Colonoscopy and Antiplatelet Therapy Trial (CAPTT)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Peripheral Vascular Disease; Coronary Arterial Disease (CAD)
• Intervention / Treatment: Drug: Aspirin; Drug: P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Mark B Effron, MD; Phone Number: (504) 842-2421; Email: mark.effrob@ochsner.org

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Health
      • Contact: Mark B Effron, MD; Phone Number: 504-842-2421; Email: mark.effron@ochsner.org
      • Contact: Janak Shah, MD; Phone Number: 504-842-4015; Email: janak.shah@ochsner.org
      • Contact: Mark B Effron, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Aspirin only; Participants receiving aspirin only at time of the colonoscopy	Drug: Aspirin; Participant will be on aspirin alone or P2Y12 inhibitor alone
Experimental: P2Y12 inhibitor only; Participants receiving a P2Y12 inhibitor only at time of the colonoscopy	Drug: P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel); Participant will be taking either P2Y12 inhibitor at time of colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary safety endpont	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.	7 days

Collaborators and Investigators

• Sponsor: Ochsner Health System

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: September 23, 2024
• First Submitted That Met QC Criteria: September 23, 2024
• First Posted (Actual): September 25, 2024

Study Record Updates

• Last Update Posted (Actual): September 25, 2024
• Last Update Submitted That Met QC Criteria: September 23, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Colonoscopy; Antiplatelet therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Aspirin; Ticagrelor; Clopidogrel; Prasugrel Hydrochloride
• Other Study ID Numbers: 2024.105; INVEST CVD (Other Identifier: Ochsner Clinic Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No