[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613720":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":49,"centralContacts":50,"locations":59,"responsibleParty":85,"collaborators":49,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":89,"sex":95,"minAge":96,"maxAge":49,"enrollmentInfo":97,"targetDuration":49,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":112,"overallStatus":62,"whyStopped":49,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Medical University of Gdansk","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"APIXABAN (reduced dose)","EXPERIMENTAL","Participants receive apixaban 2.5 mg orally twice daily for at least 6 months.",[13],"Drug: Apixaban",{"label":15,"type":10,"description":16,"interventionNames":17},"RIVAROXABAN (reduced dose)","Participants receive rivaroxaban 10 mg orally once daily for at least 6 months.",[18],"Drug: Rivaroxaban",{"label":20,"type":21,"description":22,"interventionNames":23},"Low-Molecular-Weight Heparin (LMWH)","ACTIVE_COMPARATOR","Participants receive low-molecular-weight heparin, 40 mg subcutaneously once daily for at least 6 months.",[24],"Drug: low molecular weight heparin (enoxaparin sodium)",[26,34,42],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Apixaban","Oral tablet, 2.5 mg twice daily, for at least 6 months.",[9],[32,33],"Eliquis","Poltixa",{"type":27,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"Rivaroxaban","Oral tablet, 10 mg once daily, for at least 6 months.",[15],[39,40,41],"Xarelto","Mibrex","Zarixa",{"type":27,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"low molecular weight heparin (enoxaparin sodium)","Subcutaneous injection, 40 mg once daily (or equivalent), for at least 6 months.",[20],[47,48],"Clexane","Neoparin",null,[51,56],{"name":52,"role":53,"phone":54,"phoneExt":49,"email":55},"Agata Ogłoza-Puchowska, MD","CONTACT","+48 58 584 43 40","a.ogloza@gumed.edu.pl",{"name":57,"role":53,"phone":49,"phoneExt":49,"email":58},"Ewa Lewicka, Professor","ewa.lewicka@gumed.edu.pl",[60],{"facility":61,"status":62,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Department of Haematology & Transplantology","RECRUITING","Gdansk","Pomeranian Voivodeship","80-152","Poland","PL",{"type":69,"coordinates":70},"Point",[71,72],18.64912,54.35227,{"lat":72,"lon":71},[75,77,79,81,83],{"name":76,"role":53,"phone":54,"phoneExt":49,"email":55},"Agata Ogłoza-Puchowska, MD, Principle Investigator",{"name":57,"role":53,"phone":49,"phoneExt":49,"email":78},"e.lewicka@gumed.edu.pl",{"name":52,"role":80,"phone":49,"phoneExt":49,"email":49},"PRINCIPAL_INVESTIGATOR",{"name":57,"role":82,"phone":49,"phoneExt":49,"email":49},"SUB_INVESTIGATOR",{"name":84,"role":82,"phone":49,"phoneExt":49,"email":49},"Andrzej Mital, Professor",{"type":86,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR","100613720","reduced-dose-apixaban-and-rivaroxaban-versus-low-molecular-weight-heparin-in-patients-with-hematologic-malignancies-100613720",false,"NCT07270263","Reduced-Dose Apixaban and Rivaroxaban Versus Low-Molecular-Weight Heparin in Patients With Hematologic Malignancies","Efficacy and Safety of Reduced-Dose Apixaban and Rivaroxaban Versus Low-Molecular-Weight Heparin in Patients With Hematologic Malignancies: A Prospective Randomized Study","HEM-DOAC","Inclusion Criteria:\n\n* Active hematologic malignancy at the time of initiation of systemic therapy, including multiple myeloma, myeloproliferative neoplasm, lymphoma or other hematologic cancer with a Khorana score ≥ 2 points (intermediate or high risk of venous thromboembolism, VTE)\n* Use of anticoagulant agents for primary thromboprophylaxis, including direct oral anticoagulants (DOACs) at reduced doses (apixaban 2.5 mg twice daily or rivaroxaban 10 mg once daily) or low-molecular-weight heparin (LMWH) (enoxaparin 40 mg subcutaneously once daily).\n\nExclusion Criteria:\n\n* Major bleeding within the last month (including gastrointestinal or intracranial bleeding).\n* Active major bleeding.\n* Hemoglobin concentration \\\u003C 8 g\u002FdL.\n* Thrombocytopenia with platelet count \\\u003C30 × 10⁹\u002FL.\n* ECOG performance status of 3 or 4.\n* Expected survival \\\u003C6 months.\n* History of mechanical heart valve or severe mitral stenosis.\n* Estimated glomerular filtration rate (eGFR) \\\u003C 25 mL\u002Fmin.\n* Hepatic impairment (ALT ≥ 3× upper limit of normal or bilirubin ≥ 2× upper limit of normal).\n* Acute coronary syndrome or ischemic stroke within the last 6 months.\n* Anticipated significant drug-drug interactions between DOACs and anticancer agents.\n* Known antiphospholipid syndrome (APS).","ALL","18 Years",{"count":98,"type":99},100,"ESTIMATED","INTERVENTIONAL",[102],"NA","This study investigates the efficacy and safety of direct oral anticoagulants (DOACs) in comparison with standard low-molecular-weight heparin (LMWH) for the prevention of venous thromboembolism in patients with hematological malignancies. Eligible participants will be randomized to receive reduced-dose apixaban, reduced-dose rivaroxaban, or standard-dose LMWH. The primary objective is to evaluate the incidence of venous thromboembolism during a 6-month follow-up period. Secondary objectives include assessment of bleeding complications, overall survival, and treatment adherence. The results of this study may provide evidence for safer and more convenient thromboprophylaxis strategies in patients with blood cancers.",[105,106,107,108,109,110,111],"Lymphoma","Leukemia","Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma","Venous Thromboembolic Disease","VTE (Venous Thromboembolism)","PE - Pulmonary Embolism","Hematologic Malignacies",[28,35,113,114,115,116,117],"Low-Molecular-Weight Heparin","Venous Thromboembolism","Cancer-Associated Thrombosis","Hematologic Malignancies","Direct Oral Anticoagulants","2025-12-18",{"date":120,"type":121},"2025-12-26","ACTUAL",{"date":123,"type":121},"2024-11-22",{"date":125,"type":99},"2026-12-31",{"name":5,"class":6},1]