Clinical Trial

Apixaban-PK Trial: Preventing Portal Hypertension Complications in Cirrhosis

Study acronym: APIXABAN-PK
Recruiting Phase 4
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Summary
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.
Trial Details
NCT Number NCT07521332
Lead Sponsor Asian Institute Of Medical Sciences
Conditions Cirrhosis, Esophageal and Gastric Varices, Ascites, Hepatic Encephalopathy, Portal Vein Thrombosis, Portal Hypertension
Enrollment 220 participants
Start Date 2026-04-01
Primary Completion 2027-04-01 (estimated)
Study Completion 2028-04-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-09