Colonoscopy and Antiplatelet Therapy Trial (NCT06613191) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Colonoscopy and Antiplatelet Therapy Trial
United States100 participantsStarted 2024-10-01
Plain-language summary
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.
Who can participate
Age range45 Years
SexALL
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Inclusion criteria
✓. Age ≥ 45 years
✓. Stable patients defined as having Angina CCS (Canadian Cardiovascular Society) class 1-3 and/or Heart Failure NYHA class 1-2 without a change in guideline directed anti-ischemic or heart failure medications within 30 days prior to randomization.
✓. 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"
✓. Scheduled for elective screening or surveillance outpatient colonoscopy
Exclusion criteria
✕. Coronary intervention (PCI or CABG) less than 90 days prior to randomization
✕. ACS event in less than 90 days prior to randomization
✕. Transient ischemic attack (TIA) and/or stroke event in less than 90 days prior to randomization