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

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ClinicalTrials.gov Identifier: NCT04645550
Recruitment Status : Recruiting
First Posted : November 27, 2020
Last Update Posted : February 11, 2022
Sponsor:
Information provided by (Responsible Party):
Guo-Qing Jiang, Yangzhou University

Study Description
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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 disease Intervention/treatment Phase
Cirrhosis Splenectomy; Status Venous Thrombosis Hypertension, Portal Drug: Apixaban Drug: Warfarin Drug: Aspirin Drug: Dipyridamole Drug: Low molecular weight heparin Phase 4

Detailed Description:
After successful screening the cases of cirrhosis of liver irrespective of the etiology who have non tumor 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 22, 2020
Estimated Primary Completion Date : November 22, 2022
Estimated Study Completion Date : November 22, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: 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 Name: 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 Name: Fraxiparine


Outcome Measures
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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 [ Time Frame: Two years ]

Secondary Outcome Measures :
  1. Proportions of patients who will show improvement in Child Pugh (>2 points) in three groups [ Time Frame: Two years ]
  2. Proportions of patients who will show improvement in Model for End Stage Liver Disease (MELD)(>4 points) in three groups [ Time Frame: 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 [ Time Frame: Two years ]
  4. Proportions of patients who will suffer from hepatocellular carcinoma in three groups. [ Time Frame: Two years ]
  5. Overall survival in three groups. [ Time Frame: Two years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04645550


Contacts
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Contact: Guo-Qing Jiang, MD 86-514-87373372 jgqing2003@hotmail.com
Contact: Dou-Sheng Bai, MD 86-514-87373375 bdsno1@hotmail.com

Locations
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China, Jiangsu
Clinical Medical College of Yangzhou University Recruiting
Yangzhou, Jiangsu, China, 225001
Contact: Guo-Qing Jiang, MS    86-514-87373372    jgqing2003@hotmail.com   
Contact: Dou-Sheng Bai, MD    86-514-87373375    bdsno1@hotmail.com   
Principal Investigator: Guo-Qing Jiang, MD         
Sub-Investigator: Sheng-Jie Jin, MD         
Sponsors and Collaborators
Yangzhou University
Investigators
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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
More Information
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Responsible Party: Guo-Qing Jiang, PhD, Yangzhou University
ClinicalTrials.gov Identifier: NCT04645550    
Other Study ID Numbers: YZUC-005
First Posted: November 27, 2020    Key Record Dates
Last Update Posted: February 11, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guo-Qing Jiang, Yangzhou University:
Cirrhosis
Venous thrombosis
Portal Hypertension
Apixaban
 Warfarin
Aspirin
Splenectomy
Laparoscopy
Additional relevant MeSH terms:
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Hypertension, Portal
Hypertension
Thrombosis
Venous Thrombosis
Fibrosis
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Liver Diseases
Digestive System Diseases
Embolism and Thrombosis
Aspirin
Heparin
Heparin, Low-Molecular-Weight
Tinzaparin
 Dalteparin
Dipyridamole
Warfarin
Apixaban
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action