Apixaban, Warfarin and Aspirin Prevents Portal Vein Thrombosis in Patients After Laparoscopic Splenectomy（ESAWAAPT）

December 15, 2023 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

Conditions

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

  • China
    • 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.
Drug: Apixaban
From postoperative day 3, patients will receive oral Apixaban 2.5mg bid for six months.
Other Names:
  • ELIQUIS
Drug: Dipyridamole
From postoperative day 3, patients will receive oral dipyridamole 25mg tid for three months.
Other Names:
  • Gardoxin
  • Coribon
  • Curantyl
  • Dilaplus
Drug: Low molecular weight heparin
From postoperative day 3, patients will receive subcutaneous injection of Low Molecular Weight Heparin (4100 IU) once daily for first five days.
Other Names:
  • Fraxiparine
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.
Drug: Dipyridamole
From postoperative day 3, patients will receive oral dipyridamole 25mg tid for three months.
Other Names:
  • Gardoxin
  • Coribon
  • Curantyl
  • Dilaplus
Drug: Low molecular weight heparin
From postoperative day 3, patients will receive subcutaneous injection of Low Molecular Weight Heparin (4100 IU) once daily for first five days.
Other Names:
  • Fraxiparine
Drug: Warfarin
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:
  • Warfarin Sodium
  • Athrombine
  • COUMADIN
  • PANAWARFIN
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.
Drug: Dipyridamole
From postoperative day 3, patients will receive oral dipyridamole 25mg tid for three months.
Other Names:
  • Gardoxin
  • Coribon
  • Curantyl
  • Dilaplus
Drug: Low molecular weight heparin
From postoperative day 3, patients will receive subcutaneous injection of Low Molecular Weight Heparin (4100 IU) once daily for first five days.
Other Names:
  • Fraxiparine
Drug: Aspirin
From postoperative day 3, patients will receive oral Aspirin Enterie Ccoated Tablets 100mg qd for six months.
Other Names:
  • Acenterine
  • Acetard
  • Acetophen

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.

Sponsor

Northern Jiangsu People's Hospital

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)

March 31, 2023

Study Completion (Actual)

March 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 (Estimated)

December 21, 2023

Last Update Submitted That Met QC Criteria

December 15, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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