Coronary Arterial Disease (CAD)Phase 4CAPTTNCT06613191
Colonoscopy and Antiplatelet Therapy Trial
A Phase 4 study testing Aspirin and P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel) in people with Coronary Arterial Disease (CAD) and Peripheral Vascular Disease, run by Ochsner Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Coronary Arterial Disease (CAD), Peripheral Vascular Disease
- What is being tested?
- Aspirin and P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 30 Jun 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ochsner Health
New Orleans, Louisiana, 70121
Mark B Effron, MD, 504-842-2421, mark.effron@ochsner.org
Janak Shah, MD, 504-842-4015, janak.shah@ochsner.org
About this study
Official title: 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.
- Being tested
- Aspirin, P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)
- Keywords
- Colonoscopy, Antiplatelet therapy
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Aspirin only | Active comparator | Participants receiving aspirin only at time of the colonoscopy Receives: Drug: Aspirin |
| P2Y12 inhibitor only | Experimental | Participants receiving a P2Y12 inhibitor only at time of the colonoscopy Receives: Drug: P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Arterial Disease (CAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ochsner Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06613191
- Sponsor's protocol ID
- 2024.105
- Other IDs
- INVEST CVD
- Acronym
- CAPTT
- Status last verified
- Sep 2024
- First submitted
- 23 Sep 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- P2Y12 Inhibitor Versus Aspirin Monotherapy in Patients Undergoing Elective Screening and Surveillance Colonoscopy
- ClinicalTrials.gov ID
- NCT06613191
- Acronym / sponsor ID
- CAPTT / 2024.105
- Keywords
- Colonoscopy, Antiplatelet therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ochsner Health SystemUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin only | Active comparator | Drug: AspirinParticipants receiving aspirin only at time of the colonoscopy |
| P2Y12 inhibitor only | Experimental | Drug: P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)Participants receiving a P2Y12 inhibitor only at time of the colonoscopy |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AspirinParticipant will be on aspirin alone or P2Y12 inhibitor alone | Drug | Aspirin only |
| P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)Participant will be taking either P2Y12 inhibitor at time of colonoscopy | Drug | P2Y12 inhibitor only |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin and P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel) in people with Coronary Arterial Disease (CAD) and Peripheral Vascular Disease, run by Ochsner Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark B Effron, MD ((504) 842-2421, mark.effrob@ochsner.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary safety endpont (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024; AzTrials last refreshed its copy on 31 Oct 2026.