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| ID | Type | Description | Link |
|---|---|---|---|
| INVEST CVD | Other Identifier | Ochsner Clinic Foundation |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspirin only | Active Comparator | Participants receiving aspirin only at time of the colonoscopy |
|
| P2Y12 inhibitor only | Experimental | Participants receiving a P2Y12 inhibitor only at time of the colonoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin | Drug | Participant will be on aspirin alone or P2Y12 inhibitor alone |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Primary safety endpont | Composite of:
| 7 days |
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Inclusion Criteria:
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 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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark B Effron, MD | Contact | (504) 842-2421 | mark.effrob@ochsner.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ochsner Health | New Orleans | Louisiana | 70121 | United States |
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| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| D000077144 | Clopidogrel |
| D000077486 | Ticagrelor |
| D000068799 | Prasugrel Hydrochloride |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel) |
| Drug |
Participant will be taking either P2Y12 inhibitor at time of colonoscopy |
|
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D010879 | Piperazines |