Antiplatelet Therapy for Vascular Disease
(CAPTT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the best way to minimize bleeding risks for individuals with vascular disease taking dual antiplatelet therapy (a combination of aspirin and another drug to prevent blood clots) who need a colonoscopy. It compares the effects of stopping either aspirin or the other antiplatelet drug a week before the procedure. Participants will be randomly assigned to temporarily stop one of these medications. This trial suits individuals 45 years or older with stable heart-related conditions who currently take both aspirin and another antiplatelet drug and are planning an elective colonoscopy. As a Phase 4 trial, this research focuses on understanding how an already FDA-approved and effective treatment can benefit more patients.
Will I have to stop taking my current medications?
Yes, if you are taking both aspirin and a P2Y12 inhibitor, you will be asked to stop either aspirin or the P2Y12 inhibitor one week before the procedure.
What is the safety track record for aspirin and P2Y12 inhibitors?
Research shows that medications like clopidogrel, prasugrel, or ticagrelor can slightly increase the risk of bleeding. Studies have found a 0.5-1% increase in bleeding events for people taking these drugs. This is important to consider, especially before procedures like a colonoscopy.
However, these medications also reduce the risk of heart attacks and strokes, which is why doctors often prescribe them for people with heart conditions. Aspirin is another option that is generally well-tolerated and is often used alone or with other medications to help prevent heart problems.
In summary, while medications like clopidogrel, prasugrel, or ticagrelor can slightly raise the risk of bleeding, they effectively prevent serious heart issues. Aspirin is a well-known medication with a good safety record. Both options have their own risks and benefits, so careful consideration is important when thinking about joining a trial.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these treatments for vascular disease because they offer two distinct approaches to managing platelet activity. Aspirin, a well-known antiplatelet drug, works by inhibiting cyclooxygenase enzymes, which reduces thromboxane production and prevents blood clot formation. On the other hand, P2Y12 inhibitors like clopidogrel, ticagrelor, and prasugrel target the P2Y12 receptor on platelets, offering a different mechanism to inhibit platelet aggregation. By exploring these varied mechanisms, the trial hopes to clarify which approach is more effective or safer for patients undergoing procedures like colonoscopies.
What evidence suggests that this trial's treatments could be effective for reducing bleeding risk during colonoscopy?
Research has shown that medications called P2Y12 inhibitors, such as clopidogrel, ticagrelor, and prasugrel, lower the risk of heart attacks and strokes. Specifically, ticagrelor significantly reduces deaths from heart-related causes, heart attacks, and strokes. Studies suggest that newer P2Y12 inhibitors outperform clopidogrel in preventing these events. Meanwhile, aspirin is widely recognized for preventing blood clots, which also helps stop heart attacks and strokes. Both treatments aim to prevent clots but do so in slightly different ways. In this trial, participants will receive either aspirin only or a P2Y12 inhibitor only to study how these treatments might affect bleeding risk during colonoscopy procedures.13678
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomly assigned to stop either aspirin or the P2Y12 inhibitor 1 week before the colonoscopy procedure
Follow-up
Participants are monitored for periprocedural bleeding and bleeding after the procedure
What Are the Treatments Tested in This Trial?
Interventions
- Aspirin
- P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)
Trial Overview
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants receiving a P2Y12 inhibitor only at time of the colonoscopy
Participants receiving aspirin only at time of the colonoscopy
Aspirin is already approved in European Union, United States, Canada, China for the following indications:
- Pain relief
- Fever reduction
- Inflammation
- Cardiovascular disease prevention
- Preeclampsia prevention
- Pain relief
- Fever reduction
- Inflammation
- Cardiovascular disease prevention
- Preeclampsia prevention
- Pain relief
- Fever reduction
- Inflammation
- Cardiovascular disease prevention
- Preeclampsia prevention
- Pain relief
- Fever reduction
- Inflammation
- Cardiovascular disease prevention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ochsner Health System
Lead Sponsor
Citations
Comparative Effectiveness of Ticagrelor, Prasugrel, and ...
The primary outcome was hospitalization due to a composite cardiovascular outcome at days 30, 90, and 180 after the start of the index P2Y12 ...
Comparative Efficacy and Safety of Oral P2Y12 Inhibitors in ...
Ticagrelor significantly reduced the composite rate of death from vascular causes, MI, or stroke and overall mortality with an increase in ...
3.
newsroom.heart.org
newsroom.heart.org/news/effectiveness-of-anti-clotting-meds-after-stent-placement-varied-in-people-with-diabetesEffectiveness of anti-clotting meds after stent placement ...
The primary composite outcome of heart attack, stroke, bleeding complications or death occurred at a rate of 16.57% in the ticagrelor group and ...
Comprehensive comparative efficacy and safety of potent ...
This meta-analysis merges RCTs and RWE studies and comprehensively evidences newer potent P2Y 12 inhibitors are significantly more effective than clopidogrel.
5.
nyulangone.org
nyulangone.org/news/effectiveness-anticlotting-medications-after-stent-placement-varied-people-diabetesEffectiveness of Anticlotting Medications After Stent ...
The primary combined outcome of heart attack, stroke, bleeding complications, and death occurred at a 16.57 percent rate in patients taking ...
P2Y12 Inhibitors in Acute Coronary Syndromes: A Real- ...
Randomized trial data have demonstrated an approximately 2% reduction in ischemic events and a 0.5โ1% increase in bleeding events with ...
Efficacy and safety of newer P2Y12 inhibitors for acute ...
Myocardial infarction (0.75, 0.63โ0.89) and major adverse cardiovascular events (0.80, 0.69โ0.94) were reduced by prasugrel. Stent thrombosis ...
Assessment of Pretreatment With Oral P2Y12 Inhibitors ...
This systematic review and meta-analysis assesses the association between oral P2Y12 inhibitor pretreatment and cardiovascular and bleeding ...
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