[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"st-elevated-myocardial-infarction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:st-elevated-myocardial-infarction":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100476995","phase-4-comparison-of-reduced-dapt-followed-by-p2y12-inhibitor-monotherapy-with-prasugrel-vs-standard-regimen-in-stemi-patients-100476995",false,"NCT05491200","Comparison Of Reduced DAPT Followed by P2Y12 Inhibitor Monotherapy With Prasugrel vs stAndard Regimen in STEMI Patients","COMPARE STEMI ONE- Comparison Of Reduced DAPT Followed by P2Y12 Inhibitor Monotherapy With Prasugrel vs stAndard Regimen in STEMI Patients Treated With OCT-guided vs aNgio-guided completE Revascularization","Inclusion Criteria:\n\nEligibility at index procedure\n\nAll STEMI patients who are planned to be treated with PCI:\n\nST segment elevation myocardial infarction\n\nChest discomfort suggestive of cardiac ischemia ≥20 min at rest with 1 of the following ECG features:\n\n* ST segment elevation ≥2 contiguous ECG leads\n* new or presumably new left bundle branch block\n\nIn patients with multivessel disease, treatment only of the culprit lesion \u002F target vessel during primary PCI is recommended.\n\nEligibility at 30-45 days\n\n* All patients who have provided informed consent\n* Compliance to DAPT with no regimen modifications (Non-adherence Academic Research Consortium 0)\n* No occurrence of significant event (such as MI, unplanned revascularisation, stent thrombosis, stroke, major vascular complication\u002Fbleeding BARC Types 3 or greater).\n* Successful revascularization: - Successful delivery and deployment of the Study device(s), with final residual stenosis of \\\u003C30% (visually) for all target lesions.\n* Complete revascularization performed when more than 1 significant lesion, during the index procedure or in staged procedure(s) occurring within 15 days from the index procedure. Physiologic assessment highly recommended for lesions with stenosis between 50% and 90%.\n\nExclusion criteria\n\n* Patients on oral anticoagulation\n* Contraindication to P2Y12 inhibitors and\u002For to Cardioaspirin or to any of the excipients (hypersensitivity, history of any stroke or transient ischemic attack within the last 12 months, active bleeding or haemorrhagic diathesis, fibrin-specific fibrinolytic therapy less than 24 h before randomization, severe hepatic dysfunction (Child-Pugh C), history of asthma induced by the administration of salicylates or substances with a similar action, notably non-steroidal anti-inflammatory medicines, history of gastrointestinal perforation or acute gastrointestinal ulcers, severe cardiac failure (NYHA grade III or IV), combination with methotrexate at doses of 15 mg\u002Fweek or more).\n* Patients who have received P2Y12 inhibitors other than Prasugrel in the ambulance (Ticagrelor or Clopidogrel loading dose) or are already on P2Y12 inhibitors, may be enrolled in the protocol, provided that the Prasugrel loading dose is administered at admission, according to current guidelines recommendations (see section 5.2.2).\n* Concomitant oral or i.v. therapy with strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, grapefruit juice \\>1L\u002Fday), CYP3A substrates with narrow therapeutic indices (e.g., cyclosporine, quinidine), or strong CYP3A inducers (e.g., rifampin), - rifampicin, phenytoin, carbamazepine, dexamethason, phenobarbital\n* Platelet count \\\u003C100.000\u002FμL at the time of screening\n* Anemia (hemoglobin \\\u003C10 g\u002FdL) at the time of screening\n* Comorbidities associated with life expectancy \\\u003C1 year\n* Pregnancy, giving birth within the last 90 days, or lactation (see appendix III for women of childbearing potential)\n* PCI indication for stent thrombosis or previous history of definite stent thrombosis\n* Non-deferrable major surgery on DAPT after PCI\n* Cardiogenic shock\n* Out of hospital cardiac arrest (OHCA) unless survivors of ventricular arrythmia with prompt return of spontaneous circulation (ROSC)\n* Patients with severe renal impairment: creatinine clearance ≤30 ml\u002Fmin\u002F1.73 m2 (as calculated by MDRD formula for estimated GFR).\n* Patients participating in another interventional (device of drug trial) within the previous 12 months or patients to whom an investigational drug was administered in the 30 days prior to screening, or 5 half-lives of the study drug, whichever is longer.\n* No informed consent","ALL",{"count":18,"type":19},1656,"ESTIMATED","INTERVENTIONAL",[22],"PHASE4","The study is a multi-centre, Open-label, Randomized Controlled, 1:1 trial comparing Prasugrel-based short DAPT (30-45 days) followed by Prasugrel monotherapy versus standard DAPT regimen in STEMI patients in terms of safety and efficacy endpoints.\n\nIn the subgroup of STEMI patients with MVD, a sub-randomization will allow a comparison between a complete revascularization OCT-guided versus complete revascularization angiography-guided stent in terms of efficacy and safety endpoints.",[25,26],"ST Elevated Myocardial Infarction","Dual Antiplatelet Therapy","RECRUITING","2026-06-30",{"date":30,"type":31},"2026-07-02","ACTUAL",{"date":33,"type":31},"2022-07-22",{"date":35,"type":19},"2029-08-01",{"name":37,"class":38},"Research Maatschap Cardiologen Rotterdam Zuid","OTHER",27,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":20,"phases":51,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100455503","phase-2-rituximab-in-patients-with-st-elevation-myocardial-infarction-100455503","NCT05211401","Rituximab in Patients With ST-elevation Myocardial Infarction","Rituximab in Patients With ST-elevation Myocardial Infarction: A Phase 2 Placebo-controlled Randomized Clinical Trial: RITA-MI 2","RITA-MI2","Inclusion Criteria:\n\n* Age ≥ 18 years with no upper limit (women must be either postmenopausal defined as being amenorrhoeic for greater than 2 years with an appropriate clinical profile, e.g. age appropriate (\\>55 years old), history of vasomotor symptoms) or having documented hysterectomy and\u002For bilateral oophorectomy) ;\n* Clinical evidence at presentation of anterior ST-elevation myocardial infarction (STEMI) defined as symptoms suggestive of acute myocardial ischemia, an electrocardiogram showing ST-segment elevation ≥2 mm in ≥2 contiguous leads in V1 to V4;\n* Complete occlusion (i.e. TIMI flow 0-1) of proximal or mid left anterior descending (LAD) coronary artery on urgent angiography interpreted as the infarct-related artery (IRA);\n* Onset of worse symptoms within 48 hours before primary PCI;\n* Patients with neutrophils \\>1.5 x 109\u002FL at the moment of admission\n* Patients with platelet counts \\>75 x 109 \u002FL at the moment of admission\n* Plan to provide primary percutaneous angioplasty (PPCI) for the patient within 2 hours of ECG diagnosis;\n* Ability to start infusion of rituximab within 3 hours of PPCI ;\n* Written informed consent.\n\nExclusion Criteria:\n\nExclusion Criteria :\n\n* History of previous MI;\n* Presentation with cardiac arrest;\n* Cardiogenic shock (defined as systolic blood pressure \\\u003C90 mmHg for \\>30minutes, or necessitating vasopressors to achieve a blood pressure ≥90 mmHg);\n* Cardiac electrical instability (defined as complete heart block needing temporary pacing or any tachyarrhythmia needing cardioversion);\n* Patients with Killip class III heart failure;\n* History of severe chronic renal failure (define as stage 4 (GFR = 15-29 mL\u002Fmin) or worse);\n* History of hepatitis B, HIV or tuberculosis;\n* Patient positive for point of care bedside test of Ag HBs;\n* Severe, progressive infections documented;\n* Active COVID-19 infection or COVID-19 infection within 3 months;\n* Patient with documented severe immune deficiency;\n* Presence, or history in ≤ five years, of an ongoing cancer, (except in situ cancer of the cervix or basal cell carcinoma);\n* QTcF\\> 450 msecs in males, \\> 470msecs in females;\n* Any oral or intravenous immunosuppressive treatment, immune modulatory monoclonal antibodies or immunodepleting therapy at any time (inhalers and topical creams with corticosteroids are permitted);\n* Previous history of major organ transplant including renal transplant;\n* Known hypersensitivity to the active substance of rituximab or to proteins of murine origin, or to any of the other excipients;\n* Any contraindications to any of the rituximab premedication drugs;\n* Contraindications to injectable Polaramine:\n\nRisk of closed-angle glaucoma, Risk of urinary retention linked to urethro-prostatic disorders;\n\n* Expected need for vaccination with a live attenuated vaccine during the study, including incomplete vaccination courses (in case, life, attenuated vaccine must be administered at least 30 days before inclusion in study);\n* Absence of a complete COVID-19 vaccination scheme (including recovery from documented COVID infection) as approved at the time of enrollment in the country where the patient is recruited;\n* Any obvious contraindications for MRI or conditions which will impede image acquisition for example:\n\nSevere claustrophobia\n\nNon-MRI compatible permanent pacemaker\n\nPatients who have a metallic foreign body (metal silver) in their eye, or who have an aneurysm clip in their brain\n\nPatients who have had metallic devices placed in their back\n\nKnown hypersensitivity to imaging products (gadoteric acid, meglumin or any drug containing gadolinium)\n\n* Known hepatic failure;\n* Previous history of progressive multifocal leukoencephalopathy;\n* Inclusion in other interventional drug study within the previous 3 months;\n* Inability to comply with study procedures;\n* Patients under guardianship or curatorship.","18 Years",{"count":50,"type":19},372,[52],"PHASE2","The main objective is to compare the effect of a single injection of two doses of rituximab versus placebo on 6 months left ventricular systolic function, using CMR, in patients who have had an acute anterior STEMI. Following the sponsor's decision to stop enrolment in the 200 mg arm, the primary objective of the study is to evaluate the efficacy of a single 1000 mg dose of rituximab versus placebo.\n\nThe primary endpoint is the left ventricular ejection fraction (LVEF) by CMR at 6 months.",[25],[56,57,58,59,60,61],"Acute Myocardial Infarction","Anterior STEMI","Rituximab","Left ventricular systolic function","CMR","Cardiac remodelling","2026-04-17",{"date":64,"type":31},"2026-04-22",{"date":66,"type":31},"2022-06-01",{"date":68,"type":19},"2028-05",{"name":70,"class":38},"Assistance Publique - Hôpitaux de Paris",1]