[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570664":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":40,"responsibleParty":191,"collaborators":193,"id":217,"slug":218,"hasResults":219,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":223,"eligibilityCriteria":224,"healthyVolunteers":219,"sex":225,"minAge":226,"maxAge":26,"enrollmentInfo":227,"targetDuration":26,"studyType":230,"phases":231,"briefSummary":233,"conditions":234,"keywords":237,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":263},{"fullName":5,"class":6},"University of Aarhus","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Aspirin alone","EXPERIMENTAL","Treatment with aspirin alone. The intervention is removal of treatment with fondaparinux",[13],"Drug: Aspirin",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Treatment - Aspirin and Fondaparinux","ACTIVE_COMPARATOR","Standard treatment regime with Aspirin in combination with Fondaparinux.",[13,19],"Drug: Fondaparinux Sodium",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Aspirin","Aspirin bolus of 300 mg followed by 75 mg daily until CAG",[9,15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Fondaparinux Sodium","Fondaprinux 2.5 mg subcutaneus daily until CAG (1.5 mg for patients with eGFR 20-50 ml\u002Fmin\u002F1.73m2)",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Christian B Fur, MD","CONTACT","+4524918071","chbyni@rm.dk",{"name":38,"role":34,"phone":26,"phoneExt":26,"email":39},"Christian J Terkelsen, MD, PhD, DmSC","christian.terkelsen@skejby.rm.dk",[41,60,75,88,103,118,132,146,163,177],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Regionshospitalet Gødstrup","RECRUITING","Herning","Region Midt","7400","Denmark","DK",{"type":50,"coordinates":51},"Point",[52,53],8.97662,56.13615,{"lat":53,"lon":52},[56],{"name":57,"role":34,"phone":58,"phoneExt":26,"email":59},"Morten Würtz, MD, PhD","+4540138703","mortwurt@rm.dk",{"facility":61,"status":62,"city":63,"state":45,"zip":64,"country":47,"countryCode":48,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Regionshospitalet Horsens","NOT_YET_RECRUITING","Horsens","8700",{"type":50,"coordinates":66},[67,68],9.85034,55.86066,{"lat":68,"lon":67},[71],{"name":72,"role":34,"phone":73,"phoneExt":26,"email":74},"Claus Pedersen, MD, PhD","+4578426701","clapes@rm.dk",{"facility":76,"status":43,"city":77,"state":45,"zip":26,"country":47,"countryCode":48,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Regionshospitalet Viborg","Viborg",{"type":50,"coordinates":79},[80,81],9.40201,56.45319,{"lat":81,"lon":80},[84],{"name":85,"role":34,"phone":86,"phoneExt":26,"email":87},"Hanne Søndergaard, MD, PhD","+4578447042","hanne.soendergaard@viborg.rm.dk",{"facility":89,"status":62,"city":90,"state":91,"zip":92,"country":47,"countryCode":48,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Aalborg Universitetshospital","Aalborg","Region Nord","9000",{"type":50,"coordinates":94},[95,96],9.9187,57.048,{"lat":96,"lon":95},[99],{"name":100,"role":34,"phone":101,"phoneExt":26,"email":102},"Ashkan Eftekhari, MD, Ass. Professor, PhD","+4597664465","asef@rn.dk",{"facility":104,"status":43,"city":105,"state":106,"zip":107,"country":47,"countryCode":48,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Sygehus Søndejylland, Aabenraa","Aabenraa","Region Syd","6200",{"type":50,"coordinates":109},[110,111],9.41741,55.04434,{"lat":111,"lon":110},[114],{"name":115,"role":34,"phone":116,"phoneExt":26,"email":117},"Ghassan Jadou, MD","+4542788489","ghassan.jadou@rsyd.dk",{"facility":119,"status":62,"city":120,"state":106,"zip":121,"country":47,"countryCode":48,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Esbjerg Sygehus","Esbjerg","6700",{"type":50,"coordinates":123},[124,125],8.45187,55.47028,{"lat":125,"lon":124},[128],{"name":129,"role":34,"phone":130,"phoneExt":26,"email":131},"Christian Fallesen, MD, PhD","+4579185054","christian.oliver.fallesen@rsyd.dk",{"facility":133,"status":43,"city":134,"state":106,"zip":135,"country":47,"countryCode":48,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"Sygehus Lillebælt, Kolding","Kolding","6000",{"type":50,"coordinates":137},[138,139],9.47216,55.4904,{"lat":139,"lon":138},[142],{"name":143,"role":34,"phone":144,"phoneExt":26,"email":145},"Remmon Washington, MD","+4576362000","remmon.washington2@rsyd.dk",{"facility":147,"status":43,"city":148,"state":106,"zip":149,"country":47,"countryCode":48,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"Odense Universitetshospital","Odense","5000",{"type":50,"coordinates":151},[152,153],10.38831,55.39594,{"lat":153,"lon":152},[156,160],{"name":157,"role":34,"phone":158,"phoneExt":26,"email":159},"Gro Egholm, MD, PhD","+4566113333","gro.egholm@rsyd.dk",{"name":161,"role":162,"phone":26,"phoneExt":26,"email":26},"Jens Flensted Lassen, MD, Prof, PhD","PRINCIPAL_INVESTIGATOR",{"facility":164,"status":43,"city":165,"state":106,"zip":166,"country":47,"countryCode":48,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"Sygehus Lillebælt, Vejle","Vejle","7100",{"type":50,"coordinates":168},[169,170],9.5357,55.70927,{"lat":170,"lon":169},[173],{"name":174,"role":34,"phone":175,"phoneExt":26,"email":176},"Dilek Alan, MD","+4579465037","dilek.hunerel.alan@rsyd.dk",{"facility":178,"status":43,"city":179,"state":26,"zip":180,"country":47,"countryCode":48,"cosmosGeoPoint":181,"geoPoint":185,"contacts":186},"Aarhus University Hospital, Department of Cardiology","Aarhus N","8200",{"type":50,"coordinates":182},[183,184],10.17317,56.20367,{"lat":184,"lon":183},[187,188,190],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"name":38,"role":34,"phone":26,"phoneExt":26,"email":189},"Christian.terkelsen@skejby.rm.dk",{"name":33,"role":162,"phone":26,"phoneExt":26,"email":26},{"type":192,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[194,196,198,200,202,204,206,208,211,213,215],{"name":195,"class":6},"Danske Regioner",{"name":197,"class":6},"Aalborg University Hospital",{"name":199,"class":6},"Odense University Hospital",{"name":201,"class":6},"Rigshospitalet, Denmark",{"name":203,"class":6},"Randers Regional Hospital",{"name":205,"class":6},"Viborg Regional Hospital",{"name":207,"class":6},"Gødstrup Hospital",{"name":209,"class":210},"Sydvestjysk Hospital Esbjerg","UNKNOWN",{"name":212,"class":210},"Lillebaelt Hospital, Kolding and Vejle, Denmark",{"name":214,"class":6},"Hospital of Southern Jutland",{"name":216,"class":6},"Horsens Hospital","100570664","phase-4-treatment-with-aspirin-alone-versus-aspirin-in-combination-with-fondaparinux-before-early-coronary-assessment-in-patients-with-non-st-elevation-myocardial-infarction-100570664",false,"NCT06710184","Treatment With Aspirin Alone Versus Aspirin in Combination With Fondaparinux Before Early Coronary Assessment in Patients With Non-ST-Elevation Myocardial Infarction","Aspirin Versus Aspirin and Fondaparinux Prior to Early Invasive Strategy in Patients With NSTEMI","FOXY","Inclusion Criteria:\n\n* Diagnosis of NSTEMI verified by:\n\n  * Rise or\u002Fand fall in cardiac troponin (cTN) and\n  * Symptoms of acute ischemia or ECG-changes compatible with acute ischemia.\n* Age above 18 years old\n* Expected remaining lifespan above 1 year\n* Informed consent\n\nExclusion Criteria:\n\n* Treatment with any anticoagulants before enrollment and randomization\n\n  * Including any direct anticoagulant (DOAC), LMWH, UFH or warfarin.\n* Not possible with CAG and PCI within 72 hours\n* Unsuitable for CAG and possible PCI due to poor condition\n* Estimated glomerular filtration rate (eGFR) \\\u003C 20 ml\u002Fmin\u002F1.73m2\n* Known liver disease\n* Active bleeding or high risk of bleeding where treatment with Fondaparinux is contraindicated.\n* Anemia (B-Hemoglobin \\\u003C 6.0 mmol\u002Fl)\n* Pregnancy or breastfeeding\n* Endocarditis\n* Indication for acute CAG before enrollment and randomization:\n\n  * ST-elevation Myocardial Infarction (STEMI)\n  * Patients classified as \"Very High Risk\" according to ESC guidelines, defined as(1):\n\n    * Hemodynamic instability (in need of inotropic support) or cardiogenic shock (DANGER-SHOCK criteria (20)) at time of admission.\n    * Acute heart failure because of presumed acute ischemia\n    * Life-threatening arrhythmias or cardiac arrest\n    * Mechanical complications (such as papillary muscle rupture with acute mitral regurgitation, free wall rupture and interventricular rupture)","ALL","18 Years",{"count":228,"type":229},5076,"ESTIMATED","INTERVENTIONAL",[232],"PHASE4","The main goal of this study is to compare two treatments in patients with a specific type of heart attack called Non-ST-elevation Myocardial Infarction (NSTEMI). The investigators want to find out whether using aspirin alone is as effective and safer than using aspirin together with a second blood thinner called fondaparinux.\n\nBoth treatments will be given before a scheduled heart procedure called coronary angiography (CAG), which may include balloon dilation and stent placement (PCI) if needed.\n\nThe current guidelines recommend using aspirin in combination with a second blood thinner like fondaparinux before CAG and possible PCI. However, these recommendations are based on studies from the 1990s, a time when invasive procedures were not standard practice for these patients. In contrast, nearly all patients with NSTEMI in Denmark (96%) now undergo CAG within 72 hours. This change in practice raises questions about whether the older studies still provide a valid foundation for today's guidelines.\n\nThe study aims to answer two questions:\n\n1. Is aspirin alone as effective as aspirin combined with fondaparinux before early CAG and possible PCI?\n2. Is aspirin alone safer, with a lower risk of severe bleeding, compared to the combination treatment?\n\nTo answer these questions, the investigators will enroll about 5,000 patients with NSTEMI. Participants will be randomly assigned to receive either aspirin alone or aspirin with fondaparinux. The investigators will monitor them for 30 days to compare outcomes such as death, new heart attacks, the need for urgent CAG before the scheduled, and severe bleeding.",[235,236],"NSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI)","Acute Myocardial Infarction (AMI)",[238,239,23,240,241,242,243,244,245,246,247,248,249,250,251,252,253],"Acute Myocardial Infarction","Non-ST Segment Elevation Myocardial Infarction","Fondaparinux","Anticoagulation","Coronary Angiography","Percutaneus Coronary Intervention","Acute Coronay Syndrome","Early Invasive Treatment","Refractory ischemia","Bleeding risk","Mortality","Randomized Controlled Trial","New Myocardial Infarction","Non-inferiority Trial","Multicenter Study","Antithrombotic","2026-04-28",{"date":256,"type":257},"2026-05-04","ACTUAL",{"date":259,"type":257},"2025-05-01",{"date":261,"type":229},"2029-07-01",{"name":5,"class":6},10]