CirrhosisNCT07461532
Efficacy of Apixaban in Treating Portal Vein Thrombosis Occurring More Than One Year After LSD
A study testing Apixaban 2.5 MG in people with Cirrhosis and Splenectomy, run by Northern Jiangsu People's Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine whether Apixaban is effective and safe in the treatment of portal vein thrombosis Occurring more than one year after laparoscopic splenectomy and azygoportal disconnection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Splenectomy, Portal Vein Thrombosis
- What is being tested?
- Apixaban 2.5 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 30 Sep 2027
- Phase
- Interventional
- 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
- A clinical, radiological, or histologic diagnosis of cirrhosis of any etiology.
- Portal hypertension bleeding .
- Splenomegaly with secondary hypersplenism.
- No evidence of portal vein thrombosis by ultrasound evaluation and angio-CT prior to surgery.
- Underwent laparoscopic splenectomy at our center.
- Orally received 2.5 mg of apixaban (CTTQ, Nanjing, China) twice daily or a 100 mg aspirin tablet (Bayer, Leverkusen, Germany) once daily for 6 months from POD 3.
Show all 11Show fewer
- subcutaneous injections of low molecular weight heparin sodium (CSBio, Hebei, China) were administered for 5 days from POD 3
- Oral dipyridamole (Henan Furen, Henan, China) at a dosage of 25 mg, administered three times daily for 3 months from POD 3.
- Had no imaging evidence (Doppler ultrasound or CT) of portal vein thrombosis during postoperative months 6 to 12.
- Developed portal vein thrombosis after 12 months post-surgery.
- Provided informed consent to participate in the study.
Who cannot join
- Hepatocellular carcinoma or any other malignancy.
- Hypercoagulable state other than the liver disease related.
- DRUGS- oral contraceptives, anticoagulation or anti-platelet drugs.
- Child - Pugh C
- Recent peptic ulcer disease
- History of Hemorrhagic stroke
Show all 9Show fewer
- Pregnancy.
- Uncontrolled Hypertension
- Human immunodeficiency virus (HIV) infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Clinical Medical College
Yangzhou, Jiangsu, 225001
Guo-Qing Jiang, MD, +8651487373382, jgqing2003@hotmail.com
Dou-Sheng Bai, MD, bdsno1@hotmail.com
About this study
Official title: Efficacy of Apixaban in Treating Portal Vein Thrombosis Occurring More Than One Year After Laparoscopic Splenectomy and Azygoportal Disconnection
The purpose of this study is to determine whether Apixaban is effective and safe in the treatment of portal vein thrombosis Occurring more than one year after laparoscopic splenectomy and azygoportal disconnection.
Read the detailed description
If portal vein thrombosis occurs more than one year after and azygoportal disconnection, the patient will orally received 2.5 mg of apixaban (CTTQ, Nanjing, China) twice daily. Then, the efficacy of apixaban in treating portal vein thrombosis will be examined every three months using Doppler ultrasound screening or contrast-enhanced CT scans. If it is effective, the patient will continue to take apixaban.
- Conditions
- Cirrhosis, Splenectomy, Portal Vein Thrombosis, Hypertension, Portal
- Being tested
- Apixaban 2.5 MG
- Keywords
- Cirrhosis, Portal Vein Thrombosis, Portal Hypertension, Apixaban, Splenectomy, Laparoscopy, Hypersplenism, Azygoportal disconnection
- Medical subject headings
- Fibrosis, Hypertension, Portal, Hypersplenism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apixaban 2.5 MGDrug
If portal vein thrombosis occurs more than one year after laparoscopic splenectomy and azygoportal disconnection, the patient will orally received 2.5 mg of apixaban (CTTQ, Nanjing, China) twice daily. Then, Doppler ultrasound screening or contrast-enhanced CT scans will be used to evaluate the changes in portal vein thrombosis after apixaban treatment. If it is effective, patients will take apixaban all the time.
| Study group | Role | What they receive |
|---|---|---|
| Apixaban group | Experimental | If portal vein thrombosis occurs more than one year after laparoscopic splenectomy and azygoportal disconnection, the patient will orally received 2.5 mg of apixaban (CTTQ, Nanjing, China) twice daily. Then, Doppler ultrasound screening or contrast-enhanced CT scans will be used to evaluate the changes in portal vein thrombosis after apixaban treatment. If it is effective, patients will take apixaban all the time. Receives: Drug: Apixaban 2.5 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of complete recanalization of portal vein thrombosis
Proportion of complete recanalization of portal vein thrombosis
Measured: Follow-up of 6 months or greater
Secondary outcomes (1)
Proportion of partial recanalization of portal vein thrombosis
Proportion of partial recanalization of portal vein thrombosis
Measured: Follow-up of 6 months or greater
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Jiangsu People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guo-Qing Jiang, Northern Jiangsu People's Hospital
- Investigators
- Dou-Sheng Bai, Study chair, Clinical Medical College, Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07461532
- Sponsor's protocol ID
- YZUC-016
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Apixaban in Treating Portal Vein Thrombosis Occurring More Than One Year After Laparoscopic Splenectomy and Azygoportal Disconnection
- ClinicalTrials.gov ID
- NCT07461532
- Acronym / sponsor ID
- YZUC-016
- Conditions
- Cirrhosis, Splenectomy, Portal Vein Thrombosis, Hypertension, Portal
- Keywords
- Cirrhosis, Portal Vein Thrombosis, Portal Hypertension, Apixaban, Splenectomy, Laparoscopy, Hypersplenism, Azygoportal disconnection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Northern Jiangsu People's HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 10 Mar 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 purpose of this study is to determine whether Apixaban is effective and safe in the treatment of portal vein thrombosis Occurring more than one year after laparoscopic splenectomy and azygoportal disconnection.
Detailed description
If portal vein thrombosis occurs more than one year after and azygoportal disconnection, the patient will orally received 2.5 mg of apixaban (CTTQ, Nanjing, China) twice daily. Then, the efficacy of apixaban in treating portal vein thrombosis will be examined every three months using Doppler ultrasound screening or contrast-enhanced CT scans. If it is effective, the patient will continue to take apixaban.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apixaban group | Experimental | Drug: Apixaban 2.5 MGIf portal vein thrombosis occurs more than one year after laparoscopic splenectomy and azygoportal disconnection, the patient will orally received 2.5 mg of apixaban (CTTQ, Nanjing, China) twice daily. Then, Doppler ultrasound screening or contrast-enhanced CT scans will be used to evaluate the changes in portal vein thrombosis after apixaban treatment. If it is effective, patients will take apixaban all the time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- A clinical, radiological, or histologic diagnosis of cirrhosis of any etiology.
- Portal hypertension bleeding .
- Splenomegaly with secondary hypersplenism.
- No evidence of portal vein thrombosis by ultrasound evaluation and angio-CT prior to surgery.
- Underwent laparoscopic splenectomy at our center.
Key exclusion criteria (9 listed)
- Hepatocellular carcinoma or any other malignancy.
- Hypercoagulable state other than the liver disease related.
- DRUGS- oral contraceptives, anticoagulation or anti-platelet drugs.
- Child - Pugh C
- Recent peptic ulcer disease
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 |
|---|---|---|
| Apixaban 2.5 MGIf portal vein thrombosis occurs more than one year after laparoscopic splenectomy and azygoportal disconnection, the patient will orally received 2.5 mg of apixaban (CTTQ, Nanjing, China) twice daily. Then, Doppler ultrasound screening or contrast-enhanced CT scans will be used to evaluate the changes in portal vein thrombosis after apixaban treatment. If it is effective, patients will take apixaban all the time. | Drug | Apixaban group |
Primary outcome
Proportion of complete recanalization of portal vein thrombosis
Time frame: Follow-up of 6 months or greater
Proportion of complete recanalization of portal vein thrombosis
1 secondary outcome
Proportion of partial recanalization of portal vein thrombosis
Time frame: Follow-up of 6 months or greater
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 31 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Cirrhosis
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Recruiting
CirrhosisRx CDS System
Cirrhosis, Decision Support Systems, Clinical
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
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.
Dou-Sheng Bai study chair
Clinical Medical College, Yangzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apixaban 2.5 MG in people with Cirrhosis and Splenectomy, run by Northern Jiangsu People's Hospital at 1 site in China.
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 11 inclusion and 9 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 31 Mar 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 China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Guo-Qing Jiang, MD (+8651487373272, jgqing2003@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of complete recanalization of portal vein thrombosis (time frame: Follow-up of 6 months or greater). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2026.