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

NCT04645550 | Completed Phase 4 DMC

• 1 other identifier: YZUC-005
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Cirrhosis; Venous thrombosis; Portal Hypertension; Apixaban; Warfarin; Aspirin; Splenectomy; Laparoscopy

Outcome Measures

Primary Outcomes (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 Outcomes (5)

• Proportions of patients who will show improvement in Child Pugh (>2 points) in three groups

  Two years

• Proportions of patients who will show improvement in Model for End Stage Liver Disease (MELD)(>4 points) in three groups

  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

  Two years

• Proportions of patients who will suffer from hepatocellular carcinoma in three groups.

  Two years

• Overall survival in three groups.

  Two years

Study Arms (3)

Apixaban with dipyridamole

EXPERIMENTAL

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; Drug: Dipyridamole; Drug: Low molecular weight heparin

Warfarin with dipyridamole

EXPERIMENTAL

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; Drug: Dipyridamole; Drug: Low molecular weight heparin

Aspirin with dipyridamole

EXPERIMENTAL

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; Drug: Dipyridamole; Drug: Low molecular weight heparin

Interventions

Apixaban DRUG

From postoperative day 3, patients will receive oral Apixaban 2.5mg bid for six months.

Also known as: ELIQUIS

Apixaban with dipyridamole

Warfarin DRUG

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.

Also known as: Warfarin Sodium, Athrombine, COUMADIN, PANAWARFIN

Warfarin with dipyridamole

Aspirin DRUG

From postoperative day 3, patients will receive oral Aspirin Enterie Ccoated Tablets 100mg qd for six months.

Also known as: Acenterine, Acetard, Acetophen

Aspirin with dipyridamole

Dipyridamole DRUG

From postoperative day 3, patients will receive oral dipyridamole 25mg tid for three months.

Also known as: Gardoxin, Coribon, Curantyl, Dilaplus

Apixaban with dipyridamole; Aspirin with dipyridamole; Warfarin with dipyridamole

Low molecular weight heparin DRUG

From postoperative day 3, patients will receive subcutaneous injection of Low Molecular Weight Heparin (4100 IU) once daily for first five days.

Also known as: Fraxiparine

Apixaban with dipyridamole; Aspirin with dipyridamole; Warfarin with dipyridamole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northern Jiangsu People's Hospital: lead

Study Sites (1)

Clinical Medical College of Yangzhou University

Yangzhou, Jiangsu, 225001, China

Location

MeSH Terms

Conditions

Fibrosis; Venous Thrombosis; Hypertension, Portal

Interventions

apixaban; Warfarin; Aspirin; aspirin, magnesium oxide combination; Dipyridamole; Heparin, Low-Molecular-Weight; Nadroparin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Pyrimidines; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Dou-Sheng Bai Bai, MD

  Clinical Medical College of Yangzhou University

  STUDY CHAIR

• Guo-Qing Jiang, MD

  Clinical Medical College of Yangzhou University

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: November 22, 2020
• First Posted: November 27, 2020
• Study Start: November 22, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)