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NCT06613191 · ClinicalTrials.gov registry record · Phase 4
Colonoscopy and Antiplatelet Therapy Trial
A Phase 4 study, sponsored by Ochsner Health System.
- Not yet
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
NCT06613191: Clinical Trial Phase 4 study, sponsored by Ochsner Health System.
NCT06613191 is a Phase 4 study that has not yet begun recruiting, run by Ochsner Health System. The registered enrollment target is 100 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06613191, a Phase 4 study, has not yet begun recruiting, sponsored by Ochsner Health System.
- NOT YET RECRUITING
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
Study 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.
Primary Outcome
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 furt
Interventions
- DRUG Aspirin
- DRUG P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-10-01 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 4 |
What is known before NCT06613191 opens enrollment
NCT06613191 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 2 interventions - of which Aspirin is the first listed.
NCT06613191 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06613191 about?
NCT06613191 is a clinical study titled "Colonoscopy and Antiplatelet Therapy Trial". 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...
What is the current status of trial NCT06613191?
This trial is currently not yet recruiting. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2024-10-01. Estimated completion is 2026-06-30.
What interventions are being tested in trial NCT06613191?
The interventions under investigation include: Aspirin (DRUG), P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel) (DRUG).
Who is sponsoring clinical trial NCT06613191?
This trial is sponsored by Ochsner Health System, which has 29 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06613191's enrollment target sits among peer trials
100 770th of 2000 higher than 1,148 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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