Comparative Effectiveness and Safety of Apixaban, Rivaroxaban, and Warfarin in Patients With Cirrhosis and Atrial Fibrillation : A Nationwide Cohort Study.
Tracey G Simon, Daniel E Singer, Yichi Zhang...
https://pubmed.ncbi.nlm.nih.gov/38976880Actively Recruiting
Phase 4
Age: 18Years +
All Genders
ID07521332
Apixaban Plus Carvedilol to Prevent Portal Hypertension Complications in Cirrhosis A Randomized Single-Blind Placebo-Controlled Trial at AIMS Hyderabad Pakistan
Led by Asian Institute Of Medical Sciences · Updated on 2026-04-09
220
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Apixaban-PK Trial: Preventing Portal Hypertension Complications in Cirrhosis
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 618 years with diagnosed cirrhosis confirmed by biopsy, transient elastography, or consistent clinical/imaging findings
- Evidence of portal hypertension such as varices on endoscopy, ascites, or splenomegaly with low platelet count
- Compensated or early decompensated cirrhosis (Child-Pugh B 7-10) with stable liver function in the past 3 months
- Esophagogastroduodenoscopy (EGD) performed within 6 months before enrollment
- Patients with high-risk varices must have endoscopic variceal band ligation before randomization
- Able to give informed consent and follow study procedures
You will not qualify if you...
- Active gastrointestinal bleeding within 6 weeks before enrollment
- High bleeding risk including low platelet count (<50,000/µL), high INR (>1.8), active peptic ulcer, history of brain bleeding or bleeding disorders
- Severe kidney impairment (eGFR <30 mL/min/1.73 m2) or on dialysis
- Child-Pugh class C or score 610
- Allergy to apixaban or carvedilol
- Pregnancy, breastfeeding, or not using effective contraception
- Current use of anticoagulant or antiplatelet drugs that cannot be stopped safely
- Use of medications increasing bleeding risk unless approved by the investigator
- Active liver cancer outside accepted criteria or with blood vessel invasion
- Current or planned liver transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 months
Participants take apixaban or placebo twice daily plus carvedilol with dose adjustments. Carvedilol is titrated every 2 to 4 weeks based on heart rate and blood pressure. Participants are closely monitored for safety and efficacy during this period.
Baseline visit, safety telephone call at 2 weeks, and visits at 1, 3, 6, 9, and 12 months
Follow-up
Duration - 12 months
Participants are monitored for portal hypertension-related complications and safety outcomes through regular assessments and imaging during the follow-up period after treatment.
Visits coincide with treatment visits at 1, 3, 6, 9, and 12 months
Trial Site Locations
Total: 1 location
1
Asian Institute of Medical Sciences
Hyderābād, Sindh, Pakistan, 71000
Actively Recruiting
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Research Team
F
Fatima Nadeem Dr, Pharm-D, Mphil
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
[Non-invasive evaluation and prediction of portal hypertension: focusing on disease progression and outcome].
P S Xu, M C Wang, J J Chen...
https://pubmed.ncbi.nlm.nih.gov/41167763Screening and management of portal hypertension and varices in cirrhosis: Expert perspectives.
Robert S Brown, Kimberly A Brown, Steve Flamm...
https://pubmed.ncbi.nlm.nih.gov/40178492Carvedilol decreases hepatic vascular resistance by reducing fibrogenesis and reversing endothelial dysfunction in cirrhotic rats.
Yeldos Nulan, Eric Felli, Sonia-Emilia Selicean...
https://pubmed.ncbi.nlm.nih.gov/41659769Carvedilol is associated with lower mortality than other nonselective beta-blockers in patients with cirrhosis.
Michael J Mullarkey, Gerald O Ogola, Sumeet K Asrani...
https://pubmed.ncbi.nlm.nih.gov/40557192Preventing First and Further Decompensation in Advanced Chronic Liver Disease.
Leonardo Corrêa Süffert, Bernardo de Faria Moraes, Guilherme Grossi Lopes Cançado
https://pubmed.ncbi.nlm.nih.gov/41773498Comparison of Carvedilol to Propranolol in Reduction of Hepatic Venous Pressure Gradient in Liver Cirrhosis: A Meta-Analysis.
Amey Joshi, Hafsa Arshad Azam Raja, Poulami Roy...
https://pubmed.ncbi.nlm.nih.gov/40387434