[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"major-bleed\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:major-bleed":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,78],{"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":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100351976","phase-4-the-danish-warfarin-dialysis-study---safety-and-efficacy-of-warfarin-in-patients-with-atrial-fibrillation-on-dialysis-100351976",false,"NCT03862859","The Danish Warfarin-Dialysis Study - Safety and Efficacy of Warfarin in Patients With Atrial Fibrillation on Dialysis","The Danish Warfarin-Dialysis Study: Safety and Efficacy of Warfarin in Patients With Atrial Fibrillation on Dialysis - A Nationwide Parallel-group Open Randomized Clinical Trial","DANWARD","Inclusion Criteria:\n\n* Patients ≥18 years on chronic dialysis due to end-stage renal disease\n* Non-valvular paroxysmal, persistent, or permanent atrial fibrillation OR non-treated (for \\>2 months) prevalent paroxysmal, persistent or permanent atrial fibrillation as documented by an electrocardiogram or an episode of ≥30 seconds on Holter monitor, or episodes ≥ 6 minutes on event recorders or any other recording device.\n* Competence to understand the study rationale, including potential risks and benefits associated with treatment, necessary for written informed consent.\n\nExclusion Criteria:\n\n* CHA2DS2-VASc Score ≤1\n* Other indications for oral anticoagulation treatment (pulmonary embolism \\\u003C 6 months, deep vein thrombosis \\\u003C3 months, mechanical heart valve prosthesis) irrespective of whether treatment is implemented\n* Ongoing dual antiplatelet treatment\n* Malignancy (with exception of non-melanoma skin cancer) with recent \\\u003C 1 year, ongoing, or planned curative, or palliative chemo- , radiation-, and\u002For scheduled surgical therapy\n* Endoscopy with gastrointestinal ulcer \\\u003C1 month\n* Esophageal varices\n* Autoimmune og genetic coagulation disorders\n* Congenital alactasia, Lapp Lactase deficiency or glucose-galactose malabsorption\n* Pending spinal tap\n* Cerebrovascular malformations\n* Arterial aneurysms\n* Ulcers or wounds (Wagner grad \\>1)\n* Bacterial endocarditis \\\u003C 3 months\n* Active bleeding contraindicating anticoagulation\n* Any non-elective and\u002For non-ambulant surgery \\\u003C7 days\n* Cerebral hemorrhage \\\u003C4 weeks\n* Thrombocytopenia (platelet count \\\u003C100 × 109\u002FL) \\\u003C30 days.\n* Severe liver insufficiency (spontaneous international normalized ratio \\>1.5) \\\u003C30 days.\n* Known intolerance to warfarin\n* Use of hypericum perforatum \u002F St. John's Wort\n* Uncontrolled hypertension (repeat blood pressure \\>180\u002F110 mmhg) \\\u003C 30 days\n* Uncontrolled hyperthyroidism (thyroid-stimulating hormone \\\u003C0.1μIU\u002FmL) \\\u003C30 days\n* Pregnancy or lactation\n* Participation in other ongoing intervention trials adjudged to influence study outcomes","ALL","18 Years",{"count":20,"type":21},718,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","The study aims to evaluate the appropriateness of initiating oral anticoagulation for stroke risk reduction in dialysis populations with atrial fibrillation. Specifically, the study will assess the overall safety, tolerability, and efficacy of initiating treatment with Warfarin in patients with end-stage renal disease on dialysis and atrial fibrillation.",[27,28,29,30],"Atrial Fibrillation and Flutter","Stroke","Major Bleed","End-stage Renal Disease","RECRUITING","2026-05-17",{"date":34,"type":35},"2026-05-19","ACTUAL",{"date":37,"type":35},"2019-10-09",{"date":39,"type":21},"2027-01",{"name":41,"class":42},"Nicholas Carlson","OTHER",13,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":63,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100515753","phase-4-comparison-of-clopidogrel-based-antiplatelet-therapy-versus-warfarin-as-secondary-prevention-strategy-for-antiphospholipid-syndrome-related-stroke-100515753","NCT05995600","Comparison of Clopidogrel-based Antiplatelet Therapy Versus Warfarin As Secondary Prevention Strategy for AntiPhospholipid Syndrome-related STROKE","Comparison of Clopidogrel-based Antiplatelet Therapy Versus Warfarin As Secondary Prevention Strategy for AntiPhospholipid Syndrome-related STROKE (APS-STROKE)","APS-STROKE","Inclusion Criteria:\n\n* Age 19 years or older\n* History of ischemic stroke (cerebral infarction, transient ischemic attack, or retinal arterial ischemic event)\n* Patients who meet the laboratory diagnostic criteria for antiphospholipid syndrome (APS)\n* Patients or guardians who agree to the study protocol and sign with informed consent\n\nExclusion Criteria:\n\n* Patients with high-risk antiphospholipid antibody profile (triple positivity; persistent high-titers exceeding 80 U\u002FmL of anti-cardiolipin or anti-β2 glycoprotein I antibodies)\n* Systemic lupus erythematous\n* Patients unable to discontinue previously taken anticoagulants or antiplatelet agents (e.g., atrial fibrillation, valvular heart disease, or a history of percutaneous coronary intervention)\n* Women who are pregnant, breastfeeding, or intending to become pregnant during the study period\n* Deemed unsuitable for participation in the study for more than four years, as per the investigators' discretion","19 Years",{"count":54,"type":21},200,[24],"Antiphospholipid syndrome (APS) has a close association with ischemic stroke; however, the optimal treatment strategy for APS-related stroke has yet to be established. The clinical guidelines suggest using warfarin for APS-related stroke, but these suggestions are largely based on retrospective studies from the 1990s and expert opinion, rather than high-quality clinical trials. Moreover, the evidence on the role of antiplatelet drugs other than aspirin (e.g., clopidogrel) in APS-related stroke is particularly limited. Considering the relatively young age of patients with APS and the high clinical burden of using warfarin, it is necessary to verify whether warfarin is essential. Thus, the investigators aim to compare clopidogrel-based antiplatelet therapy and warfarin as a secondary preventive medication for patients with APS-related stroke. APS-STROKE is an exploratory, multicenter, prospective, randomized, open, blinded-endpoint clinical trial. Adult patients with definite APS who have a history of ischemic stroke will be included. Patients with high-risk APS (triple positivity or persistently high titers of anti-cardiolipin or anti-β2-glycoprotein I antibodies), systemic lupus erythematous, or indications for continued antiplatelet or anticoagulant therapy will be excluded. Eligible patients will be 1:1 randomized to receive clopidogrel-based antiplatelet therapy or warfarin. Patients assigned to the clopidogrel-based antiplatelet therapy group will be permitted to use additional antiplatelet drugs other than clopidogrel at the investigator's discretion. The primary outcome is a composite of any death, major adverse cardiovascular events, systemic thromboembolic events, and major bleeding during a follow-up period of at least 4 years. This study would provide valuable information for determining the optimal secondary prevention strategy for APS-related stroke.",[58,59,60,61,62,29],"Antiphospholipid Syndrome","Ischemic Stroke","Transient Ischemic Attack","Cerebrovascular Disease","Cardiovascular Diseases",[64,65,66,67],"Antiphospholipid syndrome","Ischemic stroke","Secondary prevention","Thrombosis","2024-10-13",{"date":70,"type":35},"2024-10-16",{"date":72,"type":35},"2024-02-20",{"date":74,"type":21},"2029-03",{"name":76,"class":42},"Seoul National University Hospital",32,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":89,"conditions":90,"keywords":98,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":115},"100491430","phase-3-stroke-prophylaxis-with-apixaban-in-chronic-kidney-disease-stage-5-patients-with-atrial-fibrillation-100491430","NCT05679024","Stroke Prophylaxis With Apixaban in Chronic Kidney Disease Stage 5 Patients With Atrial Fibrillation","SACK","Inclusion Criteria:\n\n1. Signed Written Informed Consent\n2. 18 years of age or older\n3. Ongoing treatment with any chronic dialysis treatment OR an estimated glomerular filtration rate (eGFR)\\* \\\u003C20 ml\u002Fmin\u002F1.73 m2 at least twice 3 months apart of which at least one occasion is \\\u003C15 ml\u002Fmin\u002F1.73 m2 due to CKD during the last year (12 months).\n4. Diagnosis of chronic (i.e., repeated) paroxysmal, persistent, or permanent atrial fibrillation (AF) or atrial flutter (AFL)\n5. CHA2DS2-VASc score ≥2 or more for men ≥3 or more for women as an indication for oral anticoagulation\n6. Women of childbearing potential (WOCBP) should have a negative highly effective pregnancy test at screening and must agree to follow instructions for method(s) of contraception for the duration of treatment\n\nExclusion Criteria:\n\nParticipants may not be included in the study if any of the following criteria are met:\n\n1. AF or AFL due to reversible causes (e.g., thyrotoxicosis, pericarditis)\n2. Any degree of rheumatic mitral stenosis or moderate-to-severe non-rheumatic mitral stenosis at the time of inclusion into the study\n3. Any condition other than AF or AFL that requires chronic anticoagulation (e.g., a prosthetic mechanical heart valve, antiphospholipid syndrome).\n4. Any contraindication for anticoagulation including\n\n   1. endocarditis\n   2. documented intolerance for apixaban\n   3. liver disease with documented coagulation disorder\n   4. pregnancy or breast feeding\n5. Active bleeding or serious bleeding within 3 months, or\n\n   1. documented hemorrhagic blood dyscrasia\n   2. patients currently receiving dual antiplatelet therapy\n6. Planned for surgery\n\n   1. kidney transplantation with a living donor within 3 months\n   2. active on the kidney transplant waiting list at a kidney transplant center where apixaban use is prohibited\n   3. valvular heart disease surgery\n7. Current use of strong inhibitors of both CYP3A4 and P-glycoprotein in accordance with the summary of product characteristics (SmPC) of apixaban or regular intake of non-steroidal anti-inflammatory drugs (NSAID) or cyclooxygenase-2 (COX2) inhibitors\n8. Any condition or circumstance in which the patient should not participate in the study according to the study investigator (reason documented in the pre-screening protocol)\n\nBeing active on the kidney transplant waiting list is not an exclusion criterion if it is allowed according to the current clinical guidelines at the transplant clinic where the patient is registered. The patient must report changes in waiting list status to the investigator promptly.",{"count":86,"type":21},1400,[88],"PHASE3","Objective: To study the efficacy and safety of apixaban as stroke prophylaxis in patients with chronic kidney disease (CKD) stage 5 and atrial fibrillation (AF) with or without dialysis treatment. The study hypothesis is that compared to no anticoagulation, apixaban reduces the incidence of ischemic stroke without causing an unacceptable increase in fatal or intracranial bleeding events.\n\nThe secondary objectives are to evaluate the risk of all-cause mortality, cardiovascular events, and major bleeding in people with CKD stage 5 and AF treated with apixaban compared to standard of care without anticoagulation.\n\nTrial design: Pragmatic Prospective Open Label Randomized Controlled Clinical Trial, phase 3b over 12-72 months.\n\nTrial population: 1000-1400 patients at ≈50 sites in Sweden, Finland, Norway, Iceland and Poland Eligibility criteria: Adults ≥18 years with CKD stage 5 (ongoing treatment with any chronic dialysis treatment OR an estimated glomerular filtration rate (eGFR)\\* \\\u003C20 ml\u002Fmin\u002F1.73 m2 at least twice 3 months apart of which at least one occasion is \\\u003C15 ml\u002Fmin\u002F1.73 m2 due to CKD during the last 12 months) and a diagnosis of chronic, paroxysmal, persistent, or permanent AF or atrial flutter (AFL) with CHA2DS2-VASc score ≥2 for men or ≥3 or more for women as an indication for oral anticoagulation.\n\nThe exclusion criteria are AF or AFL due to reversible causes, rheumatic mitral stenosis or moderate-to-severe non-rheumatic mitral stenosis at the time of inclusion into the study, a condition other than AF or AFL that requires chronic anticoagulation, contraindications for anticoagulation, active bleeding or serious bleeding within 3 months, planned for surgery within 3 months, and current use of strong inhibitors of both CYP3A4 and P-glycoprotein.\n\nInterventions: Randomization 1:1 to treatment with apixaban 2.5 mg twice daily and standard of care, or standard of care and no anticoagulation.\n\nOutcome measures: primary efficacy (time to first ischemic stroke); primary safety (the composite of time to first intracranial bleeding or fatal bleeding); secondary efficacy (time to all-cause mortality, time to cardiovascular event or cardiovascular death); secondary safety (time to first major bleeding according to International Society on Thrombosis and Hemostasis (ISTH) criteria)",[91,92,28,93,29,94,95,96,97],"Chronic Kidney Diseases","Atrial Fibrillation","Intracerebral Hemorrhage","Cardiovascular Complication","Death","Kidney Transplant; Complications","Thromboses, Venous",[99,100,101,102,103,104],"Chronic kidney disease","Hemodialysis","Peritoneal dialysis","Kidney transplantation","Atrial fibrillation","Oral anticoagulation","2024-10-02",{"date":107,"type":35},"2024-10-04",{"date":109,"type":35},"2023-02-17",{"date":111,"type":21},"2028-12-31",{"name":113,"class":114},"Region Stockholm","OTHER_GOV",34]