NCT06613191

Colonoscopy and Antiplatelet Therapy Trial

P2Y12 Inhibitor Versus Aspirin Monotherapy in Patients Undergoing Elective Screening and Surveillance Colonoscopy

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Ochsner Health System · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Arterial Disease (CAD)
• Peripheral Vascular Disease

Interventions

Type	Name	Description
DRUG	Aspirin	Participant will be on aspirin alone or P2Y12 inhibitor alone
DRUG	P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)	Participant will be taking either P2Y12 inhibitor at time of colonoscopy

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-12-31
• Completion: 2026-06-30
• First posted: 2024-09-25
• Last updated: 2024-09-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study