Apixaban, Warfarin and Aspirin Prevents Portal Vein Thrombosis in Patients After Laparoscopic Splenectomy（ESAWAAPT）
March 18, 2025 updated by: Guo-Qing Jiang, Northern Jiangsu People's Hospital
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
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
120
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
-
Yangzhou, Jiangsu, China, 225001
- Clinical Medical College of Yangzhou University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- History of Hemorrhagic stroke
- Pregnancy
- Uncontrolled Hypertension
- Human immunodeficiency virus (HIV) infection
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Apixaban with dipyridamole
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.
|
From postoperative day 3, patients will receive oral Apixaban 2.5mg bid for six months.
Other Names:
From postoperative day 3, patients will receive oral dipyridamole 25mg tid for three months.
Other Names:
From postoperative day 3, patients will receive subcutaneous injection of Low Molecular Weight Heparin (4100 IU) once daily for first five days.
Other Names:
|
|
Experimental: Warfarin with dipyridamole
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.
|
From postoperative day 3, patients will receive oral dipyridamole 25mg tid for three months.
Other Names:
From postoperative day 3, patients will receive subcutaneous injection of Low Molecular Weight Heparin (4100 IU) once daily for first five days.
Other Names:
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.
Other Names:
|
|
Experimental: Aspirin with dipyridamole
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.
|
From postoperative day 3, patients will receive oral dipyridamole 25mg tid for three months.
Other Names:
From postoperative day 3, patients will receive subcutaneous injection of Low Molecular Weight Heparin (4100 IU) once daily for first five days.
Other Names:
From postoperative day 3, patients will receive oral Aspirin Enterie Ccoated Tablets 100mg qd for six months.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
Two years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Proportions of patients who will show improvement in Child Pugh (>2 points) in three groups
Time Frame: Two years
|
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
|
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
|
Two years
|
|
Proportions of patients who will suffer from hepatocellular carcinoma in three groups.
Time Frame: Two years
|
Two years
|
|
Overall survival in three groups.
Time Frame: Two years
|
Two years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Dou-Sheng Bai Bai, MD, Clinical Medical College of Yangzhou University
- Study Director: Guo-Qing Jiang, MD, Clinical Medical College of Yangzhou University
- Principal Investigator: Sheng-Jie Jin, MD, Clinical Medical College of Yangzhou University
- Principal Investigator: Bao-Huan Zhou, MS, Clinical Medical College of Yangzhou University
- Principal Investigator: Tian-Ming Gao, MS, Clinical Medical College of Yangzhou University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 22, 2020
Primary Completion (Actual)
December 31, 2023
Study Completion (Actual)
December 31, 2023
Study Registration Dates
First Submitted
November 22, 2020
First Submitted That Met QC Criteria
November 22, 2020
First Posted (Actual)
November 27, 2020
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 18, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Pathologic Processes
- Digestive System Diseases
- Liver Diseases
- Embolism and Thrombosis
- Hypertension
- Thrombosis
- Venous Thrombosis
- Fibrosis
- Hypertension, Portal
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Inflammatory Agents
- Peripheral Nervous System Agents
- Protease Inhibitors
- Enzyme Inhibitors
- Fibrin Modulating Agents
- Antirheumatic Agents
- Sensory System Agents
- Analgesics, Non-Narcotic
- Analgesics
- Antipyretics
- Anti-Inflammatory Agents, Non-Steroidal
- Cyclooxygenase Inhibitors
- Fibrinolytic Agents
- Platelet Aggregation Inhibitors
- Vasodilator Agents
- Anticoagulants
- Factor Xa Inhibitors
- Antithrombins
- Serine Proteinase Inhibitors
- Phosphodiesterase Inhibitors
- Tinzaparin
- Aspirin
- Apixaban
- Warfarin
- Heparin
- Heparin, Low-Molecular-Weight
- Dalteparin
- Dipyridamole
Other Study ID Numbers
- YZUC-005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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