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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Aspirin
DrugParticipant will be on aspirin alone or P2Y12 inhibitor alone
P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)
DrugParticipant will be taking either P2Y12 inhibitor at time of colonoscopy
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Aspirin onlyActive comparator 1 intervention
Group B: P2Y12 inhibitor onlyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Primary safety endpont
Composite of: * Use of endoscopic clips post-polypectomy to control persistent intraprocedural bleeding (defined as bleeding persisting for greater than 2 minutes), * Major delayed bleeding, which was symptomatically or clinically overt and associated with an unplanned admission or readmission to hospital for rectal bleeding, * Bleeding that directly contributed to death, * Minor bleeding defined as any sign or symptom of peri-rectal bleeding that did not fit the above criteria, * Need for further intervention to control bleeding such as endoscopic, surgical, or radiological intervention, or * Bleeding causes a fall in hemoglobin ≥ 2 g/dL or leads to transfusion of whole blood or red cells.
Time frame
7 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: