Colonoscopy and Antiplatelet Therapy Trial

Launched by OCHSNER HEALTH SYSTEM · Sep 23, 2024

Keywords

ClinConnect Summary

The Colonoscopy and Antiplatelet Therapy Trial is a research study designed to find out how stopping certain heart medications affects bleeding during and after a colonoscopy, which is a procedure used to examine the colon. Patients who have heart conditions, such as coronary artery disease or peripheral vascular disease and are taking a combination of aspirin and another medication called a P2Y12 inhibitor (like clopidogrel, prasugrel, or ticagrelor), are at a higher risk of bleeding during this procedure. This trial will compare the bleeding risk between patients who only take aspirin and those who only take a P2Y12 inhibitor by randomly asking participants to stop one of these medications a week before their colonoscopy.

To be eligible for this study, participants must be at least 45 years old and have stable heart conditions without recent changes in their medications. They also need to be scheduled for an outpatient colonoscopy. Unfortunately, individuals with certain recent heart events, serious heart failure, or specific complications are not eligible to participate. If you decide to join this trial, you will help researchers better understand how to manage medications for patients undergoing colonoscopy, ultimately aiming to reduce the risk of bleeding during the procedure.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 45 years
• • 2. 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.
• • 3. 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"
• • 4. Scheduled for elective screening or surveillance outpatient colonoscopy
• Exclusion Criteria:
• • 1. Coronary intervention (PCI or CABG) less than 90 days prior to randomization
• • 2. ACS event in less than 90 days prior to randomization
• • 3. Transient ischemic attack (TIA) and/or stroke event in less than 90 days prior to randomization
• • 4. Acute limb ischemia and/or amputation in less than 90 days prior to randomization
• • 5. Post cardiac valve replacement (either percutaneous or surgical)
• 6. High cardiovascular risk:
• • 1. Patients with CCS class 4 angina
• • 2. Hospitalized with ACS within 1 month prior to randomization
• • 3. Patients undergoing PCI or CABG within the 3 months prior to randomization
• • 7. Patients on left ventricular assist device (LVAD) or post cardiac transplantation
• • 8. Patients with NYHA class 3 or 4 heart failure
• • 9. Any condition requiring treatment requires chronic use of an anticoagulant.
• • 10. Chronic kidney disease Stage 5 (with or without dialysis)
• • 11. Liver cirrhosis with platelet count \< 50,000/ mm3 and/or INR \>1.4
• • 12. Hematocrit \< 30% and hemoglobin \< 10 mg/dL
• • 13. Emergent or inpatient Colonoscopy