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New treatment option for Cirrhosis
Official title Apixaban-PK Trial: Preventing Portal Hypertension Complications in Cirrhosis
ClinicalTrials.gov ID: NCT07521332
What this study is testing
What is Apixaban?
Apixaban is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for cirrhosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Time commitment: about 24 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adults aged ≥18 years with diagnosed cirrhosis (any etiology), confirmed by histology, transient elastography (≥12.5 kPa), or consistent...
- 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...
- Screening esophagogastroduodenoscopy (EGD) performed within 6 months prior to enrollment. Patients with high-risk varices (large varices, red wale...
- Able to provide informed consent and comply with study procedures.
You likely can't join if
- Active gastrointestinal bleeding within 6 weeks prior to enrollment.
- 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
See the full eligibility criteria
- 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...
- Able to provide informed consent and comply with study procedures.
- Active gastrointestinal bleeding within 6 weeks prior to enrollment.
- 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.
- Child-Pugh class C or Child-Pugh score ≥10.
- History of hypersensitivity to apixaban or carvedilol.
- Pregnancy, breastfeeding, or unwillingness to use effective contraception during the study period.
- 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.
- Use of NSAIDs, SSRIs, or other medications that significantly increase bleeding risk, unless approved by the PI with clear risk-benefit justification.
- Active hepatocellular carcinoma (HCC) outside Milan criteria or with vascular invasion.
- Current or planned liver transplantation.
The study team makes the final eligibility decision.
Where it's taking place
- Hyderābād, Sindh, Pakistan
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hyderābād, Sindh, Pakistan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.