[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"anticoagulant-induced-bleeding\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:anticoagulant-induced-bleeding":34},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,51,76,104],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":36,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100382700","phase-4-clinical-surveillance-vs-anticoagulation-for-low-risk-patients-with-isolated-subsegmental-pulmonary-embolism-100382700",false,"NCT04263038","Clinical Surveillance vs. Anticoagulation for Low-risk Patients With Isolated Subsegmental Pulmonary Embolism","Clinical Surveillance vs. Anticoagulation for Low-risk Patients With Isolated Subsegmental Pulmonary Embolism: a Multicenter Randomized Placebo-controlled Non-inferiority Trial","SAFE-SSPE","Inclusion Criteria:\n\n1. Informed Consent as documented by signature\n2. Age ≥18 years\n3. Objective diagnosis of symptomatic or asymptomatic isolated SSPE\n\nExclusion Criteria:\n\n1. Presence of leg deep vein thrombosis (DVT) or upper extremity DVT (subclavian vein or above)\n2. Active cancer, defined as cancer treated with surgery, chemotherapy, radiotherapy, or palliative care during the last 6 months\n3. ≥1 prior episode of unprovoked VTE (absence of a transient or permanent risk factor)\n4. Clinical instability (systolic blood pressure \\\u003C100 mm Hg or arterial Oxygen saturation \\\u003C92% at ambient air) at the time of presentation\n5. Active bleeding or at high risk of bleeding\n6. Severe renal failure (creatinine clearance \\\u003C30ml\u002Fmin)\n7. Severe liver insufficiency (Child-Pugh B or C)\n8. Concomitant use of strong CYP3A4 inhibitors or strong CYP3A4 inducers\n9. Known hypersensitivity to rivaroxaban\n10. Need for therapeutic anticoagulation for another reason\n11. Therapeutic anticoagulation for \\>72 hours for any reason at the time of screening\n12. Hospitalized for \\>72 hours prior to the diagnosis of isolated SSP (hospital-acquired VTE)\n13. Known pregnancy or breast feeding (pregnancy test to be performed for women of childbearing potential)\n14. Lack of safe contraception in women of childbearing potential\n15. Refusal or inability to provide informed consent\n16. Prior enrolment in this trial","ALL","18 Years",{"count":20,"type":21},276,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","The clinical significance of pulmonary embolism (PE) limited to the subsegmental pulmonary arteries, so called isolated subsegmental pulmonary embolism (SSPE), remains controversial. Whether isolated SSPE represents \"true\" PE, a clinically more benign form of PE, a physiologic lung clearing process, or a false positive result (artifact) is currently unclear and hence, whether patients with isolated SSPE benefit from anticoagulant treatment is uncertain. Despite growing evidence from observational studies that withholding anticoagulation may be a safe option in selected patients with isolated SSPE (i.e., those without concomitant deep vein thrombosis, cancer, etc.), most patients with isolated SSPE receive anticoagulant treatment, which is associated with an increased risk of bleeding. The overall objective of the randomized controlled SAFE-SSPE trial is to evaluate the efficacy and safety of clinical surveillance without anticoagulation compared to anticoagulation treatment in low-risk patients with isolated SSPE.",[27,28,29,30,31,32,33,34,35],"Pulmonary Embolism","Embolism","Embolism and Thrombosis","Lung Diseases","Cardiovascular Diseases","Respiratory Tract Diseases","Venous Thromboembolism","Anticoagulant-induced Bleeding","Bleeding",[37],"subsegmental pulmonary embolism","RECRUITING","2026-05-20",{"date":41,"type":42},"2026-05-22","ACTUAL",{"date":44,"type":42},"2020-05-15",{"date":46,"type":21},"2028-05",{"name":48,"class":49},"Drahomir Aujesky","OTHER",40,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100461607","anticoagulation-after-gi-bleeding-pilot-study-and-registry-100461607","NCT05290857","Anticoagulation After GI Bleeding Pilot Study and Registry","Post-Bleed Management of Antithrombotic Therapy After Gastrointestinal Bleeding: Pilot Study and Registry (PANTHER-GI)","PANTHER-GI","Inclusion Criteria:\n\n1. Male or female subjects aged 18 years or older\n2. Hospitalized with acute major non-variceal GI bleeding (defined as per ISTH criteria) while receiving OAC therapy (warfarin or DOAC).\n3. OAC therapy discontinued for current acute GI bleed and not yet resumed\n4. Ongoing indication for long-term anticoagulation of atrial fibrillation (moderate to high risk of stroke\u002Fsystemic embolism with CHA2DS2VASc score of 3 or higher) or VTE (as per clinical care team)\n5. Planned to resume DOAC post-bleed\n6. At moderate to high risk of re-bleeding as per clinical care team\n7. Clinical hemostasis achieved as per clinical care team\n8. Able and willing to comply with follow-up examinations contained within the consent form\n\nExclusion Criteria:\n\n1. Mechanical heart valve\n2. VTE in the context of major transient risk factor and completed 3 months of treatment\n3. GI bleeding managed surgically (e.g. gastrectomy, colectomy)\n4. Active or previously treated gastrointestinal cancer\n5. Life expectancy from other causes of less than 3 months\n6. Platelet count \\\u003C 50,000\u002FµL (or \\\u003C 50x109\u002FL)\n7. Renal dysfunction (Creatine Clearance \\\u003C30 mL\u002Fmin as calculated by the Cockcroft-Gault formula)",{"count":60,"type":21},100,[62],"NA","PANTHER-GI Pilot Study will assess the feasibility of a full-scale multicentre cohort management study evaluating the safety of a standardized strategy for resuming direct oral anticoagulants (DOACs) after major DOAC-related gastrointestinal (GI) bleeding among patients at moderate to high risk of re-bleeding and thrombosis. A parallel registry will assess whether eligible patients who are not enrolled in the PANTHER-GI Pilot Study are systematically different than enrolled patients and to explore barriers to enrolment.",[65,34],"GastroIntestinal Bleeding","2025-07-28",{"date":68,"type":42},"2025-07-30",{"date":70,"type":42},"2022-03-31",{"date":72,"type":21},"2025-12",{"name":74,"class":49},"Ottawa Hospital Research Institute",2,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":103},"100584279","peri-procedural-management-of-direct-oral-anticoagulants-for-central-venous-catheters-in-cancer-patients-with-venous-thromboembolism-or-atrial-fibrillation-pilot-study-100584279","NCT06887270","Peri-procedural Management of Direct Oral Anticoagulants for Central VENOus Catheters in CAncer Patients With Venous Thromboembolism or Atrial Fibrillation Pilot Study","Peri-procedural Management of Direct Oral Anticoagulants for Central VENOus Catheters in CAncer Patients With Venous Thromboembolism or Atrial Fibrillation (VENOCAT) Pilot Study","VENO CAT","Inclusion Criteria:\n\n1. Adult patients with VTE or non-valvular AF on prophylactic or therapeutic dose DOAC\n2. Active cancer, defined as diagnosed within the past 6 months; or recurrent, regionally advanced, or metastatic cancer; or for which treatment had been administered within 6 months of port or tunneled CVC insertion; or hematologic cancer not in complete remission\n3. Pending elective radiologically guided insertion of tunneled or port CVC\n4. Able and willing to adhere to peri-procedural DOAC management plan and follow-up\n\nExclusion Criteria:\n\n1. Creatinine clearance (Cockcroft-Gault equation) \\\u003C30 mL\u002Fmin for Dabigatran, Rivaroxaban, or Edoxaban, and \\\u003C25mL\u002Fmin for Apixaban\n2. Diagnosis of VTE within 21 days\n3. Platelet count \\\u003C 50 x 10\\^9\u002FL at time of study entry\n4. Concomitant strong inhibitors or inducers to P-glycoprotein and\u002For CYP-3A4",{"count":85,"type":21},10,[62],"The peri-procedural management of direct oral anticoagulants (DOACs) in persons with cancer (PWC) undergoing tunneled or port central venous catheter (CVC) insertion is a common but understudied clinical problem, with conflicting management advice from guidelines and resultant uncertainty for best practices. Data from prospective studies assessing peri-procedural DOAC management exist; however, these data pertain to procedures in the general population. These management strategies may not be applicable to PWC because (1) although CVC insertion is a low risk, image-guided specialized procedure, (2) PWC are at considerably higher risk of peri-procedural bleeding and thrombosis than non-PWC. It is not surprising, therefore, that guideline recommendations and current practices vary widely. To resolve management uncertainty and establish a standard-of-care, the VENOCAT pilot randomized controlled trial (RCT) is a first step that will assess the feasibility of a definitive trial comparing continued vs. interrupted DOAC management in PWC undergoing tunneled or port CVC insertion. Evidence is needed to standardize clinical practice and reduce the risk of bleeding and thrombotic complications.",[34,89,90,91,92],"Direct Oral Anticoagulant","Cancer","Central Venous Catheter","Periprocedural Complication","NOT_YET_RECRUITING","2025-03-13",{"date":96,"type":42},"2025-03-20",{"date":98,"type":21},"2025-09",{"date":100,"type":21},"2027-09",{"name":102,"class":49},"University Health Network, Toronto",1,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":111,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":114,"phases":4,"briefSummary":115,"conditions":116,"keywords":117,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":103},"100531040","rivaroxaban-in-elderly-chinese-venous-thromboembolism-patients-100531040","NCT06194617","Rivaroxaban in Elderly Chinese Venous Thromboembolism Patients","The Exploratory Study on Clinical Rational Use of Rivaroxaban Dosing in Elderly Chinese Population","Inclusion Criteria:\n\n* (1) Adult patients with objectively diagnosed acute symptomatic pulmonary embolism (with or without concurrent deep vein thrombosis) by imaging, who have completed acute anticoagulation and entered the anticoagulation maintenance phase; (2) Life expectancy greater than 3 months; (3) Meeting the indications for Xa factor inhibitor use; (4) Willingness to participate in this study, sign the informed consent form, and adhere to regular follow-ups.\n\nExclusion Criteria:\n\n* (1) Moderate or severe hepatic impairment (Child-Pugh Class B or C); (2) Severe renal impairment (CrCl \\\u003C 15ml\u002Fmin); (3) Pregnant or breastfeeding women; (4) Spontaneous bleeding tendencies, such as coagulation disorders or low platelet count (PLT \\\u003C 20×10\\^9\u002FL); (5) Contraindications to other Xa factor inhibitors' usage; (6) Patients diagnosed with hereditary thrombophilia and antiphospholipid syndrome.",true,{"count":113,"type":21},300,"OBSERVATIONAL","There's no unified recommendation in clinical practice regarding adjusting dosages for different patient types, especially when adverse events occur. While rivaroxaban typically doesn't require coagulation monitoring, in elderly patients, particularly those with multiple medications, finding appropriate lab indicators becomes crucial to gauge its anticoagulant effect. This aids in evaluating precise rivaroxaban dosing for the elderly, balancing bleeding risks and recurrence. Clinical pharmacological studies suggest that drug pharmacokinetics and pharmacodynamics in different populations can guide dosage optimization. Hence, this study aims to provide a basis for optimizing dosing regimens in high-risk elderly patients in China by exploring pharmacokinetic and pharmacodynamic indicators in clinical practice.",[27,33,34],[27,33,118],"Direct Oral Anticoagulants","2023-12-22",{"date":121,"type":42},"2024-01-08",{"date":123,"type":42},"2021-04-01",{"date":125,"type":21},"2026-09-30",{"name":127,"class":49},"Peking Union Medical College Hospital"]