Colonoscopy and Antiplatelet Therapy Trial

NCT06613191 | Not Yet Recruiting Phase 4 FDA Drug

• 2 other identifiers: 2024.105INVEST CVD
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Colonoscopy; Antiplatelet therapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Aspirin only

ACTIVE COMPARATOR

Participants receiving aspirin only at time of the colonoscopy

Drug: Aspirin

P2Y12 inhibitor only

EXPERIMENTAL

Participants receiving a P2Y12 inhibitor only at time of the colonoscopy

Drug: P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)

Interventions

Aspirin DRUG

Participant will be on aspirin alone or P2Y12 inhibitor alone

Aspirin only

P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel) DRUG

Participant will be taking either P2Y12 inhibitor at time of colonoscopy

P2Y12 inhibitor only

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 45 years
• 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.
• 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"
• Scheduled for elective screening or surveillance outpatient colonoscopy

You may not qualify if:

• Coronary intervention (PCI or CABG) less than 90 days prior to randomization
• ACS event in less than 90 days prior to randomization
• Transient ischemic attack (TIA) and/or stroke event in less than 90 days prior to randomization
• Acute limb ischemia and/or amputation in less than 90 days prior to randomization
• Post cardiac valve replacement (either percutaneous or surgical)
• High cardiovascular risk:
• Patients with CCS class 4 angina
• Hospitalized with ACS within 1 month prior to randomization
• Patients undergoing PCI or CABG within the 3 months prior to randomization
• Patients on left ventricular assist device (LVAD) or post cardiac transplantation
• Patients with NYHA class 3 or 4 heart failure
• Any condition requiring treatment requires chronic use of an anticoagulant.
• Chronic kidney disease Stage 5 (with or without dialysis)
• Liver cirrhosis with platelet count \< 50,000/ mm3 and/or INR \>1.4
• Hematocrit \< 30% and hemoglobin \< 10 mg/dL

Sponsors & Collaborators

• Ochsner Health System: lead

Study Sites (1)

Ochsner Health

New Orleans, Louisiana, 70121, United States

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases

Interventions

Aspirin; Clopidogrel; Ticagrelor; Prasugrel Hydrochloride

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Adenosine; Purine Nucleosides; Purines; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Piperazines

Central Study Contacts

Mark B Effron, MD

CONTACT

(504) 842-2421; mark.effrob@ochsner.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 25, 2024
• Study Start: October 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 25, 2024

Record last verified: 2024-09

Locations

US (1)