[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100529561":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":50,"locations":30,"responsibleParty":60,"collaborators":30,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":30,"enrollmentInfo":72,"targetDuration":30,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":30,"overallStatus":81,"whyStopped":30,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":30},{"fullName":5,"class":6},"Assistance Publique Hopitaux De Marseille","OTHER",[8,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Long dual Aspirin\u002FClopidogrel therapy","ACTIVE_COMPARATOR","Patients will be treated with usual long dual antiplatelet aggregation for 6 to 12 months",[13,14,15,16,17],"Procedure: Percutaneous coronary intervention","Other: Long dual Aspirin\u002FClopidogrel therapy","Other: Follow-up visit at 1 month","Other: Follow-up visit at 6 months","Other: Follow-up visit at 12 months",{"label":19,"type":20,"description":21,"interventionNames":22},"Short dual Aspirin\u002FClopidogrel therapy","EXPERIMENTAL","Patients will be treated with short dual antiplatelet aggregation for 1month",[13,23,15],"Drug: Short dual Aspirin\u002FClopidogrel therapy",[25,31,35,38,42,46],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"PROCEDURE","Percutaneous coronary intervention","A percutaneous coronary intervention for chronic total occlusion lesion with at least one implanted coronary stent will be performed as part of routine care.",[9,19],null,{"type":32,"name":19,"description":33,"armGroupLabels":34,"otherNames":30},"DRUG","Aspirin will be prescribed as part of the patient's normal course of care, according to current recommendations. The second antiplatelet agent will be clopidogrel, the duration of which will vary according to the randomization group of each patient included. Patients will be treated for 1 month.",[19],{"type":6,"name":9,"description":36,"armGroupLabels":37,"otherNames":30},"Aspirin will be prescribed as part of the patient's normal course of care, according to current recommendations. The second antiplatelet agent will be clopidogrel, the duration of which will vary according to the randomization group of each patient included. Patients will be treated for 6 to 12 months.",[9],{"type":6,"name":39,"description":40,"armGroupLabels":41,"otherNames":30},"Follow-up visit at 1 month","At 1 month following the inclusion a visit or a phone call with the referring cardiologist will be organized.",[9,19],{"type":6,"name":43,"description":44,"armGroupLabels":45,"otherNames":30},"Follow-up visit at 6 months","At 6 months following the inclusion a visit or a phone call with the referring cardiologist will be organized.",[9],{"type":6,"name":47,"description":48,"armGroupLabels":49,"otherNames":30},"Follow-up visit at 12 months","At 12 months following the inclusion a visit or a phone call with the referring cardiologist will be organized.",[9],[51,56],{"name":52,"role":53,"phone":54,"phoneExt":30,"email":55},"Pierre DEHARO, Dr","CONTACT","04 91 48 59 97","pierre.deharo@ap-hm.fr",{"name":57,"role":53,"phone":58,"phoneExt":30,"email":59},"Alexandra GIULIANI","04 91 48 28 70","alexandra.giuliani@ap-hm.fr",{"type":61,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100529561","antiplatelet-therapy-after-successful-percutaneous-coronary-intervention-for-chronically-occluded-coronary-artery-100529561",false,"NCT06175377","Antiplatelet Therapy After Successful Percutaneous Coronary Intervention for Chronically Occluded Coronary Artery","Antiplatelet Therapy After Successful Percutaneous Coronary Intervention for Chronically Occluded Coronary Artery: A Prospective, Multicenter, Randomized Study Comparing Two Durations of Dual Antiplatelet Therapy","DAPT-CTO","Inclusion Criteria:\n\n* Patients who underwent a successful coronary stent implantation for chronic coronary occlusion, eligible for long-term aspirin therapy and requiring a dual antiplatelet therapy\n* Affiliated to Social Security system.\n* Signature of informed consent.\n* Age \\> 18 years old.\n\nExclusion Criteria:\n\n* Dual antiplatelet therapy contra-indication\n* Patient with hypersensitivity to aspirin (or any of its excipients) and\u002For to any of the active substance or to any of the excipients of the investigational medical product used in this study (clopidogrel);\n* Patient with contraindication to aspirin and\u002For clopidogrel.\n* No coronary stent implanted\n* Age \\\u003C 18years\n* Patient under guardianship\n* Pregnancy or breast feeding\n* Prasugrel or ticagrelor use","ALL","18 Years",{"count":73,"type":74},660,"ESTIMATED","INTERVENTIONAL",[77],"NA","Coronary arteries are in charge of oxygen supply for the myocardium. When coronary arteries develop stenosis the coronary blood flow (i.e. oxygen flow) is reduced. Chronic total occlusion (CTO) is the extreme evolution of a coronary stenosis, which ends up to a total vessel closure.\n\nPercutaneous coronary intervention (PCI) is the main treatment for chronic occlusions. The principle of this treatment is to implant a stent covering the whole segment of occlusion and allowing the blood to perfuse the myocardium antegradely and not retrogradely via the collateral(s). This angioplasty and stent implantation requires a dual antiplatelet therapy (aspirin associated with clopidogrel) to prevent a new thrombosis within the newly placed coronary stent.\n\nFollowing the development of coronary stent (and particularly drug eluting coronary stent) new thrombosis within the implanted coronary scaffold have emerged. Dual antiplatelet therapy (DAPT) (compared to single antiplatelet therapy or anticoagulant) and initially prolonged DAPT (12 months) has offered a preventive treatment for stent thrombosis after PCI.\n\nPCI treatment for CTOs continues to increase in France and around the world, while no dedicated study has been proposed so far regarding DAPT duration. Therefore, the general European recommendations for DAPT in chronic coronary syndrome management guidelines should be applied even though the CTO poses specific technical challenges (long and multiple stenting length for example). Even if 6 months DAPT is recommended as routine duration in chronic coronary syndrome (CCS), longer DAPT (12 months) is possible in this setting. However, the optimal duration of DAPT is not clearly demonstrated on an individual basis and each physician must adapt the DAPT duration for each single patient. A so called \"ischemic \u002F bleeding balance \"guides the duration of DAPT.\n\nThis study would be the first randomized protocol to clarify the efficacy and safety of a shorter DAPT duration in the specific context of CTO PCI. It is conceivable that the technical advances which have made it possible to reduce the duration of DAPT to up to 1 month, in the cases of patients at high risk of bleeding for example, could be applicable to CTO PCI. Therefore, reducing the DAPT to 1 month, in the setting of CTO PCI, could reduce the haemorrhagic risk which should be proportional to the duration of the DAPT. Moreover, the invesitgators will evaluate the safety of short DAPT in terms of ischemic events during follow-up.",[80],"Chronic Total Occlusion","NOT_YET_RECRUITING","2023-12-15",{"date":84,"type":85},"2023-12-18","ACTUAL",{"date":87,"type":74},"2024-03-30",{"date":89,"type":74},"2027-09-30",{"name":5,"class":6}]