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NCT Number: NCT06613191

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, 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.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Emergent or inpatient Colonoscopy

Treatment and study plan

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

Primary outcomes

  1. Primary safety endpont

    Time frame: 7 days

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mark B Effron, MD

CONTACT

[email protected]

(504) 842-2421

Sponsors and collaborators

Lead sponsor

Ochsner Health System

Other

Registry information

Official study title

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

Acronym: CAPTT

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 25, 2024
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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