[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658704":3},{"organization":4,"outcomesModule":7,"designInfo":69,"detailedDescription":72,"studyPopulation":72,"armGroups":79,"interventions":90,"overallOfficials":96,"centralContacts":101,"locations":110,"responsibleParty":232,"collaborators":234,"id":260,"slug":261,"hasResults":262,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":266,"eligibilityCriteria":267,"healthyVolunteers":262,"sex":268,"minAge":269,"maxAge":72,"enrollmentInfo":270,"targetDuration":72,"studyType":273,"phases":274,"briefSummary":276,"conditions":277,"keywords":279,"overallStatus":283,"whyStopped":72,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":293},{"fullName":5,"class":6},"Vestre Viken Hospital Trust","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Hierarchical composite endpont","The net clinical benefit of discontinuing versus continuing aspirin in patients randomized 2-8 years after an index ACS event, using a hierarchical composite endpoint with a win-ratio framework that includes: 1. Cardiovascular death, 2. Intracranial bleeding, 3. Myocardial infarctions including stent thrombosis, 4. Ischemic stroke, 5. Major bleeding (BARC 3 and 5) requiring hospitalization. The components of the endpoints will be identified in The Norwegian Patient Registry and Cause of Death Registry using procedure and diagnostic codes.","From randomization to median 3.0 (minimum 1.0) years follow-up",[14,17],{"measure":15,"description":16,"timeFrame":12},"Risk of ischaemic disease","The cumulative risk of a composite of recurrent myocardial infarction including stent thrombosis, ischemic stroke, and cardiovascular death by randomization group. Events will be identified in the Norwegian Patient Registry and the Norwegian Cause of Death registry using procedure and diagnostic codes.",{"measure":18,"description":19,"timeFrame":12},"Risk of major bleedings","The cumulative risk of major bleedings, including intracranial and other major (BARC 3, 5) bleeding events requiring hospitalization by randomization group. Events will be identified in The Norwegian Patient Registry and the Cause of Death registry data with procedure and diagnostic codes.",[21,24,27,30,33,36,39,42,45,48,51,54,57,60,63,66],{"measure":22,"description":23,"timeFrame":12},"Subgroup analyses","The net clinical benefit of discontinuing versus continuing aspirin across subgroups by age, sex, Clinical Frailty Scale score \\\u003C4 vs. ≥4 (mild frailty), single vs. multi-vessel disease, and discontinuation 2-4 years vs. 4-8 years after index event. The net clinical benefit will be analyzed the same way as for the primary endpoint: a win-ratio framework using a hierarchical composite endpoint including both ischemic events and major bleeding events.",{"measure":25,"description":26,"timeFrame":12},"Risk of individual components of the primary endpoint","The cumulative risk of the individual components of the primary endpoint by randomization group. Events will be identified in The Norwegian Patient Registry and The Norwegian Cause of Death Registry using procedure and diagnostic codes.",{"measure":28,"description":29,"timeFrame":12},"Recurrent CVD hospitalisations","The cumulative risk of recurrent hospitalization for (any) cardiovascular disease by randomization status. Hospitalizations will be identified in registry data using diagnostic and procedure codes.",{"measure":31,"description":32,"timeFrame":12},"All-cause mortality","The cumulative risk of all-cause mortality by randomization group. All-cause mortality will be obtained from the Cause of Death Registry",{"measure":34,"description":35,"timeFrame":12},"Major and minor bleedings","Cumulative risk of major or minor bleedings (BARC 2,3,5) Minor bleedings will be assessed using 10 questions based on the International Society on Thrombosis and Haemostasis (ISTH) bleeding assessment approach. Major bleedings will be identified in the Norwegian Patient registry using diagnostic and procdedure codes.",{"measure":37,"description":38,"timeFrame":12},"Gastrointestinal ulcer","The cumulative risk of gastrointestinal ulcer by randomization group. Gastroinestinal ulcer is optained from both the Norwegian Patient registry and self-reported questionnaires.",{"measure":40,"description":41,"timeFrame":12},"Malignant diseases","Cumulative risk of incident malignant diseas by randomization group. Malignant disease will be obtained from the Cancer Registry of Norway.",{"measure":43,"description":44,"timeFrame":12},"Adherence to allocated treatment","Adherence to allocated treatment evaluated by redeemed prescriptions at the pharmacy. Obtained from The Norwegian Prescription Database.",{"measure":46,"description":47,"timeFrame":12},"Health economics","Cost-utilty analysis in relation to quality of life and a healthcare utilization by randomization group. Quality of life will be obtained by the EQ-5D questionnaire and healthcare utilization will be obtained from The Norwegian Patient Registry.",{"measure":49,"description":50,"timeFrame":12},"Changes in quality of life","Changes in quality of life by randomization group measured by EQ-5D questionnaire",{"measure":52,"description":53,"timeFrame":12},"Changes in lifestyle factors","Changes in lifestyle behaviour by randomization group measured by the NORCOR Lifestyle Questionnaire. The NORCOR lifestyle questionnaire includes queestions on smoking status and quitting motiviation, alcohol consumption, physical activity and body weight and height.\n\nSmoking status: never, former, current Physical activity: Assessed by a validated questionnaire form HUNT1 which assesses frequency (never, \\\u003Conce\u002Fweek, once\u002Fweek, two to three times\u002Fweek and almost every day), intensity (light, medium and vigorous), and duration (\\\u003C15 minutes (min), 15-29 min, 30-60 min, and \\>60 min) Body weight and height: Self-report body weight and height Alcohol consumption: Average number of units of alcohol consumed per week",{"measure":55,"description":56,"timeFrame":12},"Changes in angina symptoms","Changes in angina symptoms by randomization group measured by the Seattle Angina Questionnaire. The Seattle Angina Questionnaire is a validated 7-item questionnaire assessing angina frequency, symptom burden, physical limitation, and quality of life related to coronary artery disease. The summary score ranges from 0-100 and higher scores indicate better functioning, fewer physical limitations, less frequent angina, and a higher quality of life.",{"measure":58,"description":59,"timeFrame":12},"Origin of recurrent ischemic events","Risk of recurrent ischemic events by origin (previously treated PCI lesion or progression of CAD in non-target segments) and by randomization group. Information will be obtained from hospital medical records upon hospitalization for a reccurent event (a subgroup assessed by FFR\u002FOCT) and from registry data (The Norwegian Registry of Invasive Cardiology and The Norwegian Patient Registry).",{"measure":61,"description":62,"timeFrame":12},"Patient-reported anxiety","Changes in patient-reported anxiety by randomization group using the Generalized Anxiety Disorder-2 (GAD-2) questionnaire. The total score ranges from 0-6 and a score of 3 or higher is considered a positive screen for anxiety",{"measure":64,"description":65,"timeFrame":12},"Patient reported depression","Changes in patient reported depression by randomization group measured by the Patient Health Questionnaire-2 (PHQ-2). Total score ranges from 0 to 6 and a score of 3 or higher is considered a positive screen for depression.",{"measure":67,"description":68,"timeFrame":12},"Patient-reported sleep disturbances","Changes in patient reported sleep disturbance by randomization group measured by Bergen Insomnia Scale (BIS). BIS is a validated questionnaire used to assess insomnia symptoms and sleep difficulties based on diagnostic criteria for insomnia, including sleep onset, sleep maintenance, early awakening, and daytime impairment. The Bergen Insomnia Scale (BIS) has a minimum score of 0, a maximum score of 42, and a diagnostic cutoff requiring a score of 3 or higher on at least one of the first four items (nighttime symptoms) combined with 3 or higher on at least one of the last two items (daytime consequences\u002Fdissatisfaction).",{"allocation":70,"interventionModel":71,"interventionModelDescription":72,"primaryPurpose":73,"observationalModel":72,"timePerspective":72,"maskingInfo":74},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":75,"maskingDescription":76,"whoMasked":77},"SINGLE","Blinded end-point commitee",[78],"OUTCOMES_ASSESSOR",[80,86],{"label":81,"type":82,"description":83,"interventionNames":84},"Aspirin discontinuation","EXPERIMENTAL","Patients in the intervention group will be randomized to discontinuing aspirin treatment. The drug will be discontinued from their medical list. All participants will receive lifestyle advice and appropriate follow-up, as recommended.",[85],"Drug: Discontinuation of aspirin (ATC-code B01AC06 and N02BA01)",{"label":87,"type":88,"description":89,"interventionNames":72},"Aspirin continuation (ATC-codes B01AC06 and N02BA01)","NO_INTERVENTION","Patients will be randomized to continuation of of low-dose oral aspirin (Anatomical Therapeutic Chemical codes B01AC06 and N02BA01) at a daily dose of ≤150 mg (usual care, no intervention). All participants will receive lifestyle advice and appropriate follow-up, as recommended.",[91],{"type":92,"name":93,"description":94,"armGroupLabels":95,"otherNames":72},"DRUG","Discontinuation of aspirin (ATC-code B01AC06 and N02BA01)","Patients will be randomized open-label 1:1 to either continuation of low-dose oral aspirin (Anatomical Therapeutic Chemical codes B01AC06 and N02BA01) at a daily dose of ≤150 mg (no intervention group) or discontinuation of aspirin therapy (intervention group). If the patient is randomized to discontinuing aspirin the treatment will be discontinued from their medical list. All participants will receive lifestyle advice and appropriate follow-up, as recommended.",[81],[97],{"name":98,"affiliation":99,"role":100},"John Munkhaugen, MD, PhD","Vestre Viken HF","PRINCIPAL_INVESTIGATOR",[102,106],{"name":98,"role":103,"phone":104,"phoneExt":72,"email":105},"CONTACT","+47 97524194","johmun@vestreviken.no",{"name":107,"role":103,"phone":108,"phoneExt":72,"email":109},"Ingrid Engebretsen, PhD","+4794406413","engebi@vestreviken.no",[111,128,142,156,165,179,190,204,218],{"facility":112,"status":72,"city":113,"state":72,"zip":114,"country":115,"countryCode":116,"cosmosGeoPoint":117,"geoPoint":122,"contacts":123},"Sørlandet Hospital Trust Arendal","Arendal","4838","Norway","NO",{"type":118,"coordinates":119},"Point",[120,121],8.77253,58.46151,{"lat":121,"lon":120},[124],{"name":125,"role":103,"phone":126,"phoneExt":72,"email":127},"Jarle Jortveit, MD, PhD","+47 99 45 07 14","jarle.jortveit@gmail.com",{"facility":129,"status":72,"city":130,"state":72,"zip":131,"country":115,"countryCode":116,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Haukeland University Hospital","Bergen","5009",{"type":118,"coordinates":133},[134,135],5.32415,60.39299,{"lat":135,"lon":134},[138],{"name":139,"role":103,"phone":140,"phoneExt":72,"email":141},"Erlend Eriksen, MD, PhD","+47 924 01 107","erlend.eriksen@helse-bergen.no",{"facility":143,"status":72,"city":144,"state":72,"zip":145,"country":115,"countryCode":116,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"Drammen hospital","Drammen","3004",{"type":118,"coordinates":147},[148,149],10.20449,59.74389,{"lat":149,"lon":148},[152],{"name":153,"role":103,"phone":154,"phoneExt":72,"email":155},"Elise Sverre, MD, PhD","+4799020329","elise.christine.bjorkholen.sverre@vestreviken.no",{"facility":157,"status":72,"city":158,"state":72,"zip":159,"country":115,"countryCode":116,"cosmosGeoPoint":72,"geoPoint":72,"contacts":160},"Akershus University Hospital","Lørenskog","1478",[161],{"name":162,"role":103,"phone":163,"phoneExt":72,"email":164},"Henrik Schirmer, MD, PhD","+47 99 26 43 38","henrik.schirmer@medisin.uio.no",{"facility":166,"status":72,"city":167,"state":72,"zip":168,"country":115,"countryCode":116,"cosmosGeoPoint":169,"geoPoint":173,"contacts":174},"Oslo University Hospital Rikshospitalet","Oslo","0372",{"type":118,"coordinates":170},[171,172],10.74609,59.91273,{"lat":172,"lon":171},[175],{"name":176,"role":103,"phone":177,"phoneExt":72,"email":178},"Peder Peder Myhre, MD, PhD","+47 93 02 56 44","pedmyh@ous-hf.no",{"facility":180,"status":72,"city":167,"state":72,"zip":181,"country":115,"countryCode":116,"cosmosGeoPoint":182,"geoPoint":184,"contacts":185},"Oslo University Hospital Ullevaal","0450",{"type":118,"coordinates":183},[171,172],{"lat":172,"lon":171},[186],{"name":187,"role":103,"phone":188,"phoneExt":72,"email":189},"Sigrun Halvorsen, MD, PhD","+4791317460","sigrun.halvorsen@medisin.uio.no",{"facility":191,"status":72,"city":192,"state":72,"zip":193,"country":115,"countryCode":116,"cosmosGeoPoint":194,"geoPoint":198,"contacts":199},"Stavanger Universty Hospital","Stavanger","4068",{"type":118,"coordinates":195},[196,197],5.73332,58.97005,{"lat":197,"lon":196},[200],{"name":201,"role":103,"phone":202,"phoneExt":72,"email":203},"Alf Inge Larsen, MD, PhD","+47 958 89 896","alf.inge.larsen@sus.no",{"facility":205,"status":72,"city":206,"state":72,"zip":207,"country":115,"countryCode":116,"cosmosGeoPoint":208,"geoPoint":212,"contacts":213},"University Hospital of North Norway Tromsø","Tromsø","9019",{"type":118,"coordinates":209},[210,211],18.95508,69.6489,{"lat":211,"lon":210},[214],{"name":215,"role":103,"phone":216,"phoneExt":72,"email":217},"Kristina Fladseth, MD, PhD","+47 98412227","kristina.fladseth@gmail.com",{"facility":219,"status":72,"city":220,"state":72,"zip":221,"country":115,"countryCode":116,"cosmosGeoPoint":222,"geoPoint":226,"contacts":227},"St. Olavs Hospital","Trondheim","7030",{"type":118,"coordinates":223},[224,225],10.39506,63.43049,{"lat":225,"lon":224},[228],{"name":229,"role":103,"phone":230,"phoneExt":72,"email":231},"Erik Madssen, MD, PhD","+4795927169","Erik.Madssen@stolav.no",{"type":233,"investigatorFullName":72,"investigatorTitle":72,"investigatorAffiliation":72,"oldNameTitle":72,"oldOrganization":72},"SPONSOR",[235,238,240,243,245,247,248,250,252,254,256,258],{"name":236,"class":237},"Oslo Universitetssykehus Hospital Trust","UNKNOWN",{"name":239,"class":237},"Akershus University Hospital Trust",{"name":241,"class":242},"Sorlandet Hospital HF","OTHER_GOV",{"name":244,"class":242},"Helse Stavanger HF",{"name":246,"class":6},"Helse-Bergen HF",{"name":219,"class":6},{"name":249,"class":6},"Norwegian Health Association",{"name":251,"class":237},"Landsforeningen for hjerte og lungesyke (LHL)",{"name":253,"class":6},"Bispebjerg Hospital",{"name":255,"class":6},"Odense University Hospital",{"name":257,"class":6},"University of Oslo",{"name":259,"class":6},"University Hospital of North Norway","100658704","phase-4-reconsidering-long-term-apirin-in-the-elderly-in-secondary-prevention-of-coronary-artery-disease-norway-100658704",false,"NCT07854795","Reconsidering Long-Term Apirin in the Elderly in Secondary Prevention of Coronary Artery Disease Norway","REconsidering Long-TErm ASpirin in the Elderly in Secondary Prevention of Coronary Artery Disease (RELEASE) Norway: A Randomised, Registry-based Trial","RELEASE-Norway","Inclusion Criteria:\n\n* Age ≥65 years at randomization treated with low-dose (≤150 mg\u002Fday) aspirin\n* An ACS event treated with PCI 2-8 years prior to randomisation and no ischemic cardiovascular event (MI or stroke) or any coronary revascularization procedure (PCI\u002Fcoronary artery bypass grafting) since index event\n* Signed informed consent and expected cooperation according to ICH\u002FGCP and national\u002Flocal regulations\n\nExclusion Criteria:\n\n* Indication for antiplatelet treatment other than secondary prevention of CAD (i.e. haematological diseases, stroke, PAD)\n* Active treatment with or indication for anti-coagulant or P2Y12-inhibitor therapy\n* Left main stenosis or any history of stent thrombosis, or other contraindications to discontinuation of aspirin according to treating physician\n* Any condition (e.g. drug\u002Falcohol abuse, dementia) or situation, that in the investigator's opinion could put the subject at signifi-cant risk directly related to the randomized aspirin strategy, confound the results, interfere significantly with participation, or render informed consent unfeasible. Investigators are explicitly encouraged not to exclude patients solely due to advanced age, frailty or polypharmacy if equipoise exists regarding aspirin continuation vs. discontinuation and informed consent is feasible.\n* Life expectancy \\\u003C12 months due to non-cardiac reasons or not being able to understand Norwegian or English language","ALL","65 Years",{"count":271,"type":272},7000,"ESTIMATED","INTERVENTIONAL",[275],"PHASE4","Lifelong aspirin has been a cornerstone of secondary prevention after coronary artery disease (CAD), based on trials conducted 40-50 years ago. Since then, major advances in coronary reperfusion and risk factor management have significantly improved outcomes. At the same time, aspirin is clearly associated with an increased risk of major bleeding, including intracranial haemorrhage. This raises a critical, yet unanswered question: in patients more than 2 years after a CAD event, does the benefit of continued aspirin still outweigh its bleeding risk? RELEASE-Norway is an investigator-initiated, registry-based, randomised trial with blinded endpoint assessment (PROBE design) designed to determine whether patients with chronic CAD can safely stop aspirin without losing cardiovascular protection. The trial will randomise 7,000 patients from all major hospitals in Norway. Together with a similar trial (RELEASE-Denmark, n≈7,000) planned in Denmark, the study will provide definitive evidence on the long-term net clinical benefit versus harm of aspirin in stable CAD and most likely directly inform future guidelines and clinical practice worldwide. Imaging and PROMS sub-studies will explore clinical and psychosocial mechanisms, providing insight into treatment heterogeneity and enabling future personalised antiplatelet therapy. Additionally, a health-economic analysis will assess the cost-effectiveness of discontinuing aspirin for healthcare systems.",[278],"Coronary Arterial Disease (CAD)",[280,281,282],"RELEASE","Aspirin","PCI","NOT_YET_RECRUITING","2026-10-01",{"date":286,"type":287},"2026-10-02","ACTUAL",{"date":289,"type":272},"2027-02-01",{"date":291,"type":272},"2031-12-01",{"name":5,"class":6},9]