Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-03-08 @ 3:39 AM
Study NCT ID:
NCT04462003
Status:
UNKNOWN
Last Update Posted:
2020-07-08
First Post:
2020-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Apixaban in Malignancy With Deep Venous Thrombosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C522181', 'term': 'apixaban'}, {'id': 'D017984', 'term': 'Enoxaparin'}], 'ancestors': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Single blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-07-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-03', 'studyFirstSubmitDate': '2020-06-29', 'studyFirstSubmitQcDate': '2020-07-03', 'lastUpdatePostDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrent deep venous thrombosis or venous thromboembolism', 'timeFrame': '6 months', 'description': 'New or non resolving completely occluded deep venous thrombosis or occurrence of pulmonary embolism'}, {'measure': 'Occurrence of fatal or major bleeding', 'timeFrame': '6 months', 'description': 'Need for hospitalization, blood transfusion, surgical intervention or resulting into death'}, {'measure': 'Mortality related to massive pulmonary embolism', 'timeFrame': '6 months', 'description': 'Death caused by hemodynamic instability secondary to massive pulmonary embolism'}], 'secondaryOutcomes': [{'measure': 'Occurrence of non-fatal or minor bleeding', 'timeFrame': '6 months', 'description': 'Bleeding that does not need hospitalization, blood transfusion, surgical intervention or resulting into death'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Deep Vein Thrombosis', 'Malignancy']}, 'referencesModule': {'references': [{'pmid': '10737280', 'type': 'RESULT', 'citation': "Heit JA, Silverstein MD, Mohr DN, Petterson TM, O'Fallon WM, Melton LJ 3rd. Risk factors for deep vein thrombosis and pulmonary embolism: a population-based case-control study. Arch Intern Med. 2000 Mar 27;160(6):809-15. doi: 10.1001/archinte.160.6.809."}, {'pmid': '30918939', 'type': 'RESULT', 'citation': 'Ay C, Beyer-Westendorf J, Pabinger I. Treatment of cancer-associated venous thromboembolism in the age of direct oral anticoagulants. Ann Oncol. 2019 Jun 1;30(6):897-907. doi: 10.1093/annonc/mdz111.'}, {'pmid': '10963635', 'type': 'RESULT', 'citation': 'Hutten BA, Prins MH, Gent M, Ginsberg J, Tijssen JG, Buller HR. Incidence of recurrent thromboembolic and bleeding complications among patients with venous thromboembolism in relation to both malignancy and achieved international normalized ratio: a retrospective analysis. J Clin Oncol. 2000 Sep;18(17):3078-83. doi: 10.1200/JCO.2000.18.17.3078.'}, {'pmid': '12393647', 'type': 'RESULT', 'citation': 'Prandoni P, Lensing AW, Piccioli A, Bernardi E, Simioni P, Girolami B, Marchiori A, Sabbion P, Prins MH, Noventa F, Girolami A. Recurrent venous thromboembolism and bleeding complications during anticoagulant treatment in patients with cancer and venous thrombosis. Blood. 2002 Nov 15;100(10):3484-8. doi: 10.1182/blood-2002-01-0108. Epub 2002 Jul 12.'}, {'pmid': '26867832', 'type': 'RESULT', 'citation': 'Kearon C, Akl EA, Ornelas J, Blaivas A, Jimenez D, Bounameaux H, Huisman M, King CS, Morris TA, Sood N, Stevens SM, Vintch JRE, Wells P, Woller SC, Moores L. Antithrombotic Therapy for VTE Disease: CHEST Guideline and Expert Panel Report. Chest. 2016 Feb;149(2):315-352. doi: 10.1016/j.chest.2015.11.026. Epub 2016 Jan 7.'}, {'pmid': '31504429', 'type': 'RESULT', 'citation': 'Konstantinides SV, Meyer G, Becattini C, Bueno H, Geersing GJ, Harjola VP, Huisman MV, Humbert M, Jennings CS, Jimenez D, Kucher N, Lang IM, Lankeit M, Lorusso R, Mazzolai L, Meneveau N, Ni Ainle F, Prandoni P, Pruszczyk P, Righini M, Torbicki A, Van Belle E, Zamorano JL; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS). Eur Heart J. 2020 Jan 21;41(4):543-603. doi: 10.1093/eurheartj/ehz405. No abstract available.'}, {'pmid': '26407753', 'type': 'RESULT', 'citation': 'Agnelli G, Buller HR, Cohen A, Gallus AS, Lee TC, Pak R, Raskob GE, Weitz JI, Yamabe T. Oral apixaban for the treatment of venous thromboembolism in cancer patients: results from the AMPLIFY trial. J Thromb Haemost. 2015 Dec;13(12):2187-91. doi: 10.1111/jth.13153. Epub 2015 Oct 29.'}, {'pmid': '31630479', 'type': 'RESULT', 'citation': 'McBane RD 2nd, Wysokinski WE, Le-Rademacher JG, Zemla T, Ashrani A, Tafur A, Perepu U, Anderson D, Gundabolu K, Kuzma C, Perez Botero J, Leon Ferre RA, Henkin S, Lenz CJ, Houghton DE, Vishnu P, Loprinzi CL. Apixaban and dalteparin in active malignancy-associated venous thromboembolism: The ADAM VTE trial. J Thromb Haemost. 2020 Feb;18(2):411-421. doi: 10.1111/jth.14662. Epub 2019 Nov 28.'}, {'pmid': '30103252', 'type': 'RESULT', 'citation': 'Agnelli G, Becattini C, Bauersachs R, Brenner B, Campanini M, Cohen A, Connors JM, Fontanella A, Gussoni G, Huisman MV, Lambert C, Meyer G, Munoz A, Abreu de Sousa J, Torbicki A, Verso M, Vescovo G; Caravaggio Study Investigators. Apixaban versus Dalteparin for the Treatment of Acute Venous Thromboembolism in Patients with Cancer: The Caravaggio Study. Thromb Haemost. 2018 Sep;118(9):1668-1678. doi: 10.1055/s-0038-1668523. Epub 2018 Aug 13.'}, {'pmid': '28373761', 'type': 'RESULT', 'citation': 'Cheung KS, Leung WK. Gastrointestinal bleeding in patients on novel oral anticoagulants: Risk, prevention and management. World J Gastroenterol. 2017 Mar 21;23(11):1954-1963. doi: 10.3748/wjg.v23.i11.1954.'}, {'pmid': '23702623', 'type': 'RESULT', 'citation': 'Desai J, Kolb JM, Weitz JI, Aisenberg J. Gastrointestinal bleeding with the new oral anticoagulants--defining the issues and the management strategies. Thromb Haemost. 2013 Aug;110(2):205-12. doi: 10.1160/TH13-02-0150. Epub 2013 May 23. No abstract available.'}, {'pmid': '23725876', 'type': 'RESULT', 'citation': 'Desai J, Granger CB, Weitz JI, Aisenberg J. Novel oral anticoagulants in gastroenterology practice. Gastrointest Endosc. 2013 Aug;78(2):227-39. doi: 10.1016/j.gie.2013.04.179. Epub 2013 May 29. No abstract available.'}, {'pmid': '22898071', 'type': 'RESULT', 'citation': 'Cannon CP, Kohli P. Danger ahead: watch out for indirect comparisons! J Am Coll Cardiol. 2012 Aug 21;60(8):747-8. doi: 10.1016/j.jacc.2012.05.012. No abstract available.'}, {'pmid': '33153401', 'type': 'DERIVED', 'citation': 'Mokadem ME, Hassan A, Algaby AZ. Efficacy and safety of apixaban in patients with active malignancy and acute deep venous thrombosis. Vascular. 2021 Oct;29(5):745-750. doi: 10.1177/1708538120971148. Epub 2020 Nov 5.'}]}, 'descriptionModule': {'briefSummary': 'The aim of study was to evaluate the efficacy and safety of Apixaban in patients with acute deep venous thrombosis and active malignancy compared with weight adjusted subcutaneous (LMWH). It was hypothesised that Apixaban could be as effective as rivaroxiban and edoxaban in treatment of patients with acute DVT and active malignancy with a lower risk of bleeding especially in those with GIT cancer.', 'detailedDescription': 'Patients with active malignancy have hypercoagulable state particularly, those receiving intravenous chemotherapy, with six fold higher risk of venous thromboembolism (VTE) \\[1\\]. Anticoagulation for malignancy associated deep venous thrombosis (DVT) can be difficult because of different limitations like bleeding, drug-drug interactions with chemotherapy and inconvenience with repeated subcutaneous injections of low-molecular-weight heparin (LMWH) \\[2\\]. In comparison with patients without active malignancy, patients with cancer who are on warfarin therapy have 2 to 6 folds more major bleeding events and 2 to 3 times more VTE recurrence \\[3,4\\]. The American College of Chest Physicians Guidelines recommended (LMWH) as standard therapy for management of acute VTE in patients with active malignancy \\[5\\]. Recently, Rivaroxiban and Edoxaban were considered as an alternative to weight-adjusted subcutaneous LMWH after pulmonary embolism in patients with active cancer without gastrointestinal (GIT) malignancy \\[6\\]. Apixaban is a direct factor Xa inhibitor approved by FDA for treatment of DVT and VTE \\[7\\]. However its efficacy in management of acute DVT and VTE associated with cancer is still unresolved issue. The aim of study was to evaluate the efficacy and safety of Apixaban in patients with acute deep venous thrombosis and active malignancy compared with weight adjusted subcutaneous (LMWH).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria Patients with active malignancy presenting with acute deep venous thrombosis and still treated with chemotherapy\n\nExclusion Criteria:\n\n* Patients with pulmonary embolism and hemodynamic instability requiring thrombolytic therapy\n* Previous DVT or venous thromboembolism\n* Administration of LMWH or unfractionated heparin before randomization\n* Brain tumours, cerebral metastes, hepatic tumours or impairment Child-Pugh B or C, -Recent or current active or life threating bleeding (e.g. intr acranial haemorrhage or gastrointestinal bleeding)\n* Thrombocytopenia (platelets \\<100 x 109L)\n* Severe chronic kidney disease (estimated glomerular filtration rate \\<30 ml/minute)\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT04462003', 'acronym': 'DVT', 'briefTitle': 'Efficacy of Apixaban in Malignancy With Deep Venous Thrombosis', 'organization': {'class': 'OTHER', 'fullName': 'Beni-Suef University'}, 'officialTitle': 'Efficacy and Safety of Apixaban in Patients With Active Malignancy and Acute Deep Venous Thrombosis.', 'orgStudyIdInfo': {'id': 'Apixaban in DVT with cancer'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Apixaban', 'description': '50 patients with DVT with malignancy were randomized to apixaban 10 mg twice daily dose for 7 days followed by apixaban 5 mg twice daily', 'interventionNames': ['Drug: Apixaban']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enoxaparin', 'description': '50 patients with DVT with malignancy were randomized to enoxaparin (1mg/Kg/SC every 12 h)', 'interventionNames': ['Drug: Enoxaparin']}], 'interventions': [{'name': 'Apixaban', 'type': 'DRUG', 'description': '10 mg/12 h for 1 week followed by 5 mg/12 h', 'armGroupLabels': ['Apixaban']}, {'name': 'Enoxaparin', 'type': 'DRUG', 'description': '1mg/Kg/sc/12h', 'armGroupLabels': ['Enoxaparin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62511', 'city': 'Banī Suwayf', 'state': 'Beni Suweif Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mostafa O Mokadem', 'role': 'CONTACT', 'email': 'mostafa.elmokadem9@gmail.com', 'phone': '00201009414408'}, {'role': 'CONTACT', 'email': 'mostafa.elmokadem9@gmail.com', 'phoneExt': 'Mokadem'}, {'name': 'Mostafa O Mokadem', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Abd el aziz Z Algaby', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ahmed H Shaaban', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Faculty of Medicine,Beni-Suef University', 'geoPoint': {'lat': 29.07441, 'lon': 31.09785}}], 'centralContacts': [{'name': 'Mostafa O Mokadem', 'role': 'CONTACT', 'email': 'mostafa.elmokadem9@gmail.com', 'phone': '00201009414408'}, {'name': 'Abd el aziz Z Algaby', 'role': 'CONTACT', 'email': 'zizogaby@hotmail.com', 'phone': '00201227563870'}], 'overallOfficials': [{'name': 'Mostafa E Mokadem', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine, Beni-Suef University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beni-Suef University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Mostafa El Mokadem', 'investigatorAffiliation': 'Beni-Suef University'}}}}