Study of Apixaban Plus Carvedilol to Prevent Portal Hypertension Complications in Cirrhosis Randomized Single-Blind Placebo-Controlled Trial at AIMS Hospital, Hyderabad, Pakistan

What this Trial Is About

Researchers are evaluating the safety and effectiveness of apixaban combined with carvedilol compared to carvedilol alone in preventing complications related to portal hypertension in patients with cirrhosis. This is a prospective, randomized, single-blind, placebo-controlled study conducted at the Asian Institute of Medical Sciences Hospital in Hyderabad, Pakistan. The goal is to provide local evidence for using apixaban in managing cirrhosis and its complications, such as variceal bleeding and portal vein thrombosis. Participants are randomly assigned to one of two groups one receives apixaban 2.5 mg twice daily plus carvedilol, while the other receives a placebo plus carvedilol. Carvedilol doses start at 6.25 mg once daily and are gradually increased every 2 to 4 weeks to a target of 12.5 mg twice daily, based on heart rate and blood pressure. Those with high-risk varices undergo endoscopic band ligation before randomization for safety. The treatment and follow-up last for 12 months. During the study, participants have visits at baseline, 2 weeks, and at 1, 3, 6, 9, and 12 months. Assessments include vital signs, blood tests, abdominal ultrasound with Doppler, and transient elastography. Adherence is tracked through pill counts and diaries. Researchers will monitor the first occurrence of portal hypertension complications, bleeding events, hospitalizations, and mortality. Safety is carefully reviewed by an independent board throughout the trial.

Apixaban-PK Trial: Preventing Portal Hypertension Complications in Cirrhosis