CirrhosisPhase 4NCT04645550
Apixaban, Warfarin and Aspirin Prevents Portal Vein Thrombosis in Patients After Laparoscopic Splenectomy（ESAWAAPT）
A Phase 4 study testing Apixaban, Warfarin and Aspirin in people with Cirrhosis and Splenectomy; Status, run by Northern Jiangsu People's Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine whether Apixaban, Warfarin and Aspirin Anticoagulation are effective and safe in Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients after Laparoscopic Splenectomy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Splenectomy; Status, Venous Thrombosis
- What is being tested?
- Apixaban, Warfarin and Aspirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 22 Nov 2020to 31 Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Splenomegaly with secondary hypersplenism
- No evidence of PVT or spleno-mesenteric thrombosis by ultrasound evaluation and angio-CT
- 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
- Base line INR >2
- Child-Pugh grade C
- Recent peptic ulcer disease
Show all 10Show fewer
- History of Hemorrhagic stroke
- Pregnancy
- Uncontrolled Hypertension
- Human immunodeficiency virus (HIV) infection
Trial locations and contacts
1 site in 1 country.
China1 site
Clinical Medical College of Yangzhou University
Yangzhou, Jiangsu, 225001
About this study
Official title: Efficacy and Safety of Apixaban, Warfarin and Aspirin Anticoagulation for Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients After Laparoscopic Splenectomy
The purpose of this study is to determine whether Apixaban, Warfarin and Aspirin Anticoagulation are effective and safe in Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients after Laparoscopic Splenectomy
Read the detailed description
After successful screening the cases of cirrhosis of liver irrespective of the etiology who have no portal vein thrombosis will be enrolled. The baseline Doppler parameter will be recorded and the patient will be randomized into apixaban, warfarin or aspirin group. From postoperative day three, patients in apixaban group will receive oral Apixaban 2.5mg bid for six months, patients in warfarin group will receive oral Warfarin 2.5mg qd with titration of dose to maintain a target INR of 2-3 for six months, patients in aspirin group will receive oral Aspirin Enterie Ccoated Tablets 100mg qd for six months. All groups will be along with five days of subcutaneous injection of Low Molecular Weight Heparin and three months of oral Dipyridamole. Every three months the Doppler screening for the occurrence of portal vein thrombus (PVT) or spleno-mesenteric thrombosis will be done for all patients. All groups will receive the therapy for six months irrespective of the Doppler findings in relation to portal vein thrombus occurrence. Then six months monitoring will be done in the three groups as per the primary or secondary outcome.
- Keywords
- Cirrhosis, Venous thrombosis, Portal Hypertension, Apixaban, Warfarin, Aspirin, Splenectomy, Laparoscopy
- Medical subject headings
- Fibrosis, Venous Thrombosis, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApixabanDrug
Also called ELIQUIS
From postoperative day 3, patients will receive oral Apixaban 2.5mg bid for six months.
WarfarinDrug
Also called Warfarin Sodium, Athrombine, COUMADIN, PANAWARFIN
From postoperative day 3, patients will receive oral Warfarin 2.5mg qd with titration of dose to maintain a target INR of 2-3 for six months.
AspirinDrug
Also called Acenterine, Acetard, Acetophen
From postoperative day 3, patients will receive oral Aspirin Enterie Ccoated Tablets 100mg qd for six months.
DipyridamoleDrug
Also called Gardoxin, Coribon, Curantyl, Dilaplus
From postoperative day 3, patients will receive oral dipyridamole 25mg tid for three months.
Low molecular weight heparinDrug
Also called Fraxiparine
From postoperative day 3, patients will receive subcutaneous injection of Low Molecular Weight Heparin (4100 IU) once daily for first five days.
| Study group | Role | What they receive |
|---|---|---|
| Apixaban with dipyridamole | Experimental | From postoperative day 3, patients will receive oral dipyridamole 25mg tid for three months along with subcutaneous injection of Low Molecular Weight Heparin (4100 IU) for first five days and Apixaban 2.5mg bid for six months. Receives: Drug: Apixaban; Drug: Dipyridamole; Drug: Low molecular weight heparin |
| Warfarin with dipyridamole | Experimental | From postoperative day 3, patients will receive dipyridamole 25mg tid for three months along with subcutaneous Low Molecular Weight Heparin Calcium injection for first five days and Warfarin 2.5mg qd with titration of dose to maintain a target INR of 2-3. Intially the INR will be monitored twice weekly with gradual escalation of dose to achieve target INR. After achieving the target INR, this is to be repeated every 4 weeks. The Doppler Ultra Sonography screening will be done every 3 months to assess the occurrence of portal vein thrombus, but the medications will be continue for six months irrespective of the occurrence of portal vein thrombus. Receives: Drug: Warfarin; Drug: Dipyridamole; Drug: Low molecular weight heparin |
| Aspirin with dipyridamole | Experimental | From postoperative day 3, patients will receive oral dipyridamole 25mg tid for three months along with subcutaneous injection of Low Molecular Weight Heparin (4100 IU) for first five days and Aspirin Enterie Ccoated Tablets 100mg qd for six months. Receives: Drug: Aspirin; Drug: Dipyridamole; Drug: Low molecular weight heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportions of patients who will suffer PVT or spleno-mesenteric thrombosis among oral anticoagulant Apixaban with dipyridamole group, oral Warfarin with dipyridamole group and oral Aspirin with dipyridamole group during the study period
Measured: Two years
Secondary outcomes (5)
Proportions of patients who will show improvement in Child Pugh (>2 points) in three groups
Measured: Two years
Proportions of patients who will show improvement in Model for End Stage Liver Disease (MELD)(>4 points) in three groups
Measured: Two years
Proportions of patients who will show decrease in hepatic decompensation defined as development of ascites, PSE, portal hypertensive bleeding, jaundice, spontaneous bacterial peritonitis, or systemic infection
Measured: Two years
Proportions of patients who will suffer from hepatocellular carcinoma in three groups.
Measured: Two years
Overall survival in three groups.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start22 Nov 2020
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
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 Bai, MD, Study chair, Clinical Medical College of Yangzhou UniversityGuo-Qing Jiang, MD, Study director, Clinical Medical College of Yangzhou UniversitySheng-Jie Jin, MD, Principal investigator, Clinical Medical College of Yangzhou UniversityBao-Huan Zhou, MS, Principal investigator, Clinical Medical College of Yangzhou UniversityTian-Ming Gao, MS, Principal investigator, Clinical Medical College of Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04645550
- Sponsor's protocol ID
- YZUC-005
- Status last verified
- Mar 2025
- First submitted
- 22 Nov 2020
- Last updated
- 21 Mar 2025
- 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 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Apixaban, Warfarin and Aspirin Anticoagulation for Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients After Laparoscopic Splenectomy
- ClinicalTrials.gov ID
- NCT04645550
- Acronym / sponsor ID
- YZUC-005
- Keywords
- Cirrhosis, Venous thrombosis, Portal Hypertension, Apixaban, Warfarin, Aspirin, Splenectomy, Laparoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Northern Jiangsu People's HospitalUniversity, hospital or other
- Study start
- 22 Nov 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 27 Nov 2020 (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, Warfarin and Aspirin Anticoagulation are effective and safe in Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients after Laparoscopic Splenectomy
Detailed description
After successful screening the cases of cirrhosis of liver irrespective of the etiology who have no portal vein thrombosis will be enrolled. The baseline Doppler parameter will be recorded and the patient will be randomized into apixaban, warfarin or aspirin group. From postoperative day three, patients in apixaban group will receive oral Apixaban 2.5mg bid for six months, patients in warfarin group will receive oral Warfarin 2.5mg qd with titration of dose to maintain a target INR of 2-3 for six months, patients in aspirin group will receive oral Aspirin Enterie Ccoated Tablets 100mg qd for six months. All groups will be along with five days of subcutaneous injection of Low Molecular Weight Heparin and three months of oral Dipyridamole. Every three months the Doppler screening for the occurrence of portal vein thrombus (PVT) or spleno-mesenteric thrombosis will be done for all patients. All groups will receive the therapy for six months irrespective of the Doppler findings in relation to portal vein thrombus occurrence. Then six months monitoring will be done in the three groups as per the primary or secondary outcome.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Apixaban with dipyridamole | Experimental | Drug: Apixaban, Drug: Dipyridamole, Drug: Low molecular weight heparinFrom postoperative day 3, patients will receive oral dipyridamole 25mg tid for three months along with subcutaneous injection of Low Molecular Weight Heparin (4100 IU) for first five days and Apixaban 2.5mg bid for six months. |
| Warfarin with dipyridamole | Experimental | Drug: Warfarin, Drug: Dipyridamole, Drug: Low molecular weight heparinFrom postoperative day 3, patients will receive dipyridamole 25mg tid for three months along with subcutaneous Low Molecular Weight Heparin Calcium injection for first five days and Warfarin 2.5mg qd with titration of dose to maintain a target INR of 2-3. Intially the INR will be monitored twice weekly with gradual escalation of dose to achieve target INR. After achieving the target INR, this is to be repeated every 4 weeks. The Doppler Ultra Sonography screening will be done every 3 months to assess the occurrence of portal vein thrombus, but the medications will be continue for six months irrespective of the occurrence of portal vein thrombus. |
| Aspirin with dipyridamole | Experimental | Drug: Aspirin, Drug: Dipyridamole, Drug: Low molecular weight heparinFrom postoperative day 3, patients will receive oral dipyridamole 25mg tid for three months along with subcutaneous injection of Low Molecular Weight Heparin (4100 IU) for first five days and Aspirin Enterie Ccoated Tablets 100mg qd for six months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A clinical, radiological or histologic diagnosis of cirrhosis of any etiology
- Splenomegaly with secondary hypersplenism
- No evidence of PVT or spleno-mesenteric thrombosis by ultrasound evaluation and angio-CT
- Informed consent to participate in the study
Key exclusion criteria (10 listed)
- Hepatocellular carcinoma or any other malignancy
- Hypercoagulable state other than the liver disease related
- DRUGS- oral contraceptives, anticoagulation or anti-platelet drugs
- Base line INR >2
- Child-Pugh grade C
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 |
|---|---|---|
| ApixabanAlso: ELIQUISFrom postoperative day 3, patients will receive oral Apixaban 2.5mg bid for six months. | Drug | Apixaban with dipyridamole |
| WarfarinAlso: Warfarin Sodium, Athrombine, COUMADIN, PANAWARFINFrom postoperative day 3, patients will receive oral Warfarin 2.5mg qd with titration of dose to maintain a target INR of 2-3 for six months. | Drug | Warfarin with dipyridamole |
| AspirinAlso: Acenterine, Acetard, AcetophenFrom postoperative day 3, patients will receive oral Aspirin Enterie Ccoated Tablets 100mg qd for six months. | Drug | Aspirin with dipyridamole |
| DipyridamoleAlso: Gardoxin, Coribon, Curantyl, DilaplusFrom postoperative day 3, patients will receive oral dipyridamole 25mg tid for three months. | Drug | Apixaban with dipyridamole, Aspirin with dipyridamole, Warfarin with dipyridamole |
| Low molecular weight heparinAlso: FraxiparineFrom postoperative day 3, patients will receive subcutaneous injection of Low Molecular Weight Heparin (4100 IU) once daily for first five days. | Drug | Apixaban with dipyridamole, Aspirin with dipyridamole, Warfarin with dipyridamole |
Primary outcome
Proportions of patients who will suffer PVT or spleno-mesenteric thrombosis among oral anticoagulant Apixaban with dipyridamole group, oral Warfarin with dipyridamole group and oral Aspirin with dipyridamole group during the study period
Time frame: Two years
5 secondary outcomes
Proportions of patients who will show improvement in Child Pugh (>2 points) in three groups
Time frame: Two years
Proportions of patients who will show improvement in Model for End Stage Liver Disease (MELD)(>4 points) in three groups
Time frame: Two years
Proportions of patients who will show decrease in hepatic decompensation defined as development of ascites, PSE, portal hypertensive bleeding, jaundice, spontaneous bacterial peritonitis, or systemic infection
Time frame: Two years
Proportions of patients who will suffer from hepatocellular carcinoma in three groups.
Time frame: Two years
Overall survival in three groups.
Time frame: Two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Dou-Sheng Bai Bai, MD study chair
Clinical Medical College of Yangzhou University
Guo-Qing Jiang, MD study director
Clinical Medical College of Yangzhou University
Sheng-Jie Jin, MD principal investigator
Clinical Medical College of Yangzhou University
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, Warfarin and Aspirin in people with Cirrhosis and Splenectomy; Status, 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 4 inclusion and 10 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: finished, as of the sponsor's last update on 21 Mar 2025. 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportions of patients who will suffer PVT or spleno-mesenteric thrombosis among oral anticoagulant Apixaban with dipyridamole group, oral Warfarin with dipyridamole group and oral Aspirin with dipyridamole group during the study period (time frame: Two years). 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 21 Mar 2025.