[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100515089":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":96,"collaborators":26,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":100,"sex":105,"minAge":106,"maxAge":26,"enrollmentInfo":107,"targetDuration":26,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":26,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Radboud University Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment arm","EXPERIMENTAL","Ticagrelor monotherapy instead of dual antiplatelet therapy (aspirin plus ticagrelor)",[13],"Drug: Ticagrelor",{"label":15,"type":16,"description":17,"interventionNames":18},"Control arm","ACTIVE_COMPARATOR","Dual antiplatelet therapy (aspirin plus ticagrelor) for 12 months.",[13,19],"Drug: Aspirin",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Ticagrelor","Ticagrelor monotherapy for 12 months",[15,9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Aspirin","Dual antiplatelet therapy (aspirin plus ticagrelor) for 12 months",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Peter Damman, MD, PhD, FESC","CONTACT","0031243616785","peter.damman@radboudumc.nl",[38,53,64,75,86],{"facility":39,"status":40,"city":41,"state":26,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Noordwest Ziekenhuisgroep Alkmaar","RECRUITING","Alkmaar","Netherlands","NL",{"type":45,"coordinates":46},"Point",[47,48],4.74861,52.63167,{"lat":48,"lon":47},[51],{"name":52,"role":34,"phone":26,"phoneExt":26,"email":26},"Ton Heestermans, MD, PhD",{"facility":54,"status":40,"city":55,"state":26,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"Amsterdam UMC","Amsterdam",{"type":45,"coordinates":57},[58,59],4.88969,52.37403,{"lat":59,"lon":58},[62],{"name":63,"role":34,"phone":26,"phoneExt":26,"email":26},"Bimmer Claessen, MD, PhD",{"facility":65,"status":40,"city":66,"state":26,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Rijnstate","Arnhem",{"type":45,"coordinates":68},[69,70],5.91111,51.98,{"lat":70,"lon":69},[73],{"name":74,"role":34,"phone":26,"phoneExt":26,"email":26},"Hans Van Rees, MD, PhD",{"facility":76,"status":40,"city":77,"state":26,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"Medisch Spectrum Twente","Enschede",{"type":45,"coordinates":79},[80,81],6.89583,52.21833,{"lat":81,"lon":80},[84],{"name":85,"role":34,"phone":26,"phoneExt":26,"email":26},"Clemens Von Birgelen, MD, Prof",{"facility":87,"status":40,"city":88,"state":26,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Radboudumc","Nijmegen",{"type":45,"coordinates":90},[91,92],5.85278,51.8425,{"lat":92,"lon":91},[95],{"name":33,"role":34,"phone":26,"phoneExt":26,"email":26},{"type":97,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100515089","safety-of-ticagrelor-monotherapy-after-primary-percutaneous-coronary-intervention-for-st-elevation-myocardial-infarction-and-the-effect-on-intramyocardial-haemorrhage-100515089",false,"NCT05986968","Safety of Ticagrelor Monotherapy After Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction and the Effect on Intramyocardial Haemorrhage","STOP-IMH","Inclusion Criteria:\n\n* Clinical and electrocardiographical diagnosis of STEMI\n* Successful PCI (according to the treating physician) of the infarct-related vessel with a modern drug-eluting stent (DES)\n\nExclusion Criteria:\n\n* Known allergy or contraindication for aspirin, ticagrelor or prasugrel.\n* Previous PCI or MI less than 12 months ago\n* Previous cardiac surgery\n* Participation in another clinical cardiology study or study concerning platelet aggregation\u002F thrombosis. (unless the antithrombotic therapy prescribed in this other study will end due to clinical reasons (e.g. the STEMI))\n* Pregnancy and breast feeding\n* Concurrent use of oral anticoagulants (OAC)\n* The periprocedural use of GPIIb\u002FIIIa inhibitors\n* Planned surgical intervention within 12 months of PCI\n* Creatinine clearance \\\u003C30mL\u002Fmin or dialysis\n* PCI of stent thrombosis\n* Suboptimal stent result as judged by the interventional cardiologist.\n* Life expectancy shorter than 13 months.\n* Contra-indications for MRI or unable to undergo MRI (only applicable for the CMR subgroup population).","ALL","18 Years",{"count":108,"type":109},200,"ESTIMATED","INTERVENTIONAL",[112],"NA","The main goal of this clinical trial is to assess whether direct omission of aspirin after Percutaneous Coronary Intervention (PCI) with the continuation of ticagrelor monotherapy for 12 months versus 12 months ticagrelor plus aspirin is equally safe regarding the incidence of ischemic events in patients with ST elevation myocardial infarction (STEMI). Furthermore, the two treatment strategies will be compared regarding the incidence and extent of intramyocardial haemorrhage (IMH) and infarct size in the first week after PCI as determined with Cardiac Magnetic Resonance (CMR). The secondary efficacy endpoint consists of clinical bleeding events and all-cause mortality. The main analyses will comprise of clinical outcomes in the first three months after primary PCI and of CMR results. In addition, we will report on clinical outcomes at thirteen months.",[115],"ST Elevation Myocardial Infarction","2024-09-20",{"date":118,"type":119},"2024-09-23","ACTUAL",{"date":121,"type":119},"2023-07-06",{"date":123,"type":109},"2025-12-01",{"name":5,"class":6},5]