Could a blood thinner and heart pill prevent deadly liver complications?
NCT ID NCT07521332
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding the blood thinner apixaban to the heart drug carvedilol can prevent complications like bleeding, fluid buildup, and confusion in people with cirrhosis and high blood pressure in the liver. About 220 adults with stable cirrhosis will take either apixaban plus carvedilol or a placebo plus carvedilol for 12 months. Researchers will track how many develop serious liver-related events and monitor bleeding risks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Apixaban and carvedilol
- What this could lead to
- If it works, this combination could reduce serious complications like variceal bleeding and fluid buildup in people with cirrhosis.
- What could go wrong
- This is a single-blind, phase 4 trial in one hospital in Pakistan, so results may not apply broadly. Apixaban also raises bleeding risk, which is especially dangerous in liver disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 220 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Adults aged ≥18 years with diagnosed cirrhosis (any etiology), confirmed by histology, transient elastography (≥12.5 kPa), or consistent clinical/imaging findings. 2. Evidence of portal hypertension, defined by: Clinical: presence of varices on endoscopy, ascites, or splenomegaly with thrombocytopenia. 3. 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. 4. 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. 5. Able to provide informed consent and comply with study procedures. Exclusion Criteria: 1. Active gastrointestinal bleeding within 6 weeks prior to enrollment. 2. 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 3. Severe renal impairment (eGFR \< 30 mL/min/1.73 m²) or on dialysis. 4. Child-Pugh class C or Child-Pugh score ≥10. 5. History of hypersensitivity to apixaban or carvedilol. 6. Pregnancy, breastfeeding, or unwillingness to use effective contraception during the study period. 7. 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. 8. Use of NSAIDs, SSRIs, or other medications that significantly increase bleeding risk, unless approved by the PI with clear risk-benefit justification. 9. Active hepatocellular carcinoma (HCC) outside Milan criteria or with vascular invasion. 10. Current or planned liver transplantation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Asian Institute of Medical Sciences
RECRUITINGHyderābād, Sindh, 71000, Pakistan
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Other studies related to the condition(s) this trial covers.
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- Sound waves may replace the needle in liver scarring tests
- Ultrasound may replace invasive test for dangerous liver complication
- Could a wearable zapper quiet cirrhosis pain without drugs?
- A needle through the gut could replace the standard liver pressure test
- Spleen surgery may reshape cholesterol in cirrhosis