CirrhosisPhase 4APIXABAN-PKNCT07521332
Apixaban-PK Trial: Preventing Portal Hypertension Complications in Cirrhosis
A Phase 4 study testing Apixaban and Carvedilol in people with Cirrhosis and Esophageal and Gastric Varices, run by Asian Institute Of Medical Sciences at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Esophageal and Gastric Varices, Ascites
- What is being tested?
- Apixaban and Carvedilol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2026to 1 Apr 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Asian Institute of Medical Sciences
Hyderābād, Sindh, 71000
Dr Fatima, 03080744996, fatima.nadeem229@amalacademy.org
sadikmemon@gmail.com
About this study
Official title: Apixaban Plus Carvedilol to Prevent Portal Hypertension Complications in Cirrhosis: A Randomized Single-Blind Placebo-Controlled Trial at AIMS, Hyderabad, Pakistan
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.
Read the detailed description
The APIXABAN-PK trial is a prospective, randomized, single-blind, placebo-controlled study conducted at the Asian Institute of Medical Sciences (AIMS) Hospital in Hyderabad, Pakistan. The study aims to evaluate the efficacy and safety of apixaban, a direct factor Xa inhibitor, in combination with carvedilol compared to carvedilol alone (with placebo) for preventing portal hypertension-related complications in patients with cirrhosis.
Patients with confirmed cirrhosis and evidence of portal hypertension (Child-Pugh B 7-10) are eligible. Participants undergo screening, including esophagogastroduodenoscopy (EGD) within six months prior to enrollment. Those with high-risk varices receive endoscopic variceal band ligation to obliteration before randomization to ensure baseline safety.
Eligible participants are randomized in a 1:1 ratio to one of two groups:
Intervention Group: Apixaban 2.5 mg orally twice daily plus carvedilol (titrated according to a protocol-defined schedule).
Control Group: Placebo (matching apixaban) orally twice daily plus carvedilol (titrated according to the same schedule).
Carvedilol is initiated at 6.25 mg once daily and titrated every 2-4 weeks based on heart rate and blood pressure, aiming for a maintenance dose of 12.5 mg twice daily, as tolerated. Dose adjustments are made for hypotension or bradycardia.
All participants are followed for 12 months. Study visits occur at baseline, 2 weeks (safety telephone call), and 1, 3, 6, 9, and 12 months. Assessments include vital signs, laboratory tests (complete blood count, liver and renal function, international normalized ratio), and imaging (abdominal ultrasound with Doppler and transient elastography at specified intervals). Adherence is monitored via pill counts and patient diaries.
The primary outcome is the first occurrence of portal hypertension-related complications (variceal bleeding, ascites, hepatic encephalopathy, portal vein thrombosis, or liver-related death) within 12 months. Secondary outcomes include bleeding events (major and minor), time to first decompensation or hospitalization, all-cause and liver-related mortality, and changes in non-invasive markers of portal hypertension (e.g., liver stiffness, platelet count).
Safety is closely monitored through routine assessments and an independent Data Safety Monitoring Board (DSMB). The DSMB reviews unblinded safety data after 50% of participants have completed 6 months of follow-up, with predefined stopping rules for excessive bleeding or mortality. Adverse events are graded using CTCAE v6.0 criteria.
Statistical analysis will be performed on an intention-to-treat basis. The primary endpoint (time to first complication) will be analyzed using Kaplan-Meier survival curves, log-rank tests, and Cox proportional hazards regression. The study aims to enroll 220 participants to account for anticipated dropout, with 100 participants per arm required to detect a 50% relative risk reduction in the primary outcome (two-sided α = 0.05, power = 80%). Enrollment is planned over 12 months, with a total study duration of 24 months.
This investigator-initiated trial is sponsored by the Asian Institute of Medical Sciences and is registered on ClinicalTrials.gov. Results will be submitted for publication within 12 months of study completion, regardless of outcome, in accordance with ICMJE guidelines.
- Conditions
- Cirrhosis, Esophageal and Gastric Varices, Ascites, Hepatic Encephalopathy, Portal Vein Thrombosis, Portal Hypertension
- Being tested
- Apixaban, Carvedilol, Placebo
- Keywords
- apixaban, carvedilol, cirrhosis, portal hypertension, direct oral anticoagulant, variceal bleeding, hepatic decompensation, portal vein thrombosis, randomized controlled trial, Pakistan, Factor Xa Inhibitor, non-selective beta-blocker, prevention, liver disease
- Medical subject headings
- Fibrosis, Esophageal and Gastric Varices, Ascites, Hepatic Encephalopathy, Hypertension, Portal, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApixabanDrug
Apixaban 2.5 mg oral tablet taken twice daily for 12 months. Apixaban is a direct factor Xa inhibitor that blocks thrombin generation and clot formation through inhibition of the coagulation cascade. Dose adjustment: continue 2.5 mg twice daily if eGFR ≥30 mL/min/1.73 m²; if eGFR 15-29 mL/min/1.73 m², continue with close monitoring; if eGFR <15 mL/min/1.73 m², discontinue. Withheld in case of major bleeding or severe hepatic decompensation.
CarvedilolDrug
Carvedilol oral tablet titrated according to protocol-defined schedule. Initiated at 6.25 mg once daily at baseline. Titrated every 2-4 weeks based on heart rate and blood pressure: 6.25 mg twice daily at week 2, 12.5 mg twice daily at week 4, with target maintenance dose of 12.5 mg twice daily. Dose may be reduced or withheld if heart rate <55 bpm, systolic blood pressure <90 mmHg, or symptomatic hypotension develops.
PlaceboDrug
Placebo oral tablet matching apixaban in appearance, taken twice daily for 12 months. No active ingredient.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group: Apixaban + Carvedilol | Experimental | Apixaban, Carvedilol Receives: Drug: Apixaban; Drug: Carvedilol |
| Control Group: Placebo + Carvedilol | Placebo comparator | Placebo, Carvedilol Receives: Drug: Carvedilol; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
First Occurrence of Portal Hypertension-Related Complications
Time to first occurrence of a composite of portal hypertension-related complications, defined as variceal bleeding, ascites, hepatic encephalopathy, portal vein thrombosis, or liver-related death, within 12 months of randomization.
Measured: 12 months
Secondary outcomes (1)
Major and Minor Bleeding Events
Incidence of major and minor bleeding events attributable to apixaban in combination with carvedilol. Major bleeding is defined by ISTH criteria (fatal bleeding, symptomatic bleeding in a critical area, bleeding causing a fall in hemoglobin ≥2 g/dL, or requiring transfusion of ≥2 units of packed red blood cells). Minor bleeding is defined as any overt bleeding not meeting major criteria.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start1 Apr 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, randomized, single-blind, placebo-controlled trial with parallel assignment. Eligible participants with cirrhosis and portal hypertension (Child-Pugh A or B ≤9) are randomized 1:1 to two arms. Intervention Arm: apixaban 2.5 mg twice daily plus carvedilol titrated to 12.5 mg twice daily. Control Arm: matching placebo twice daily plus carvedilol titrated identically. Randomization uses a computer-generated sequence with permuted blocks; allocation is concealed via centralized web-based system accessible only to unblinded pharmacist. Participants are blinded; investigators and pharmacy personnel are unblinded. All participants are followed 12 months with visits at baseline, 2 weeks (safety call), and 1, 3, 6, 9, and 12 months. Analysis is intention-to-treat. An independent DSMB reviews unblinded safety data after 50% of participants complete 6 months, with predefined stopping rules for excessive bleeding or mortality.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute Of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad sadik memon, Asian Institute Of Medical Sciences
- Investigators
- Sadik Memon, MBBS,MRCP,FCPS, Principal investigator, Asian Institute Of Medical SciencesDr. Fatima Nadeem, Pharm-D, Mphil, Study director, Asian Institute Of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07521332
- Sponsor's protocol ID
- AIMS/ERC/9853/26
- Acronym
- APIXABAN-PK
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared because: This is a single-center investigator-initiated trial without infrastructure for external data sharing The protocol and informed consent do not include provisions for sharing IPD with external researchers Institutional policy does not support IPD sharing for this study Aggregate results will be published per ICMJE guidelines
Publications
Simon TG, Singer DE, Zhang Y, Mastrorilli JM, Cervone A, DiCesare E, Lin KJ. Comparative Effectiveness and Safety of Apixaban, Rivaroxaban, and Warfarin in Patients With Cirrhosis and Atrial Fibrillation : A Nationwide Cohort Study. Ann Intern Med. 2024 Aug;177(8):1028-1038. doi: 10.7326/M23-3067. Epub 2024 Jul 9.
PubMed 38976880Xu PS, Wang MC, Chen JJ, Wang HY. [Non-invasive evaluation and prediction of portal hypertension: focusing on disease progression and outcome]. Zhonghua Gan Zang Bing Za Zhi. 2025 Oct 20;33(10):928-933. doi: 10.3760/cma.j.cn501113-20250726-00295. Chinese.
PubMed 41167763Brown RS Jr, Brown KA, Flamm S, Bejarano RE, Rahimi RS, Singal AK, Rockey DC. Screening and management of portal hypertension and varices in cirrhosis: Expert perspectives. Hepatol Commun. 2025 Apr 3;9(4):e0682. doi: 10.1097/HC9.0000000000000682. eCollection 2025 Apr 1.
PubMed 40178492Nulan Y, Felli E, Selicean SE, Prampolini M, Berzigotti A, Gracia-Sancho J, Bosch J. Carvedilol decreases hepatic vascular resistance by reducing fibrogenesis and reversing endothelial dysfunction in cirrhotic rats. JHEP Rep. 2025 Nov 20;8(3):101681. doi: 10.1016/j.jhepr.2025.101681. eCollection 2026 Mar.
PubMed 41659769Mullarkey MJ, Ogola GO, Asrani SK, Volk ML. Carvedilol is associated with lower mortality than other nonselective beta-blockers in patients with cirrhosis. Proc (Bayl Univ Med Cent). 2025 Apr 25;38(4):412-418. doi: 10.1080/08998280.2025.2491220. eCollection 2025.
PubMed 40557192Suffert LC, de Faria Moraes B, Cancado GGL. Preventing First and Further Decompensation in Advanced Chronic Liver Disease. Liver Int. 2026 Apr;46(4):e70568. doi: 10.1111/liv.70568.
PubMed 41773498Joshi A, Raja HAA, Roy P, Latif F, Reji RG, Deb N, Mui RK, Shady A. Comparison of Carvedilol to Propranolol in Reduction of Hepatic Venous Pressure Gradient in Liver Cirrhosis: A Meta-Analysis. J Gastroenterol Hepatol. 2025 Jun;40(6):1409-1418. doi: 10.1111/jgh.16999. Epub 2025 May 19.
PubMed 40387434
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apixaban Plus Carvedilol to Prevent Portal Hypertension Complications in Cirrhosis: A Randomized Single-Blind Placebo-Controlled Trial at AIMS, Hyderabad, Pakistan
- ClinicalTrials.gov ID
- NCT07521332
- Acronym / sponsor ID
- APIXABAN-PK / AIMS/ERC/9853/26
- Conditions
- Cirrhosis, Esophageal and Gastric Varices, Ascites, Hepatic Encephalopathy, Portal Vein Thrombosis, Portal Hypertension
- Keywords
- apixaban, carvedilol, cirrhosis, portal hypertension, direct oral anticoagulant, variceal bleeding, hepatic decompensation, portal vein thrombosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Asian Institute Of Medical SciencesUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The APIXABAN-PK trial is a prospective, randomized, single-blind, placebo-controlled study conducted at the Asian Institute of Medical Sciences (AIMS) Hospital in Hyderabad, Pakistan. The study aims to evaluate the efficacy and safety of apixaban, a direct factor Xa inhibitor, in combination with carvedilol compared to carvedilol alone (with placebo) for preventing portal hypertension-related complications in patients with cirrhosis.
Patients with confirmed cirrhosis and evidence of portal hypertension (Child-Pugh B 7-10) are eligible. Participants undergo screening, including esophagogastroduodenoscopy (EGD) within six months prior to enrollment. Those with high-risk varices receive endoscopic variceal band ligation to obliteration before randomization to ensure baseline safety.
Eligible participants are randomized in a 1:1 ratio to one of two groups:
Intervention Group: Apixaban 2.5 mg orally twice daily plus carvedilol (titrated according to a protocol-defined schedule).
Control Group: Placebo (matching apixaban) orally twice daily plus carvedilol (titrated according to the same schedule).
Carvedilol is initiated at 6.25 mg once daily and titrated every 2-4 weeks based on heart rate and blood pressure, aiming for a maintenance dose of 12.5 mg twice daily, as tolerated. Dose adjustments are made for hypotension or bradycardia.
All participants are followed for 12 months. Study visits occur at baseline, 2 weeks (safety telephone call), and 1, 3, 6, 9, and 12 months. Assessments include vital signs, laboratory tests (complete blood count, liver and renal function, international normalized ratio), and imaging (abdominal ultrasound with Doppler and transient elastography at specified intervals). Adherence is monitored via pill counts and patient diaries.
The primary outcome is the first occurrence of portal hypertension-related complications (variceal bleeding, ascites, hepatic encephalopathy, portal vein thrombosis, or liver-related death) within 12 months. Secondary outcomes include bleeding events (major and minor), time to first decompensation or hospitalization, all-cause and liver-related mortality, and changes in non-invasive markers of portal hypertension (e.g., liver stiffness, platelet count).
Safety is closely monitored through routine assessments and an independent Data Safety Monitoring Board (DSMB). The DSMB reviews unblinded safety data after 50% of participants have completed 6 months of follow-up, with predefined stopping rules for excessive bleeding or mortality. Adverse events are graded using CTCAE v6.0 criteria.
Statistical analysis will be performed on an intention-to-treat basis. The primary endpoint (time to first complication) will be analyzed using Kaplan-Meier survival curves, log-rank tests, and Cox proportional hazards regression. The study aims to enroll 220 participants to account for anticipated dropout, with 100 participants per arm required to detect a 50% relative risk reduction in the primary outcome (two-sided α = 0.05, power = 80%). Enrollment is planned over 12 months, with a total study duration of 24 months.
This investigator-initiated trial is sponsored by the Asian Institute of Medical Sciences and is registered on ClinicalTrials.gov. Results will be submitted for publication within 12 months of study completion, regardless of outcome, in accordance with ICMJE guidelines.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a prospective, randomized, single-blind, placebo-controlled trial with parallel assignment. Eligible participants with cirrhosis and portal hypertension (Child-Pugh A or B ≤9) are randomized 1:1 to two arms. Intervention Arm: apixaban 2.5 mg twice daily plus carvedilol titrated to 12.5 mg twice daily. Control Arm: matching placebo twice daily plus carvedilol titrated identically. Randomization uses a computer-generated sequence with permuted blocks; allocation is concealed via centralized web-based system accessible only to unblinded pharmacist. Participants are blinded; investigators and pharmacy personnel are unblinded. All participants are followed 12 months with visits at baseline, 2 weeks (safety call), and 1, 3, 6, 9, and 12 months. Analysis is intention-to-treat. An independent DSMB reviews unblinded safety data after 50% of participants complete 6 months, with predefined stopping rules for excessive bleeding or mortality.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group: Apixaban + Carvedilol | Experimental | Drug: Apixaban, Drug: CarvedilolApixaban, Carvedilol |
| Control Group: Placebo + Carvedilol | Placebo comparator | Drug: Carvedilol, Drug: PlaceboPlacebo, Carvedilol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- Active gastrointestinal bleeding within 6 weeks prior to enrollment.
- High bleeding risk:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApixabanApixaban 2.5 mg oral tablet taken twice daily for 12 months. Apixaban is a direct factor Xa inhibitor that blocks thrombin generation and clot formation through inhibition of the coagulation cascade. Dose adjustment: continue 2.5 mg twice daily if eGFR ≥30 mL/min/1.73 m²; if eGFR 15-29 mL/min/1.73 m², continue with close monitoring; if eGFR <15 mL/min/1.73 m², discontinue. Withheld in case of major bleeding or severe hepatic decompensation. | Drug | Intervention Group: Apixaban + Carvedilol |
| CarvedilolCarvedilol oral tablet titrated according to protocol-defined schedule. Initiated at 6.25 mg once daily at baseline. Titrated every 2-4 weeks based on heart rate and blood pressure: 6.25 mg twice daily at week 2, 12.5 mg twice daily at week 4, with target maintenance dose of 12.5 mg twice daily. Dose may be reduced or withheld if heart rate <55 bpm, systolic blood pressure <90 mmHg, or symptomatic hypotension develops. | Drug | Control Group: Placebo + Carvedilol, Intervention Group: Apixaban + Carvedilol |
| PlaceboPlacebo oral tablet matching apixaban in appearance, taken twice daily for 12 months. No active ingredient. | Drug | Control Group: Placebo + Carvedilol |
Primary outcome
First Occurrence of Portal Hypertension-Related Complications
Time frame: 12 months
Time to first occurrence of a composite of portal hypertension-related complications, defined as variceal bleeding, ascites, hepatic encephalopathy, portal vein thrombosis, or liver-related death, within 12 months of randomization.
1 secondary outcome
Major and Minor Bleeding Events
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Background: PubMed 38976880Simon TG, Singer DE, Zhang Y, Mastrorilli JM, Cervone A, DiCesare E, Lin KJ. Comparative Effectiveness and Safety of Apixaban, Rivaroxaban, and Warfarin in Patients With Cirrhosis and Atrial Fibrillation : A Nationwide Cohort Study. Ann Intern Med. 2024 Aug;177(8):1028-1038. doi: 10.7326/M23-3067. Epub 2024 Jul 9.
- Background: PubMed 41167763Xu PS, Wang MC, Chen JJ, Wang HY. [Non-invasive evaluation and prediction of portal hypertension: focusing on disease progression and outcome]. Zhonghua Gan Zang Bing Za Zhi. 2025 Oct 20;33(10):928-933. doi: 10.3760/cma.j.cn501113-20250726-00295. Chinese.
- Background: PubMed 40178492Brown RS Jr, Brown KA, Flamm S, Bejarano RE, Rahimi RS, Singal AK, Rockey DC. Screening and management of portal hypertension and varices in cirrhosis: Expert perspectives. Hepatol Commun. 2025 Apr 3;9(4):e0682. doi: 10.1097/HC9.0000000000000682. eCollection 2025 Apr 1.
- Background: PubMed 41659769Nulan Y, Felli E, Selicean SE, Prampolini M, Berzigotti A, Gracia-Sancho J, Bosch J. Carvedilol decreases hepatic vascular resistance by reducing fibrogenesis and reversing endothelial dysfunction in cirrhotic rats. JHEP Rep. 2025 Nov 20;8(3):101681. doi: 10.1016/j.jhepr.2025.101681. eCollection 2026 Mar.
- Background: PubMed 40557192Mullarkey MJ, Ogola GO, Asrani SK, Volk ML. Carvedilol is associated with lower mortality than other nonselective beta-blockers in patients with cirrhosis. Proc (Bayl Univ Med Cent). 2025 Apr 25;38(4):412-418. doi: 10.1080/08998280.2025.2491220. eCollection 2025.
- Background: PubMed 41773498Suffert LC, de Faria Moraes B, Cancado GGL. Preventing First and Further Decompensation in Advanced Chronic Liver Disease. Liver Int. 2026 Apr;46(4):e70568. doi: 10.1111/liv.70568.
- Background: PubMed 40387434Joshi A, Raja HAA, Roy P, Latif F, Reji RG, Deb N, Mui RK, Shady A. Comparison of Carvedilol to Propranolol in Reduction of Hepatic Venous Pressure Gradient in Liver Cirrhosis: A Meta-Analysis. J Gastroenterol Hepatol. 2025 Jun;40(6):1409-1418. doi: 10.1111/jgh.16999. Epub 2025 May 19.
- Official NCI CTCAE v6.0 criteria for adverse event grading and documentation.Link provided by the sponsor.
- Individual participant dataSharing planned: No. IPD will not be shared because: This is a single-center investigator-initiated trial without infrastructure for external data sharing The protocol and informed consent do not include provisions for sharing IPD with external researchers Institutional policy does not support IPD sharing for this study Aggregate results will be published per ICMJE guidelines
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sadik Memon, MBBS,MRCP,FCPS principal investigator
Asian Institute Of Medical Sciences
Dr. Fatima Nadeem, Pharm-D, Mphil study director
Asian Institute Of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Apixaban and Carvedilol in people with Cirrhosis and Esophageal and Gastric Varices, run by Asian Institute Of Medical Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatima Nadeem Dr, Pharm-D, Mphil (+923080744996, fatima.nadeem2401@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First Occurrence of Portal Hypertension-Related Complications (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07521332, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.