Actively Recruiting
Apixaban-PK Trial: Preventing Portal Hypertension Complications in Cirrhosis
Led by Asian Institute Of Medical Sciences · Updated on 2026-04-09
220
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Apixaban-PK Trial: Preventing Portal Hypertension Complications in Cirrhosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older with diagnosed cirrhosis confirmed by histology, imaging, or clinical findings
- Evidence of portal hypertension such as varices on endoscopy, ascites, or splenomegaly with low platelet count
- Compensated or early decompensated cirrhosis with Child-Pugh B score between 7 and 10 and stable liver function (no significant score change in past 3 months)
- Screening esophagogastroduodenoscopy (EGD) performed within 6 months before enrollment
- Patients with high-risk varices must have completed variceal band ligation before randomization
- Ability to provide informed consent and follow study procedures
You will not qualify if you...
- Active gastrointestinal bleeding within 6 weeks before enrollment
- High bleeding risk including platelet count below 50,000/µL, INR above 1.8 (or above 2.0 if due to cirrhosis alone), active peptic ulcer disease, history of brain hemorrhage or stroke, or known bleeding disorders
- Severe kidney impairment (eGFR below 30 mL/min/1.73 m²) or dialysis
- Child-Pugh class C cirrhosis or Child-Pugh score of 10 or higher
- Allergy or hypersensitivity to apixaban or carvedilol
- Pregnancy, breastfeeding, or unwillingness to use effective contraception during the study
- Use of anticoagulant or antiplatelet medicines that cannot be stopped safely before enrollment
- Use of NSAIDs, SSRIs, or other drugs that increase bleeding risk without approval
- Active liver cancer outside accepted criteria or with blood vessel invasion
- Current or planned liver transplantation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Asian Institute of Medical Sciences
Hyderābād, Sindh, Pakistan, 71000
Actively Recruiting
Research Team
F
Fatima Nadeem Dr, Pharm-D, Mphil
CONTACT
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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