Apixaban plus carvedilol to prevent portal-hypertension complications in cirrhosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized, single-blind, placebo-controlled Phase 4 trial at the Asian Institute of Medical Sciences in Hyderabad, Pakistan. Eligible adults with cirrhosis and portal hypertension (Child-Pugh B, 7–10) are randomized 1:1 to apixaban 2.5 mg twice daily plus carvedilol (titrated per protocol) or matching placebo plus the same carvedilol regimen. Participants are followed for 12 months with visits at baseline, 1, 3, 6, 9, and 12 months and an early safety check at 2 weeks, tracking hepatic decompensation events, variceal bleeding, portal vein thrombosis, mortality, and safety/tolerability. High-risk varices are treated with band ligation to obliteration before randomization and safety monitoring for bleeding is emphasized throughout the study.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adults aged ≥18 years with diagnosed cirrhosis (any etiology), confirmed by histology, transient elastography (≥12.5 kPa), or consistent clinical/imaging findings.
2. Evidence of portal hypertension, defined by:

   Clinical: presence of varices on endoscopy, ascites, or splenomegaly with thrombocytopenia.
3. Compensated or early decompensated cirrhosis (Child-Pugh B 7-10), with stable liver function defined as no change in Child-Pugh score \>1 point in the preceding 3 months.
4. Screening esophagogastroduodenoscopy (EGD) performed within 6 months prior to enrollment. Patients with high-risk varices (large varices, red wale signs, or history of variceal bleeding) must undergo endoscopic variceal band ligation to obliteration before randomization.
5. Able to provide informed consent and comply with study procedures.

Exclusion Criteria:

1. Active gastrointestinal bleeding within 6 weeks prior to enrollment.
2. High bleeding risk:

   * Platelet count \<50,000/µL at baseline
   * INR \>1.8 (or \>2.0 if secondary to cirrhosis without additional coagulopathy)
   * Active peptic ulcer disease
   * History of intracranial hemorrhage or hemorrhagic stroke
   * Known bleeding diathesis
3. Severe renal impairment (eGFR \< 30 mL/min/1.73 m²) or on dialysis.
4. Child-Pugh class C or Child-Pugh score ≥10.
5. History of hypersensitivity to apixaban or carvedilol.
6. Pregnancy, breastfeeding, or unwillingness to use effective contraception during the study period.
7. Concurrent anticoagulant or antiplatelet therapy (including aspirin, clopidogrel, warfarin, or other DOACs) that cannot be safely discontinued. A washout period of at least 5 half-lives is required before randomization.
8. Use of NSAIDs, SSRIs, or other medications that significantly increase bleeding risk, unless approved by the PI with clear risk-benefit justification.
9. Active hepatocellular carcinoma (HCC) outside Milan criteria or with vascular invasion.
10. Current or planned liver transplantation.

Where it's running

• Asian Institute of Medical Sciences
  Hyderābād, Sindh, Pakistan Recruiting

Study contacts

• Principal investigator: Sadik Memon, MBBS,MRCP,FCPS — Asian Institute Of Medical Sciences
• Study coordinator: Fatima Nadeem Dr, Pharm-D, Mphil
• Email: fatima.nadeem2401@gmail.com
• Phone: +923080744996

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.