Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:48 PM
Study NCT ID:
NCT07461532
Status:
RECRUITING
Last Update Posted:
2026-03-25
First Post:
2026-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Apixaban in Treating Portal Vein Thrombosis Occurring More Than One Year After LSD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D006975', 'term': 'Hypertension, Portal'}, {'id': 'D006971', 'term': 'Hypersplenism'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D013158', 'term': 'Splenic Diseases'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C522181', 'term': 'apixaban'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-21', 'studyFirstSubmitDate': '2026-03-04', 'studyFirstSubmitQcDate': '2026-03-04', 'lastUpdatePostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of participants with Main and Intrahepatic Branches of Portal Vein Thrombosis', 'timeFrame': 'Follow-up of 12 months or greater', 'description': 'Proportion of participants with thrombosis involving the main portal vein and intrahepatic branches, as determined by Doppler ultrasound imaging.'}, {'measure': 'Complete resolution of portal vein thrombosis as assessed by Doppler ultrasound after re-anticoagulation', 'timeFrame': 'Follow-up of 12 months or greater', 'description': 'Complete resolution of portal vein thrombosis in patients with PVT detected at one-year follow-up post-discontinuation, as confirmed by Doppler ultrasound after re-anticoagulation.'}], 'secondaryOutcomes': [{'measure': 'Proportion of participants with splenic vein thrombosis as assessed by Doppler ultrasound', 'timeFrame': '12 months', 'description': 'Proportion of participants with splenic vein thrombosis as determined by Doppler ultrasound imaging.'}, {'measure': 'Proportion of participants with mesenteric vein thrombosis as assessed by Doppler ultrasound', 'timeFrame': '12 months', 'description': 'Proportion of participants with mesenteric vein thrombosis as determined by Doppler ultrasound imaging.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cirrhosis', 'Venous thrombosis', 'Portal Hypertension', 'Apixaban', 'Splenectomy', 'Laparoscopy', 'Hypersplenism'], 'conditions': ['Cirrhosis', 'Splenectomy', 'Venous Thrombosis', 'Hypertension, Portal']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Apixaban is effective and safe in the treatment of portal vein thrombosis at one year and long-term follow-up in liver cirrhotic patients after laparoscopic splenectomy and azygoportal disconnection.', 'detailedDescription': 'After successful screening, liver cirrhotic patients of any etiology without portal vein thrombosis will be enrolled. From postoperative day 1, patients in the apixaban group will receive oral apixaban 2.5 mg twice daily for six months as monotherapy. Doppler ultrasound screening for portal vein thrombosis (PVT) or spleno-mesenteric thrombosis will be performed for all patients at baseline, on postoperative day 7 (POD 7), and at postoperative months 1, 3, 6, 12, 18, 24, and 36 (POM 1, 3, 6, 12, 18, 24, 36). All patients will complete the six-month prophylactic therapy regardless of Doppler findings regarding PVT occurrence. After the six-month treatment period, patients will be evaluated and will discontinue therapy to enter the monitoring phase. Long-term follow-up will continue up to 36 months to evaluate the primary outcome of PVT treatment effect and secondary outcomes including portal hypertension progression, rebleeding rates, hepatic encephalopathy, and survival.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. A clinical, radiological, or histologic diagnosis of cirrhosis of any etiology.\n2. Splenomegaly with secondary hypersplenism.\n3. Bleeding portal hypertension.\n4. No evidence of portal vein thrombosis (PVT) or spleno-mesenteric thrombosis by ultrasound evaluation and angio-CT prior to surgery.\n5. Underwent laparoscopic splenectomy and azygoportal disconnection (LSD) at our center.\n6. Received routine aspirin anticoagulation (2.5 mg twice daily) immediately after surgery.\n7. Had no imaging evidence (Doppler ultrasound or CT) of PVT during postoperative months 6 to 12.\n8. Developed de novo PVT after 12 months post-surgery.\n9. Provided informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Hepatocellular carcinoma or any other malignancy,\n2. Hypercoagulable state other than the liver disease related\n3. DRUGS- oral contraceptives, anticoagulation or anti-platelet drugs.\n4. Child - Pugh C\n5. Recent peptic ulcer disease\n6. History of Hemorrhagic stroke\n7. Pregnancy.\n8. Uncontrolled Hypertension\n9. Human immunodeficiency virus (HIV) infection'}, 'identificationModule': {'nctId': 'NCT07461532', 'briefTitle': 'Efficacy of Apixaban in Treating Portal Vein Thrombosis Occurring More Than One Year After LSD', 'organization': {'class': 'OTHER', 'fullName': "Northern Jiangsu People's Hospital"}, 'officialTitle': 'Efficacy of Apixaban in Treating Portal Vein Thrombosis Occurring More Than One Year After Laparoscopic Splenectomy and Azygoportal Disconnection', 'orgStudyIdInfo': {'id': 'YZUC-016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Apixaban group', 'description': 'From postoperative day 1, patients will receive oral apixaban tablets (Bristol-Myers Squibb, Cruiserath, USA) 2.5 mg twice daily until month 6. Doppler ultrasound screening will be performed to assess the occurrence of portal vein thrombus.', 'interventionNames': ['Drug: Apixaban 2.5 MG']}], 'interventions': [{'name': 'Apixaban 2.5 MG', 'type': 'DRUG', 'description': 'From postoperative day 1, patients will receive oral apixaban tablets (Bristol-Myers Squibb, Cruiserath, USA) 2.5 mg twice daily until month 6. Doppler ultrasound screening will be performed to assess the occurrence of portal vein thrombus.', 'armGroupLabels': ['Apixaban group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '225001', 'city': 'Yangzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guo-Qing Jiang, MD', 'role': 'CONTACT', 'email': 'jgqing2003@hotmail.com', 'phone': '+8651487373382'}, {'name': 'Dou-Sheng Bai, MD', 'role': 'CONTACT', 'email': 'bdsno1@hotmail.com'}], 'facility': 'Clinical Medical College', 'geoPoint': {'lat': 32.39722, 'lon': 119.43583}}], 'centralContacts': [{'name': 'Guo-Qing Jiang, MD', 'role': 'CONTACT', 'email': 'jgqing2003@hotmail.com', 'phone': '+8651487373272'}, {'name': 'Dou-Sheng Bai, MD', 'role': 'CONTACT', 'email': 'bdsno1@hotmail.com', 'phone': '+8651487373275'}], 'overallOfficials': [{'name': 'Dou-Sheng Bai', 'role': 'STUDY_CHAIR', 'affiliation': 'Clinical Medical College, Yangzhou University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Northern Jiangsu People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Guo-Qing Jiang', 'investigatorAffiliation': "Northern Jiangsu People's Hospital"}}}}