Colonoscopy and Antiplatelet Therapy Trial

NCT ID: NCT06613191

Last Updated: 2024-09-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2026-06-30

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.

Conditions

Coronary Arterial Disease (CAD); Peripheral Vascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Aspirin only

Participants receiving aspirin only at time of the colonoscopy

Group Type: ACTIVE_COMPARATOR

Aspirin

Intervention Type: DRUG

Participant will be on aspirin alone or P2Y12 inhibitor alone

P2Y12 inhibitor only

Participants receiving a P2Y12 inhibitor only at time of the colonoscopy

Group Type: EXPERIMENTAL

P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)

Intervention Type: DRUG

Participant will be taking either P2Y12 inhibitor at time of colonoscopy

Interventions

Aspirin

Participant will be on aspirin alone or P2Y12 inhibitor alone

Intervention Type: DRUG

P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)

Participant will be taking either P2Y12 inhibitor at time of colonoscopy

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ochsner Health System

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ochsner Health

New Orleans, Louisiana, United States

Countries

United States

Central Contacts

Mark B Effron, MD

Role: CONTACT

mark.effrob@ochsner.org

(504) 842-2421

Facility Contacts

Mark B Effron, MD

Role: primary

mark.effron@ochsner.org

504-842-2421

Janak Shah, MD

Role: backup

janak.shah@ochsner.org

504-842-4015

Mark B Effron, MD

Role: backup

Other Identifiers

INVEST CVD

Identifier Type: OTHER

Identifier Source: secondary_id

2024.105

Identifier Type: -

Identifier Source: org_study_id