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

Cirrhosis Clinical Trial

Official title:

Efficacy and Safety of Apixaban, Warfarin and Aspirin Anticoagulation for Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients After Laparoscopic Splenectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04645550
• Other study ID #: YZUC-005
• Status: Completed
• Phase: Phase 4
• Start date: November 22, 2020
• Est. completion date: March 31, 2023

Study information

• Verified date: December 2023
• Source: Northern Jiangsu People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Hypertension
• Hypertension, Portal
• Splenectomy; Status
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• Apixaban
From postoperative day 3, patients will receive oral Apixaban 2.5mg bid for six months.
• 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.
• Aspirin
From postoperative day 3, patients will receive oral Aspirin Enterie Ccoated Tablets 100mg qd for six months.
• Dipyridamole
From postoperative day 3, patients will receive oral dipyridamole 25mg tid for three months.
• 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.

Locations

Country	Name	City	State
China	Clinical Medical College of Yangzhou University	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Northern Jiangsu People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportions of patients who will show improvement in Child Pugh (>2 points) in three groups		Two years
Secondary	Proportions of patients who will show improvement in Model for End Stage Liver Disease (MELD)(>4 points) in three groups		Two years
Secondary	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
Secondary	Proportions of patients who will suffer from hepatocellular carcinoma in three groups.		Two years
Secondary	Overall survival in three groups.		Two years