Colonoscopy and Antiplatelet Therapy Trial

Part of paid clinical trials in New Orleans, Louisiana.

Sponsor
Ochsner Health System
Study ID
NCT06613191
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Coronary Arterial Disease (CAD)
  • Peripheral Vascular Disease

Eligibility Criteria

Sex
ALL
Age
45 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 1, 2024
Status verified
Sep 2024
Primary completion
Dec 31, 2025
Completion
Jun 30, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Aspirin only
    Participants receiving aspirin only at time of the colonoscopy
  • Experimental: P2Y12 inhibitor only
    Participants receiving a P2Y12 inhibitor only at time of the colonoscopy

Primary Outcome Measure

Primary safety endpont [ Time Frame: 7 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ochsner HealthNew OrleansLouisiana70121
Mark B Effron, MD
[email protected]
504-842-2421
Janak Shah, MD
[email protected]
504-842-4015
Mark B Effron, MD

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By research site
Ochsner Health· New Orleans, LA

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