Colonoscopy and Antiplatelet Therapy Trial (CAPTT)

Ochsner Health System

Status and phase: Not yet enrolling; Phase 4

Conditions: Peripheral Vascular Disease; Coronary Arterial Disease (CAD)

Treatments: Drug: Aspirin; Drug: P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)

Study type: Interventional

Funder types: Other

Identifiers

NCT06613191

INVEST CVD (Other Identifier)

2024.105

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Aspirin only

Active Comparator group

Description:

Participants receiving aspirin only at time of the colonoscopy

Treatment:

Drug: Aspirin

P2Y12 inhibitor only

Experimental group

Description:

Participants receiving a P2Y12 inhibitor only at time of the colonoscopy

Treatment:

Drug: P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)