Colonoscopy and Antiplatelet Therapy Trial
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age45+
SponsorOchsner Health System
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Acute limb ischemia and/or amputation in less than 90 days prior to randomization
Trial design
Treatments tested in this trial
- Aspirin
- P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov