[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551839":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":57,"collaborators":11,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":11,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":11,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":11,"overallStatus":44,"whyStopped":11,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"ResoTher Pharma","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"RTP-026","EXPERIMENTAL",null,[13],"Drug: RTP-026",{"label":15,"type":10,"description":11,"interventionNames":16},"Placebo",[17],"Drug: Placebo",[19,23],{"type":20,"name":9,"description":21,"armGroupLabels":22,"otherNames":11},"DRUG","Intervention is for each subject administered as three 30-minutes infusions of either A: 25μg\u002Fkg RTP-026; or B: ≥ 26μg\u002Fkg and ≤75μg\u002Fkg RTP-026; or C: A maximum of 3 x treatment dose RTP-026 as given in B;",[9],{"type":20,"name":15,"description":24,"armGroupLabels":25,"otherNames":11},"Intervention is for each subject administered as three 30-minutes infusions of placebo",[15],[27],{"name":28,"affiliation":29,"role":30},"Thomas Engstrøm, Prof. MD","Hjertecenteret, Rigshospitalet, Denmark","PRINCIPAL_INVESTIGATOR",[32,37],{"name":33,"role":34,"phone":35,"phoneExt":11,"email":36},"Irene Sandholdt","CONTACT","+45 2015 7033","isa@croxxmed.com",{"name":38,"role":34,"phone":39,"phoneExt":11,"email":40},"Samra J Sanni, PhD","+45 3120 8857","sas@resotherpharma.com",[42],{"facility":43,"status":44,"city":45,"state":11,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Hjertecenteret, Rigshospitalet","RECRUITING","Copenhagen","2100","Denmark","DK",{"type":50,"coordinates":51},"Point",[52,53],12.56553,55.67594,{"lat":53,"lon":52},[56],{"name":28,"role":34,"phone":11,"phoneExt":11,"email":11},{"type":58,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100551839","phase-2-a-study-of-rtp-026-to-assess-safety-tolerability-and-efficacy-in-patients-with-st-elevation-myocardial-infarction-stemi-100551839",false,"NCT06465303","A Study of RTP-026 to Assess Safety, Tolerability and Efficacy in Patients With ST-Elevation Myocardial Infarction (STEMI)","An Exploratory, Randomised, Double-blind, Multicentre, Placebo-controlled Study of RTP-026 to Assess Safety, Tolerability and Efficacy in Patients With ST-Elevation Myocardial Infarction (STEMI)","Inclusion Criteria:\n\n* Informed consent for participation in the study has been obtained prior to initiating any study-specific procedures\n* Men between 18-85 years of age and post-menopausal women up to 85 years of age\n* Acute onset of chest pain of \\\u003C 12 hours duration\n* STEMI as characterized on ECG by 2 mm ST elevation in 2 or more V1 through V4 leads or presumed new left bundle branch block with a minimum of 1 mm concordant ST elevation or 1 mV ST elevation in the limb lead (II, III and aVF, I, aVL) and V4-V6 or ST depression in 2 or more V1 through V4 leads indicating posterior acute myocardial infarction (AMI)\n* Eligible for primary PCI\n* NLR in the range of 7-17 at hospital admission. In patients with chest pain lasting \\> 3 - ≤ 6 hours at admission, the NLR should be in the range of 4.8-17 and for patients with chest pain lasting ≤ 3 hours at admission, the NLR should be in the range of 4.8-17, or the neutrophile count should be ≥ 9 x 10E9\u002FL, irrespective of the lymphocyte count. For STEMI patients with an anterior or anterolateral infarction, the NLR should be ≥3.\n\nExclusion Criteria:\n\n* Participation in any other study involving investigational drug(s) during the study and within 4 weeks prior to study entry\n* Previous exposure to RTP-026\n* Time from symptoms onset to primary PCI \\> 12 hours\n* Previous CABG\n* Evidence of active malignant disease\n* Ongoing treatment with immune suppressive compounds\n* Any condition that, in the view of the investigator, would suggest that the patient is unable to comply with the study protocol and procedures\n* Known contraindications to CMR\n* ORBI Risk Score \\> 12","ALL","18 Years","85 Years",{"count":70,"type":71},96,"ESTIMATED","INTERVENTIONAL",[74],"PHASE2","This is an exploratory, randomized, double-blind, multicentre, placebo-controlled study of RTP-026.\n\nThe study population will consist of men and women with documented evidence of ST-elevation myocardial infarction (STEMI) referred to primary Percutaneous Coronary Intervention (PCI).",[77],"ST Elevation Myocardial Infarction","2025-09-16",{"date":80,"type":81},"2025-09-22","ACTUAL",{"date":83,"type":81},"2024-07-16",{"date":85,"type":71},"2025-12-21",{"name":5,"class":6},1]