Colonoscopy and Antiplatelet Therapy Trial
Launched by OCHSNER HEALTH SYSTEM · Sep 23, 2024
Trial Information
Current as of March 11, 2025
Not yet recruiting
Keywords
ClinConnect Summary
No description provided
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
About Ochsner Health System
Ochsner Health System is a leading healthcare provider based in Louisiana, renowned for its commitment to innovative clinical research and patient-centered care. As a prominent sponsor of clinical trials, Ochsner leverages its extensive network of hospitals, specialty clinics, and research facilities to advance medical knowledge and improve treatment outcomes across various therapeutic areas. With a focus on enhancing patient health and well-being, Ochsner integrates cutting-edge research with clinical practice, offering unique opportunities for collaboration and participation in transformative studies that aim to address pressing health challenges.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New Orleans, Louisiana, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0