[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100334586":3},{"organization":4,"outcomesModule":7,"designInfo":60,"detailedDescription":67,"studyPopulation":59,"armGroups":68,"interventions":80,"overallOfficials":88,"centralContacts":93,"locations":102,"responsibleParty":584,"collaborators":587,"id":590,"slug":591,"hasResults":592,"nctId":593,"briefTitle":594,"officialTitle":594,"acronym":595,"eligibilityCriteria":596,"healthyVolunteers":592,"sex":597,"minAge":598,"maxAge":59,"enrollmentInfo":599,"targetDuration":59,"studyType":602,"phases":603,"briefSummary":605,"conditions":606,"keywords":609,"overallStatus":105,"whyStopped":59,"lastUpdateSubmitDate":615,"lastUpdatePostDateStruct":616,"startDateStruct":619,"completionDateStruct":621,"leadSponsor":623,"locationsCount":624},{"fullName":5,"class":6},"Population Health Research Institute","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":59},[9,13],{"measure":10,"description":11,"timeFrame":12},"Thrombosis\u002Fthromboembolism","Number of patients who have at least one of the following: ischemic stroke, systemic thromboembolism, and valve thrombosis","Through study completion, an expected mean of 2-3 years",{"measure":14,"description":15,"timeFrame":12},"Major bleeding","Number of patients that have bleeding that results in the following:\n\n1. Death and\u002For,\n2. Symptomatic bleeding in critical area or organ (e.g. intracranial, intraspinal, intraocular, retroperitoneal, intraarticular, pericardial, in a non-operated joint, or intramuscular with compartment syndrome) and\u002For,\n3. Bleeding that causes drop of hemoglobin level by 20 g\u002FL or more, or that requires the transfusion of 2 or more units of packed red blood cells or whole blood",[17,20,23,26,29,32,35,38,41,44,47,50,53,56],{"measure":18,"description":19,"timeFrame":12},"All cause mortality","Selected rather than cardiovascular mortality, as cause-specific mortality is often difficult to ascertain or define in complex cardiovascular patients in whom multi-end-organ dysfunction may accompany cardiovascular decline.",{"measure":21,"description":22,"timeFrame":12},"All clinically important bleeding","Number of patients that experience all clinically important bleeding (major and minor)",{"measure":24,"description":25,"timeFrame":12},"Minor bleeding","Number of patients that experience a bleed that does not meet major bleeding criteria",{"measure":27,"description":28,"timeFrame":12},"All stroke","Number of patients that experience a strokes, including ischemic stroke, ischemic with secondary transformation, stroke of uncertain classification and hemorrhagic stroke",{"measure":30,"description":31,"timeFrame":12},"Ischemic stroke","Number of patients that experience an ischemic stroke, defined as focal brain infarction caused by an arterial (or rarely venous) obstruction and as documented by CT\u002FMRI that is normal or shows an infarct in the clinicall expected area",{"measure":33,"description":34,"timeFrame":12},"Hemorrhagic stroke","Number of patients that experience a hemorrhagic stroke, defined as requiring neuroimaging or autopsy confirmation, and includes two subcategories: primary intracerebral hemorrhage and primary subarachnoid hemorrhage",{"measure":36,"description":37,"timeFrame":12},"Type 1, 2 or 3 myocardial infarction","Number of patients who experience a type 1, 2 or 3 myocardial infarction",{"measure":39,"description":40,"timeFrame":12},"Systemic thromboembolism","Number of patients who experience a systemic thromboembolism",{"measure":42,"description":43,"timeFrame":12},"Valve thrombosis","Number of patients who experience a valve thrombosis",{"measure":45,"description":46,"timeFrame":12},"Pulmonary embolism","Number of patients who experience a pulmonary embolism",{"measure":48,"description":49,"timeFrame":12},"Deep vein thrombosis","Number of patients who experience a deep vein thrombosis",{"measure":51,"description":52,"timeFrame":12},"New renal replacement therapy","Number of patients requiring new renal replacement therapy",{"measure":54,"description":55,"timeFrame":12},"Time in therapeutic range","The percentage of time the patient's INR was within the target range",{"measure":57,"description":58,"timeFrame":12},"Proportion of patients with extreme INR values (>4)","The proportion of patients with at least one reported INR value above 4",null,{"allocation":61,"interventionModel":62,"interventionModelDescription":63,"primaryPurpose":64,"observationalModel":59,"timePerspective":59,"maskingInfo":65},"RANDOMIZED","PARALLEL","A prospective, randomized, open-label, blinded end-point (PROBE) clinical trial.","TREATMENT",{"masking":66,"maskingDescription":59,"whoMasked":59},"NONE","Warfarin (Coumadin) is a blood thinner used to prevent blood clot formation in patients with mechanical heart valves. Blood clots can block blood flow to the brain, heart, or other parts of the body. Mechanical heart valves increases the risk of clot so patients with a mechanical heart valve must take warfarin to reduce their risk of stroke and other blood clot-related problems.\n\nThe degree to which warfarin 'works' varies from person to person, and so dosage is determined by measuring each person's response to the drug as an 'international normalized ratio' or INR. A patient with an INR over 1.0 has blood that takes longer to clot than average, and increasing INR values represent increasing time required for blood to clot. While an INR over 1.0 decreases clotting risk, it also increases bleeding risk. It is important to carefully balance these risks.\n\nSpecific INR targets have been recommended for patients with a mechanical heart valve, but these recommendations differ between scientific groups and are based on low quality evidence. Recent studies suggest that a lower INR target range than is currently recommended can be used safely. A laboratory study showed that warfarin effectively prevents blood clot formation on mechanical heart valves as long as the INR is 1.5 or above. Two moderately-sized clinical studies showed that an INR target range of 1.5-2.5 resulted in less bleeding than the usual higher target range without increasing blood clot formation or stroke in patients with a newer valve model. Whether we could use a lower INR target range for patients with a mechanical aortic valve remains controversial.\n\nThis 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.",[69,75],{"label":70,"type":71,"description":72,"interventionNames":73},"Reduced INR Target","EXPERIMENTAL","Warfarin therapy will be titrated to a target INR in the range of 1.5 to 2.5.",[74],"Drug: Warfarin",{"label":76,"type":77,"description":78,"interventionNames":79},"Standard INR Target","ACTIVE_COMPARATOR","Warfarin therapy will be titrated to a \"standard of care\" target INR range.",[74],[81],{"type":82,"name":83,"description":84,"armGroupLabels":85,"otherNames":86},"DRUG","Warfarin","Participants in both arms will be on warfarin therapy post-mechanical valve replacement as is standard, but will have different INR target ranges.",[70,76],[87],"Coumadin",[89],{"name":90,"affiliation":91,"role":92},"Emilie Belley-Côté, MD, MSc","McMaster University","PRINCIPAL_INVESTIGATOR",[94,99],{"name":90,"role":95,"phone":96,"phoneExt":97,"email":98},"CONTACT","905-527-4322","40306","emilie.belley-cote@phri.ca",{"name":100,"role":95,"phone":96,"phoneExt":97,"email":101},"Richard Whitlock, MD, PhD","richard.whitlock@phri.ca",[103,121,134,146,158,171,187,201,215,228,240,253,269,282,295,308,321,336,351,363,375,389,404,418,433,446,458,472,487,500,513,526,542,557,569],{"facility":104,"status":105,"city":106,"state":107,"zip":108,"country":109,"countryCode":110,"cosmosGeoPoint":111,"geoPoint":116,"contacts":117},"Ziekenhuis Oost-Limburg","RECRUITING","Genk","Limburg","3600","Belgium","BE",{"type":112,"coordinates":113},"Point",[114,115],5.50082,50.965,{"lat":115,"lon":114},[118,120],{"name":119,"role":95,"phone":59,"phoneExt":59,"email":59},"Philippe Bertrand, MD",{"name":119,"role":92,"phone":59,"phoneExt":59,"email":59},{"facility":122,"status":105,"city":123,"state":124,"zip":125,"country":109,"countryCode":110,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"AZ Oostende","Ostend","West-Vlaanderen","8400",{"type":112,"coordinates":127},[128,129],2.927,51.21551,{"lat":129,"lon":128},[132],{"name":133,"role":92,"phone":59,"phoneExt":59,"email":59},"Johannes Heymeriks, MD",{"facility":135,"status":105,"city":136,"state":59,"zip":137,"country":109,"countryCode":110,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"Imelda Hospital","Keerbergen","2820",{"type":112,"coordinates":139},[140,141],4.63434,51.00295,{"lat":141,"lon":140},[144],{"name":145,"role":92,"phone":59,"phoneExt":59,"email":59},"Herbert De Praetere, MD",{"facility":147,"status":105,"city":148,"state":59,"zip":149,"country":109,"countryCode":110,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"Universitair Ziekenhuis Leuven","Leuven","3000",{"type":112,"coordinates":151},[152,153],4.70093,50.87959,{"lat":153,"lon":152},[156],{"name":157,"role":92,"phone":59,"phoneExt":59,"email":59},"Filip Rega, MD",{"facility":159,"status":105,"city":160,"state":59,"zip":59,"country":161,"countryCode":162,"cosmosGeoPoint":163,"geoPoint":167,"contacts":168},"University of Botswana, at Princess Marina Hospital","Gaborone","Botswana","BW",{"type":112,"coordinates":164},[165,166],25.90859,-24.65451,{"lat":166,"lon":165},[169],{"name":170,"role":92,"phone":59,"phoneExt":59,"email":59},"Julius Mwita, MD, MSc",{"facility":172,"status":105,"city":173,"state":174,"zip":175,"country":176,"countryCode":177,"cosmosGeoPoint":178,"geoPoint":182,"contacts":183},"Sociedade Hospitalar Angelina Caron","Campina Grande do Sul","Paraná","83430-000","Brazil","BR",{"type":112,"coordinates":179},[180,181],-49.05528,-25.30556,{"lat":181,"lon":180},[184,186],{"name":185,"role":95,"phone":59,"phoneExt":59,"email":59},"Dalton Precoma, MD",{"name":185,"role":92,"phone":59,"phoneExt":59,"email":59},{"facility":188,"status":105,"city":189,"state":190,"zip":191,"country":176,"countryCode":177,"cosmosGeoPoint":192,"geoPoint":196,"contacts":197},"HEW Cardiologia LTDA","Joinville","Santa Catarina","89204-250",{"type":112,"coordinates":193},[194,195],-48.84556,-26.30444,{"lat":195,"lon":194},[198,200],{"name":199,"role":95,"phone":59,"phoneExt":59,"email":59},"Conrado R. Hoffmann Filho, MD",{"name":199,"role":92,"phone":59,"phoneExt":59,"email":59},{"facility":202,"status":105,"city":203,"state":204,"zip":205,"country":176,"countryCode":177,"cosmosGeoPoint":206,"geoPoint":210,"contacts":211},"InCor-HCFMUSP","Cerqueira César","São Paulo","05403-000",{"type":112,"coordinates":207},[208,209],-49.16611,-23.03556,{"lat":209,"lon":208},[212,214],{"name":213,"role":95,"phone":59,"phoneExt":59,"email":59},"Roney Sampaio, MD",{"name":213,"role":92,"phone":59,"phoneExt":59,"email":59},{"facility":216,"status":105,"city":217,"state":59,"zip":59,"country":176,"countryCode":177,"cosmosGeoPoint":218,"geoPoint":222,"contacts":223},"Fundação Universitária de Cardiologia mantededora do Instituto de Cardiologia e Transplantes do Distrito Federal","Brasília",{"type":112,"coordinates":219},[220,221],-47.92972,-15.77972,{"lat":221,"lon":220},[224,226],{"name":225,"role":95,"phone":59,"phoneExt":59,"email":59},"Kaytussia Sena",{"name":227,"role":92,"phone":59,"phoneExt":59,"email":59},"Adegil Silva, MD",{"facility":229,"status":105,"city":204,"state":59,"zip":59,"country":176,"countryCode":177,"cosmosGeoPoint":230,"geoPoint":234,"contacts":235},"Dante Pazzanese Institute of Cardiology",{"type":112,"coordinates":231},[232,233],-46.63611,-23.5475,{"lat":233,"lon":232},[236,238],{"name":237,"role":95,"phone":59,"phoneExt":59,"email":59},"Mayara Silva",{"name":239,"role":92,"phone":59,"phoneExt":59,"email":59},"Auristela Ramos, MD",{"facility":241,"status":105,"city":242,"state":59,"zip":59,"country":243,"countryCode":244,"cosmosGeoPoint":245,"geoPoint":249,"contacts":250},"St. Elizabeth Catholic General Hospital","Kumbo","Cameroon","CM",{"type":112,"coordinates":246},[247,248],10.66667,6.2,{"lat":248,"lon":247},[251],{"name":252,"role":92,"phone":59,"phoneExt":59,"email":59},"Tantchou Tchoumi Jacques Cabral, MD, PhD",{"facility":254,"status":255,"city":256,"state":257,"zip":258,"country":259,"countryCode":260,"cosmosGeoPoint":261,"geoPoint":265,"contacts":266},"Nova Scotia Health Authority","NOT_YET_RECRUITING","Halifax","Nova Scotia","B3S 0H6","Canada","CA",{"type":112,"coordinates":262},[263,264],-63.57688,44.64269,{"lat":264,"lon":263},[267],{"name":268,"role":92,"phone":59,"phoneExt":59,"email":59},"Robbie Stewart, MD",{"facility":270,"status":105,"city":271,"state":272,"zip":273,"country":259,"countryCode":260,"cosmosGeoPoint":274,"geoPoint":278,"contacts":279},"Hamilton General Hospital","Hamilton","Ontario","L8L 2X2",{"type":112,"coordinates":275},[276,277],-79.84963,43.25011,{"lat":277,"lon":276},[280],{"name":281,"role":95,"phone":96,"phoneExt":97,"email":98},"Emilie Belley-Cote, MD",{"facility":283,"status":105,"city":284,"state":272,"zip":285,"country":259,"countryCode":260,"cosmosGeoPoint":286,"geoPoint":290,"contacts":291},"London Health Sciences Centre Research Inc.","London","N6C 2R5",{"type":112,"coordinates":287},[288,289],-81.23304,42.98339,{"lat":289,"lon":288},[292,294],{"name":293,"role":95,"phone":59,"phoneExt":59,"email":59},"Linrui Guo, MD",{"name":293,"role":92,"phone":59,"phoneExt":59,"email":59},{"facility":296,"status":105,"city":297,"state":272,"zip":298,"country":259,"countryCode":260,"cosmosGeoPoint":299,"geoPoint":303,"contacts":304},"The Ottawa Hospital Research Institute","Ottawa","K1H 8L6",{"type":112,"coordinates":300},[301,302],-75.69812,45.41117,{"lat":302,"lon":301},[305,307],{"name":306,"role":95,"phone":59,"phoneExt":59,"email":59},"Joseph Shaw, MD",{"name":306,"role":92,"phone":59,"phoneExt":59,"email":59},{"facility":309,"status":105,"city":310,"state":311,"zip":312,"country":259,"countryCode":260,"cosmosGeoPoint":313,"geoPoint":317,"contacts":318},"Jewish General Hospital","Montreal","Quebec","H3T 1E2",{"type":112,"coordinates":314},[315,316],-73.58781,45.50884,{"lat":316,"lon":315},[319],{"name":320,"role":95,"phone":59,"phoneExt":59,"email":59},"Mark Blostein, MD",{"facility":322,"status":105,"city":323,"state":59,"zip":59,"country":324,"countryCode":325,"cosmosGeoPoint":326,"geoPoint":330,"contacts":331},"Fuwai Hospital, CAMS & PUMC","Beijing","China","CN",{"type":112,"coordinates":327},[328,329],116.39723,39.9075,{"lat":329,"lon":328},[332,334],{"name":333,"role":95,"phone":59,"phoneExt":59,"email":59},"Xiaolu Sun, MD",{"name":335,"role":92,"phone":59,"phoneExt":59,"email":59},"Yan Liang, MD, PhD",{"facility":337,"status":105,"city":338,"state":339,"zip":340,"country":341,"countryCode":342,"cosmosGeoPoint":343,"geoPoint":347,"contacts":348},"Esbjerg & Grindsted Hospital - University Hospital of Southern Denmark","Esbjerg","Region Syddanmark","6700","Denmark","DK",{"type":112,"coordinates":344},[345,346],8.45187,55.47028,{"lat":346,"lon":345},[349],{"name":350,"role":92,"phone":59,"phoneExt":59,"email":59},"Axel Brandes, MD",{"facility":352,"status":105,"city":353,"state":59,"zip":354,"country":341,"countryCode":342,"cosmosGeoPoint":355,"geoPoint":359,"contacts":360},"Southern Jutland Hospital","Aabenraa","6200",{"type":112,"coordinates":356},[357,358],9.41741,55.04434,{"lat":358,"lon":357},[361],{"name":362,"role":92,"phone":59,"phoneExt":59,"email":59},"Michael S Hansen, MD",{"facility":364,"status":105,"city":365,"state":59,"zip":366,"country":341,"countryCode":342,"cosmosGeoPoint":367,"geoPoint":371,"contacts":372},"Aarhus University Hospital","Aarhus","8200",{"type":112,"coordinates":368},[369,370],10.21076,56.15674,{"lat":370,"lon":369},[373],{"name":374,"role":92,"phone":59,"phoneExt":59,"email":59},"Erik Grove, MD, PhD",{"facility":376,"status":105,"city":377,"state":59,"zip":378,"country":379,"countryCode":380,"cosmosGeoPoint":381,"geoPoint":385,"contacts":386},"Universitätsklinikum Jena","Jena","07747","Germany","DE",{"type":112,"coordinates":382},[383,384],11.5899,50.92878,{"lat":384,"lon":383},[387],{"name":388,"role":92,"phone":59,"phoneExt":59,"email":59},"Torsten Doenst, MD, PhD",{"facility":390,"status":105,"city":391,"state":392,"zip":393,"country":394,"countryCode":395,"cosmosGeoPoint":396,"geoPoint":400,"contacts":401},"Città di Lecce Hospital","Lecce","Apulia","73100","Italy","IT",{"type":112,"coordinates":397},[398,399],18.17244,40.35481,{"lat":399,"lon":398},[402],{"name":403,"role":92,"phone":59,"phoneExt":59,"email":59},"Giuseppe Santarpino, MD",{"facility":405,"status":105,"city":406,"state":59,"zip":407,"country":394,"countryCode":395,"cosmosGeoPoint":408,"geoPoint":412,"contacts":413},"Azienda Ospedaliero Universitaria Policlinico Riuniti Foggia","Foggia","71122",{"type":112,"coordinates":409},[410,411],15.55188,41.45845,{"lat":411,"lon":410},[414,416],{"name":415,"role":92,"phone":59,"phoneExt":59,"email":59},"Domenico Paparella, MD",{"name":417,"role":92,"phone":59,"phoneExt":59,"email":59},"Gaetano Serviddio, MD",{"facility":419,"status":105,"city":420,"state":421,"zip":422,"country":423,"countryCode":424,"cosmosGeoPoint":425,"geoPoint":429,"contacts":430},"Shahid Gangalal National Heart Centre","Kathmandu","Bagmati","44600","Nepal","NP",{"type":112,"coordinates":426},[427,428],85.3206,27.70169,{"lat":428,"lon":427},[431],{"name":432,"role":92,"phone":59,"phoneExt":59,"email":59},"Raamesh Koirala, MD",{"facility":434,"status":105,"city":435,"state":436,"zip":437,"country":423,"countryCode":424,"cosmosGeoPoint":438,"geoPoint":442,"contacts":443},"Nobel Medical College and Teaching Hospital","Biratnagar","Koshi","56613",{"type":112,"coordinates":439},[440,441],87.27007,26.45505,{"lat":441,"lon":440},[444],{"name":445,"role":92,"phone":59,"phoneExt":59,"email":59},"Rajesh Nepal, MD",{"facility":447,"status":105,"city":448,"state":436,"zip":449,"country":423,"countryCode":424,"cosmosGeoPoint":450,"geoPoint":454,"contacts":455},"BP Koirala Institute of Health Sciences","Dharān","56700",{"type":112,"coordinates":451},[452,453],87.27972,26.81436,{"lat":453,"lon":452},[456],{"name":457,"role":92,"phone":59,"phoneExt":59,"email":59},"Sanjib Kumar Sharma, MD",{"facility":459,"status":105,"city":460,"state":59,"zip":461,"country":462,"countryCode":463,"cosmosGeoPoint":464,"geoPoint":468,"contacts":469},"Erasmus University Medical Centre","Rotterdam","3015","Netherlands","NL",{"type":112,"coordinates":465},[466,467],4.47917,51.9225,{"lat":467,"lon":466},[470],{"name":471,"role":92,"phone":59,"phoneExt":59,"email":59},"Jolien Roos-Hesselink, MD",{"facility":473,"status":105,"city":474,"state":475,"zip":476,"country":477,"countryCode":478,"cosmosGeoPoint":479,"geoPoint":483,"contacts":484},"Shifa Clinical Research Center","Islamabad","Capital Territory","44000","Pakistan","PK",{"type":112,"coordinates":480},[481,482],73.04329,33.72148,{"lat":482,"lon":481},[485],{"name":486,"role":92,"phone":59,"phoneExt":59,"email":59},"Muhammad Asghar Nawaz, MBBS",{"facility":488,"status":105,"city":489,"state":59,"zip":59,"country":490,"countryCode":491,"cosmosGeoPoint":492,"geoPoint":496,"contacts":497},"Meshalkin National Medical Research Center","Novosibirsk","Russia","RU",{"type":112,"coordinates":493},[494,495],82.93175,55.02259,{"lat":495,"lon":494},[498],{"name":499,"role":95,"phone":59,"phoneExt":59,"email":59},"Alexander Bogachev-Prokophiev, MD",{"facility":501,"status":105,"city":502,"state":59,"zip":59,"country":503,"countryCode":504,"cosmosGeoPoint":505,"geoPoint":509,"contacts":510},"King Faisal Specialist Hospital & Research Centre","Riyadh","Saudi Arabia","SA",{"type":112,"coordinates":506},[507,508],46.72185,24.68773,{"lat":508,"lon":507},[511],{"name":512,"role":92,"phone":59,"phoneExt":59,"email":59},"Eman Alrajhi, MD",{"facility":514,"status":105,"city":515,"state":59,"zip":59,"country":516,"countryCode":59,"cosmosGeoPoint":517,"geoPoint":521,"contacts":522},"Soonchunhyang University Gumi Hospital","Gumi","South Korea",{"type":112,"coordinates":518},[519,520],128.336,36.1136,{"lat":520,"lon":519},[523,525],{"name":524,"role":95,"phone":59,"phoneExt":59,"email":59},"Hun-Gyu Hwang, MD",{"name":524,"role":92,"phone":59,"phoneExt":59,"email":59},{"facility":527,"status":105,"city":528,"state":59,"zip":529,"country":530,"countryCode":531,"cosmosGeoPoint":532,"geoPoint":536,"contacts":537},"Hospital de la Santa Creu i Sant Pau","Barcelona","08025","Spain","ES",{"type":112,"coordinates":533},[534,535],2.15899,41.38879,{"lat":535,"lon":534},[538,540],{"name":539,"role":95,"phone":59,"phoneExt":59,"email":59},"Ekaterine Popova, MD",{"name":541,"role":92,"phone":59,"phoneExt":59,"email":59},"Juan Carles Souto Andres, MD",{"facility":543,"status":105,"city":544,"state":545,"zip":546,"country":547,"countryCode":548,"cosmosGeoPoint":549,"geoPoint":553,"contacts":554},"Golden Jubilee National Hospital","Clydebank","Glasgow","G81 4HX","United Kingdom","UK",{"type":112,"coordinates":550},[551,552],-4.4057,55.90137,{"lat":552,"lon":551},[555],{"name":556,"role":92,"phone":59,"phoneExt":59,"email":59},"Nawwar Al-Attar, FRCS, FETCS, PhD",{"facility":558,"status":105,"city":559,"state":59,"zip":560,"country":547,"countryCode":548,"cosmosGeoPoint":561,"geoPoint":565,"contacts":566},"Liverpool Heart & Chest Hospital","Liverpool","L143PE",{"type":112,"coordinates":562},[563,564],-2.97794,53.41058,{"lat":564,"lon":563},[567],{"name":568,"role":92,"phone":59,"phoneExt":59,"email":59},"Bilal Kirmani, MD",{"facility":570,"status":105,"city":571,"state":59,"zip":59,"country":547,"countryCode":548,"cosmosGeoPoint":572,"geoPoint":576,"contacts":577},"South Tees Hospitals NHS Foundation Trust of The James Cook University Hospital","Middlesbrough",{"type":112,"coordinates":573},[574,575],-1.23483,54.57623,{"lat":575,"lon":574},[578,580,582],{"name":579,"role":95,"phone":59,"phoneExt":59,"email":59},"Carmen Neave",{"name":581,"role":92,"phone":59,"phoneExt":59,"email":59},"Enoch Akowuah, MD FRCSC",{"name":583,"role":92,"phone":59,"phoneExt":59,"email":59},"David Austin, MD",{"type":92,"investigatorFullName":585,"investigatorTitle":586,"investigatorAffiliation":5,"oldNameTitle":59,"oldOrganization":59},"Emilie Belley-Cote","Principal Investigator",[588],{"name":589,"class":6},"Hamilton Health Sciences Corporation","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":600,"type":601},2625,"ESTIMATED","INTERVENTIONAL",[604],"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.",[607,608],"Bleeding Post-mechanical Valve Replacement","Thromboembolism Post-mechanical Valve Replacement",[610,611,612,613,614],"Mechanical valve replacement","Vitamin K antagonist","INR targets","Bleeding","Thromboembolism","2025-12-31",{"date":617,"type":618},"2026-01-06","ACTUAL",{"date":620,"type":618},"2019-09-05",{"date":622,"type":601},"2026-12-31",{"name":5,"class":6},35]