A Phase 4 interventional study of Aspirin and P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel) in Coronary Arterial Disease (CAD) and Peripheral Vascular Disease, sponsored by Ochsner Health System. Not yet recruiting at 1 site in United States. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2024-09-25.
Sponsored by Ochsner Health System · Phase 4, Interventional, and Supportive care
Among 187 studies in Peripheral Vascular Diseases with a site in United States — 18 open to participants now, 23 under way, 2 of them phase 3. Peripheral Vascular Diseases · United States.
Among the 187 studies in Peripheral Vascular Diseases with a site in United States, this one is the 71st largest by planned enrollment of the 158 interventional ones that give a count, is one of 11 that started in 2024, is one of 11 in phase 4, reaches primary completion later than 3 of the 22 other live ones, and was the 180th registered.
443 studies on the registry are indexed under Peripheral Vascular Diseases; 44 are open to participants now.
This study's planned enrollment of 100 is above the median of 80 across 327 interventional studies indexed under Peripheral Vascular Diseases.
Browse Peripheral Vascular Diseases studies →18 of the 187 studies in Peripheral Vascular Diseases with a site in United States are open now.
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 32 Peripheral Vascular Diseases studies recruiting now, 19 (59%) set no upper age limit and 4 (13%) stop at 75 or younger; 2 take children under 18; 4 take healthy volunteers.
This study: 45 Years and older · all sexes · no healthy volunteers.
The full table on the hub →187 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 26 · Phase 2 36 · Phase 3 25 · Phase 4 11
First in 1994; this study’s year is marked. 11 started in 2024.
Median enrollment 82 across the 158 interventional studies, 200 across the 26 observational. Of the 147 that completed or were terminated, 57 (39%) have results posted.
92 of 187 have an industry lead sponsor. The 10 most frequent:
Ochsner Health System is the lead sponsor of 57 studies on the registry; 7 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Ochsner Health System has 2 studies filed under Peripheral Vascular Diseases — fewer than ten, so there is no comparison to draw.
10 of the studies in Peripheral Vascular Diseases with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07639853Medtronic EndovascularCase-Specific Health Care Professional Clinical Survey for Concerto Versa™ Detachable Coils | 2026-11 |
| NCT06492733Versono Medical LtdFastWire REvascularisation of Extremities, (For LOWer Limbs) - FREEFLOW | 2026-11 |
| NCT06399809Northwestern UniversityFisetin to Reduce Senescence and Mobility Impairment in PAD | 2026-11 |
| NCT06319339University of NebraskaImpact of Nrf2 Activation on Macrovascular, Microvascular & Leg Function & Walking Capacity in Peripheral Artery Disease | 2026-12 |
| NCT04922762Virginia Commonwealth UniversityExamining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 2 | 2026-12 |
Among the 187 studies in Peripheral Vascular Diseases with a site in United States, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
High cardiovascular risk:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receiving aspirin only at time of the colonoscopy
Drug: Aspirin
Participants receiving a P2Y12 inhibitor only at time of the colonoscopy
Drug: P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)
Participant will be on aspirin alone or P2Y12 inhibitor alone
Participant will be taking either P2Y12 inhibitor at time of colonoscopy
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.
Time frame: 7 days
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Oct 2024; primary completion for Dec 2025, 14 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: P2Y12 Inhibitor
Peripheral Vascular Diseases →
Ochsner Health System