NCT07521332RecruitingPhase 4
Apixaban-PK Trial: Preventing Portal Hypertension Complications in Cirrhosis
Apixaban Plus Carvedilol to Prevent Portal Hypertension Complications in Cirrhosis: A Randomized Single-Blind Placebo-Controlled Trial at AIMS, Hyderabad, Pakistan
Source: ClinicalTrials.gov · Last updated 9 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 220 (estimated)
- First submitted
- 31 Mar 2026
- Start date
- 1 Apr 2026
- Primary completion date
- 1 Apr 2027
- Lead sponsor
- Asian Institute Of Medical Sciences
- Diseases
- High blood pressure
- NCT number
- NCT07521332
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 220
- From 1 Apr 2026 to the primary completion date, 1 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active gastrointestinal bleeding within 6 weeks prior to enrollment.
- Concurrent anticoagulant or antiplatelet therapy (including aspirin, clopidogrel, warfarin, or other DOACs) that cannot be safely discontinued. A washout period of at least 5 half-lives is required before randomization.
- Current or planned liver transplantation.
Other illness
- History of hypersensitivity to apixaban or carvedilol.
- Use of NSAIDs, SSRIs, or other medications that significantly increase bleeding risk, unless approved by the PI with clear risk-benefit justification.
Lab values
- High bleeding risk:
- Platelet count \<50,000/µL at baseline
- INR \>1.8 (or \>2.0 if secondary to cirrhosis without additional coagulopathy)
- Active peptic ulcer disease
- History of intracranial hemorrhage or hemorrhagic stroke
- Known bleeding diathesis
- Severe renal impairment (eGFR \< 30 mL/min/1.73 m²) or on dialysis.
Other
- Child-Pugh class C or Child-Pugh score ≥10.
- Pregnancy, breastfeeding, or unwillingness to use effective contraception during the study period.
- Active hepatocellular carcinoma (HCC) outside Milan criteria or with vascular invasion.
Who the study is looking for
- Adults aged ≥18 years with diagnosed cirrhosis (any etiology), confirmed by histology, transient elastography (≥12.5 kPa), or consistent clinical/imaging findings.
- Evidence of portal hypertension, defined by:
- Clinical: presence of varices on endoscopy, ascites, or splenomegaly with thrombocytopenia.
- Compensated or early decompensated cirrhosis (Child-Pugh B 7-10), with stable liver function defined as no change in Child-Pugh score \>1 point in the preceding 3 months.
- Screening esophagogastroduodenoscopy (EGD) performed within 6 months prior to enrollment. Patients with high-risk varices (large varices, red wale signs, or history of variceal bleeding) must undergo endoscopic variceal band ligation to obliteration before randomization.
- Able to provide informed consent and comply with study procedures.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Asian Institute of Medical Sciences Coordinator of this site? Confirm its status | Hyderābād | Pakistan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.