Apixaban-PK Trial: Preventing Portal Hypertension Complications in Cirrhosis

Sponsor
Asian Institute Of Medical Sciences
Study ID
NCT07521332
Phase
PHASE4
Status
Recruiting
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Conditions

  • Ascites
  • Cirrhosis
  • Esophageal and Gastric Varices
  • Hepatic Encephalopathy
  • Portal Hypertension
  • Portal Vein Thrombosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apixaban — DRUG
    Apixaban 2.5 mg oral tablet taken twice daily for 12 months. Apixaban is a direct factor Xa inhibitor that blocks thrombin generation and clot formation through inhibition of the coagulation cascade. Dose adjustment: continue 2.5 mg twice daily if eGFR ≥30 mL/min/1.73 m²; if eGFR 15-29 mL/min/1.73 m², continue with close monitoring; if eGFR \<15 mL/min/1.73 m², discontinue. Withheld in case of major bleeding or severe hepatic decompensation.
  • Carvedilol — DRUG
    Carvedilol oral tablet titrated according to protocol-defined schedule. Initiated at 6.25 mg once daily at baseline. Titrated every 2-4 weeks based on heart rate and blood pressure: 6.25 mg twice daily at week 2, 12.5 mg twice daily at week 4, with target maintenance dose of 12.5 mg twice daily. Dose may be reduced or withheld if heart rate \<55 bpm, systolic blood pressure \<90 mmHg, or symptomatic hypotension develops.
  • Placebo — DRUG
    Placebo oral tablet matching apixaban in appearance, taken twice daily for 12 months. No active ingredient.

Study Details

The APIXABAN-PK trial is a prospective, randomized, single-blind, placebo-controlled study designed to evaluate the efficacy and safety of apixaban in combination with carvedilol versus placebo with carvedilol in preventing portal hypertension-related complications in patients with cirrhosis. Conducted at the Gastroenterology and Hepatology Department and Clinical Trials Unit (CTU) of Asian Institute of Medical Sciences (AIMS) Hospital, Hyderabad, Pakistan, the trial will enroll eligible cirrhotic patients with portal hypertension. Participants will be followed for 12 months to monitor hepatic decompensation events, variceal bleeding, portal vein thrombosis, and mortality, while safety and tolerability of apixaban will be closely assessed. This study aims to provide local evidence for apixaban use in cirrhosis management in Pakistan.

Key Dates

First listed
Apr 9, 2026
Start date
Apr 1, 2026
Status verified
Mar 2026
Primary completion
Apr 1, 2027
Completion
Apr 1, 2028

Study Design

Enrollment
220 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Intervention Group: Apixaban + Carvedilol
    Apixaban, Carvedilol
  • Placebo Comparator: Control Group: Placebo + Carvedilol
    Placebo, Carvedilol

Primary Outcome Measure

First Occurrence of Portal Hypertension-Related Complications [ Time Frame: 12 months ]

Central Contacts

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