Apixaban-PK Trial: Preventing Portal Hypertension Complications in Cirrhosis

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.

Timeline

Start

2026-04-01

Primary completion

2027-04-01

Completion

2028-04-01

Publications

• Background Simon TG, Singer DE, Zhang Y, Mastrorilli JM, Cervone A, DiCesare E, Lin KJ. Comparative Effectiveness and Safety of Apixaban, Rivaroxaban, and Warfarin in Patients With Cirrhosis and Atrial Fibrillation : A Nationwide Cohort Study. Ann Intern Med. 2024 Aug;177(8):1028-1038. doi: 10.7326/M23-3067. Epub 2024 Jul 9.
• Background Xu PS, Wang MC, Chen JJ, Wang HY. [Non-invasive evaluation and prediction of portal hypertension: focusing on disease progression and outcome]. Zhonghua Gan Zang Bing Za Zhi. 2025 Oct 20;33(10):928-933. doi: 10.3760/cma.j.cn501113-20250726-00295. Chinese.
• Background Brown RS Jr, Brown KA, Flamm S, Bejarano RE, Rahimi RS, Singal AK, Rockey DC. Screening and management of portal hypertension and varices in cirrhosis: Expert perspectives. Hepatol Commun. 2025 Apr 3;9(4):e0682. doi: 10.1097/HC9.0000000000000682. eCollection 2025 Apr 1.
• Background Nulan Y, Felli E, Selicean SE, Prampolini M, Berzigotti A, Gracia-Sancho J, Bosch J. Carvedilol decreases hepatic vascular resistance by reducing fibrogenesis and reversing endothelial dysfunction in cirrhotic rats. JHEP Rep. 2025 Nov 20;8(3):101681. doi: 10.1016/j.jhepr.2025.101681. eCollection 2026 Mar.
• Background Mullarkey MJ, Ogola GO, Asrani SK, Volk ML. Carvedilol is associated with lower mortality than other nonselective beta-blockers in patients with cirrhosis. Proc (Bayl Univ Med Cent). 2025 Apr 25;38(4):412-418. doi: 10.1080/08998280.2025.2491220. eCollection 2025.
• Background Suffert LC, de Faria Moraes B, Cancado GGL. Preventing First and Further Decompensation in Advanced Chronic Liver Disease. Liver Int. 2026 Apr;46(4):e70568. doi: 10.1111/liv.70568.
• Background Joshi A, Raja HAA, Roy P, Latif F, Reji RG, Deb N, Mui RK, Shady A. Comparison of Carvedilol to Propranolol in Reduction of Hepatic Venous Pressure Gradient in Liver Cirrhosis: A Meta-Analysis. J Gastroenterol Hepatol. 2025 Jun;40(6):1409-1418. doi: 10.1111/jgh.16999. Epub 2025 May 19.

Drugs

Indications