[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bleeding-post-mechanical-valve-replacement\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bleeding-post-mechanical-valve-replacement":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100334586","phase-3-low-inr-to-minimize-bleeding-with-mechanical-valves-trial-100334586",false,"NCT03636295","Low INR to Minimize Bleeding With Mechanical Valves Trial","LIMIT","Inclusion criteria:\n\n* Age is 18 or older at the time of enrolment\n* Have had a bileaflet mechanical heart valve implant in the aortic position 3 or more months ago\n* Written informed consent from either the patient or substitute decision maker\n\nExclusion criteria:\n\n* Has a second implanted mechanical valve (any position)\n* Lower boundary of planned INR range is less than 2.0\n* Pregnant or expecting to become pregnant during the study follow-up","ALL","18 Years",{"count":19,"type":20},2625,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This study evaluates the use of a lower INR target (1.5 to 2.5) in patients with a mechanical bileaflet heart valve in the aortic position. This study will inform physicians about whether a lower INR target will decrease the risk of bleeding or increase the risk of blood clot formation and stroke. These results have the potential to reduce the burden of bleeding in patients with a mechanical heart valve who require lifelong warfarin (Coumadin) treatment.",[26,27],"Bleeding Post-mechanical Valve Replacement","Thromboembolism Post-mechanical Valve Replacement",[29,30,31,32,33],"Mechanical valve replacement","Vitamin K antagonist","INR targets","Bleeding","Thromboembolism","RECRUITING","2025-12-31",{"date":37,"type":38},"2026-01-06","ACTUAL",{"date":40,"type":38},"2019-09-05",{"date":42,"type":20},"2026-12-31",{"name":44,"class":45},"Population Health Research Institute","OTHER",35]