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

Sponsor
Yangzhou University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04645550
Collaborator
(none)
120
Enrollment
1
Location
3
Arms
24
Anticipated Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or DiseaseIntervention/TreatmentPhase
Phase 4

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

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Efficacy and Safety of Apixaban, Warfarin and Aspirin Anticoagulation for Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients After Laparoscopic Splenectomy
Actual Study Start Date :
Nov 22, 2020
Anticipated Primary Completion Date :
Nov 22, 2022
Anticipated Study Completion Date :
Nov 22, 2022

Arms and Interventions

ArmIntervention/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: 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
  • 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: 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: Aspirin
    From postoperative day 3, patients will receive oral Aspirin Enterie Ccoated Tablets 100mg qd for six months.
    Other Names:
  • Acenterine
  • Acetard
  • Acetophen
  • 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
  • Outcome Measures

    Primary Outcome Measures

    1. 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 [Two years]

    Secondary Outcome Measures

    1. Proportions of patients who will show improvement in Child Pugh (>2 points) in three groups [Two years]

    2. Proportions of patients who will show improvement in Model for End Stage Liver Disease (MELD)(>4 points) in three groups [Two years]

    3. 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 [Two years]

    4. Proportions of patients who will suffer from hepatocellular carcinoma in three groups. [Two years]

    5. Overall survival in three groups. [Two years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Clinical Medical College of Yangzhou UniversityYangzhouJiangsuChina225001

    Sponsors and Collaborators

    • Yangzhou University

    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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Guo-Qing Jiang, PhD, Yangzhou University
    ClinicalTrials.gov Identifier:
    NCT04645550
    Other Study ID Numbers:
    • YZUC-005
    First Posted:
    Nov 27, 2020
    Last Update Posted:
    Apr 1, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Guo-Qing Jiang, PhD, Yangzhou University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 1, 2022