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Could a blood thinner and heart pill prevent deadly liver complications?

NCT ID NCT07521332

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 220 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Asian Institute of Medical Sciences

    RECRUITING

    Hyderābād, Sindh, 71000, Pakistan

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