Colonoscopy and Antiplatelet Therapy Trial

Phase 4

Not yet recruiting

• Conditions: Coronary Arterial Disease (CAD); Peripheral Vascular Disease
• Interventions: Drug: P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel); Drug: Aspirin

• Registration Number: NCT06613191
• Lead Sponsor: Ochsner Health System

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-23
• Study First Submitted QC: 2024-09-23
• Last Update Submitted: 2024-09-23
• Study First Posted: 2024-09-25
• Last Update Posted: 2024-09-25
• Study Start: 2024-10-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
P2Y12 inhibitor only	P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)	Participants receiving a P2Y12 inhibitor only at time of the colonoscopy
Aspirin only	Aspirin	Participants receiving aspirin only at time of the colonoscopy

Primary Outcome Measures

Name	Time	Method
Primary safety endpont	7 days	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.

Trial Locations

Locations (1)

Ochsner Health; 🇺🇸 New Orleans, Louisiana, United States