General Hospital

Taichung, Taiwan, Taiwan, 40705

Actively Recruiting

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Research Team

T

Teng-Yu Lee, MD, MBA, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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