[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563209":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":60,"collaborators":26,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":26,"enrollmentInfo":72,"targetDuration":26,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":85,"whyStopped":26,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Ochsner Health System","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Aspirin only","ACTIVE_COMPARATOR","Participants receiving aspirin only at time of the colonoscopy",[13],"Drug: Aspirin",{"label":15,"type":16,"description":17,"interventionNames":18},"P2Y12 inhibitor only","EXPERIMENTAL","Participants receiving a P2Y12 inhibitor only at time of the colonoscopy",[19],"Drug: P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Aspirin","Participant will be on aspirin alone or P2Y12 inhibitor alone",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)","Participant will be taking either P2Y12 inhibitor at time of colonoscopy",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Mark B Effron, MD","CONTACT","(504) 842-2421","mark.effrob@ochsner.org",[38],{"facility":39,"status":26,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Ochsner Health","New Orleans","Louisiana","70121","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-90.07507,29.95465,{"lat":49,"lon":48},[52,55,59],{"name":33,"role":34,"phone":53,"phoneExt":26,"email":54},"504-842-2421","mark.effron@ochsner.org",{"name":56,"role":34,"phone":57,"phoneExt":26,"email":58},"Janak Shah, MD","504-842-4015","janak.shah@ochsner.org",{"name":33,"role":34,"phone":26,"phoneExt":26,"email":26},{"type":61,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100563209","phase-4-colonoscopy-and-antiplatelet-therapy-trial-100563209",false,"NCT06613191","Colonoscopy and Antiplatelet Therapy Trial","P2Y12 Inhibitor Versus Aspirin Monotherapy in Patients Undergoing Elective Screening and Surveillance Colonoscopy","CAPTT","Inclusion Criteria:\n\n1. Age ≥ 45 years\n2. Stable patients defined as having Angina CCS (Canadian Cardiovascular Society) class 1-3 and\u002For Heart Failure NYHA class 1-2 without a change in guideline directed anti-ischemic or heart failure medications within 30 days prior to randomization.\n3. Patients with cardiovascular disease defined as coronary artery disease, cerebrovascular disease or peripheral vascular disease taking DAPT (defined as aspirin plus a P2Y12 inhibitor). The decision to use DAPT in this patient will be made by the managing physician(s) before recruitment for this study. Consider replacing last statement with \"As directed by their physician prior to recruitment into this study\"\n4. Scheduled for elective screening or surveillance outpatient colonoscopy\n\nExclusion Criteria:\n\n1. Coronary intervention (PCI or CABG) less than 90 days prior to randomization\n2. ACS event in less than 90 days prior to randomization\n3. Transient ischemic attack (TIA) and\u002For stroke event in less than 90 days prior to randomization\n4. Acute limb ischemia and\u002For amputation in less than 90 days prior to randomization\n5. Post cardiac valve replacement (either percutaneous or surgical)\n6. High cardiovascular risk:\n\n   1. Patients with CCS class 4 angina\n   2. Hospitalized with ACS within 1 month prior to randomization\n   3. Patients undergoing PCI or CABG within the 3 months prior to randomization\n7. Patients on left ventricular assist device (LVAD) or post cardiac transplantation\n8. Patients with NYHA class 3 or 4 heart failure\n9. Any condition requiring treatment requires chronic use of an anticoagulant.\n10. Chronic kidney disease Stage 5 (with or without dialysis)\n11. Liver cirrhosis with platelet count \\< 50,000\u002F mm3 and\u002For INR \\>1.4\n12. Hematocrit \\< 30% and hemoglobin \\< 10 mg\u002FdL\n13. Emergent or inpatient Colonoscopy","ALL","45 Years",{"count":73,"type":74},100,"ESTIMATED","INTERVENTIONAL",[77],"PHASE4","Patients on dual antiplatelet therapy )aspirin plus a P2Y12 inhibitor \\[clopidogrel, prasugrel, or ticagrelor\\]) undergoing screening or surveilance colonoscopy are at increased risk for bleeding from the procedure. Patients are ussually asked to stop the P2Y12 inhibitor for the procedure. Currently, recommendation is that patients only on a P2Y12 inhibitor be changes to aspirin for the procedure. This pilot study will evaluate if there is a large difference in bleeding between patients only taking aspirin compared with patients only taking a P2Y12 inhibitor. Patinets who participate will randomly be randomly asked to stop either aspirin or the P2Y12 inhibitor 1 week before the procedure. Periprocedural bleeding and bleeding after the procedure for iup to 30 days.",[80,81],"Coronary Arterial Disease (CAD)","Peripheral Vascular Disease",[83,84],"Colonoscopy","Antiplatelet therapy","NOT_YET_RECRUITING","2024-09-23",{"date":88,"type":89},"2024-09-25","ACTUAL",{"date":91,"type":74},"2024-10-01",{"date":93,"type":74},"2026-06-30",{"name":5,"class":6},1]