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Not yet recruiting NCT06613191

Colonoscopy and Antiplatelet Therapy Trial

Phase IV Interventional Coronary Arterial Disease (CAD) Peripheral Vascular Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aspirin, P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel).
Who it may be relevant to
Registry conditions: Coronary Arterial Disease (CAD), Peripheral Vascular Disease. Basic parameters: from 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Aspirin
    Participant will be on aspirin alone or P2Y12 inhibitor alone
  • Drug P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)
    Participant will be taking either P2Y12 inhibitor at time of colonoscopy

Primary outcome measures

  • Primary safety endpont [Time frame: 7 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Ochsner Health — New Orleans

Identifiers

NCT: NCT06613191 · 2024.105 · INVEST CVD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗