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Antiplatelet
Antiplatelet Therapy for Vascular Disease (CAPTT Trial)
Phase 4
Waitlist Available
Research Sponsored by Ochsner Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 45 years
Scheduled for elective screening or surveillance outpatient colonoscopy
Must not have
Post cardiac valve replacement (either percutaneous or surgical)
Liver cirrhosis with platelet count < 50,000/ mm3 and/or INR >1.4
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group
Summary
This trial will investigate if patients on a blood-thinning medication (either aspirin or a P2Y12 inhibitor) are at higher risk of bleeding during a colonoscopy. Patients are often asked
Who is the study for?
This trial is for patients with vascular diseases who are on dual antiplatelet therapy (aspirin plus a P2Y12 inhibitor) and need a colonoscopy. They should be able to stop one of their medications before the procedure. Specific inclusion or exclusion criteria were not provided.
What is being tested?
The study tests whether stopping aspirin or a P2Y12 inhibitor (clopidogrel, prasugrel, ticagrelor) affects bleeding risk in patients undergoing colonoscopy. Participants will be randomly chosen to stop either medication one week prior to the procedure.
What are the potential side effects?
Potential side effects may include increased risk of bleeding during or after the colonoscopy for up to 30 days. The specific side effects of each drug aren't listed but can typically include bruising, nosebleeds, and prolonged bleeding from cuts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 45 years old or older.
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I am scheduled for a routine colonoscopy.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a heart valve replacement.
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I have liver cirrhosis with a low platelet count or high INR.
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I need an urgent or hospital-based colonoscopy.
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I have a heart assist device or have had a heart transplant.
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I have severe heart failure.
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I have a high risk of heart problems, including recent severe chest pain or heart surgery.
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I am on long-term blood thinners.
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I have advanced kidney disease and may or may not be on dialysis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Primary safety endpont
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: P2Y12 inhibitor onlyExperimental Treatment1 Intervention
Participants receiving a P2Y12 inhibitor only at time of the colonoscopy
Group II: Aspirin onlyActive Control1 Intervention
Participants receiving aspirin only at time of the colonoscopy
Find a Location
Who is running the clinical trial?
Ochsner Health SystemLead Sponsor
95 Previous Clinical Trials
89,800 Total Patients Enrolled
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