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

NCT ID: NCT04645550

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-22
• Study Completion Date: 2023-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Apixaban

Intervention Type: DRUG

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

Dipyridamole

Intervention Type: DRUG

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

Low molecular weight heparin

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Warfarin

Intervention Type: 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.

Dipyridamole

Intervention Type: DRUG

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

Low molecular weight heparin

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Aspirin

Intervention Type: DRUG

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

Dipyridamole

Intervention Type: DRUG

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

Low molecular weight heparin

Intervention Type: DRUG

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

Interventions

Apixaban

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

Intervention Type: 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.

Intervention Type: DRUG

Aspirin

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

Intervention Type: DRUG

Dipyridamole

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

ELIQUIS; Warfarin Sodium; Athrombine; COUMADIN; PANAWARFIN; Acenterine; Acetard; Acetophen; Gardoxin; Coribon; Curantyl; Dilaplus; Fraxiparine

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northern Jiangsu People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Guo-Qing Jiang

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dou-Sheng Bai Bai, MD

Role: STUDY_CHAIR

Clinical Medical College of Yangzhou University

Guo-Qing Jiang, MD

Role: STUDY_DIRECTOR

Clinical Medical College of Yangzhou University

Sheng-Jie Jin, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Medical College of Yangzhou University

Bao-Huan Zhou, MS

Role: PRINCIPAL_INVESTIGATOR

Clinical Medical College of Yangzhou University

Tian-Ming Gao, MS

Role: PRINCIPAL_INVESTIGATOR

Clinical Medical College of Yangzhou University

Locations

Clinical Medical College of Yangzhou University

Yangzhou, Jiangsu, China

Countries

China

Other Identifiers

YZUC-005

Identifier Type: -

Identifier Source: org_study_id