Clinical trial NCT04645550: Apixaban, Warfarin and Aspirin Prevents Portal Vein Thrombosis in Patients After Laparoscopic Splenectomy（ESAWAAPT）
Official title: Efficacy and Safety of Apixaban, Warfarin and Aspirin Anticoagulation for Prevention of Portal Vein Thrombosis in Liver Cirrhotic Patients After Laparoscopic Splenectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cirrhosis
Splenectomy; Status
Venous Thrombosis
Hypertension, Portal
Keywords: Cirrhosis
Venous thrombosis
Portal Hypertension
Apixaban
Warfarin
Aspirin
Splenectomy
Laparoscopy
Lead sponsor: Northern Jiangsu People's Hospital
Sponsor class: OTHER
First posted: 2020-11-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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.

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Two years
Secondary outcomes:
measure: Proportions of patients who will show improvement in Child Pugh (>2 points) in three groups
timeFrame: Two years
measure: Proportions of patients who will show improvement in Model for End Stage Liver Disease (MELD)(>4 points) in three groups
timeFrame: Two years
measure: 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
timeFrame: Two years
measure: Proportions of patients who will suffer from hepatocellular carcinoma in three groups.
timeFrame: Two years
measure: Overall survival in three groups.
timeFrame: Two years
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: Clinical Medical College of Yangzhou University
state: Jiangsu
Study officials:
affiliation: Clinical Medical College of Yangzhou University
name: Dou-Sheng Bai Bai, MD
role: STUDY_CHAIR
affiliation: Clinical Medical College of Yangzhou University
name: Guo-Qing Jiang, MD
role: STUDY_DIRECTOR
affiliation: Clinical Medical College of Yangzhou University
name: Sheng-Jie Jin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Medical College of Yangzhou University
name: Bao-Huan Zhou, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Medical College of Yangzhou University
name: Tian-Ming Gao, MS
role: PRINCIPAL_INVESTIGATOR
References: