Antiplatelet Therapy for Coronary Artery Disease
(TAILOR BLEED Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial involves changing your current medication strategy. If you're on dual antiplatelet therapy (DAPT) with aspirin and either prasugrel or ticagrelor, you may need to switch to a different combination or monotherapy as part of the study.
What data supports the effectiveness of the drug Ticagrelor (Brilinta) for coronary artery disease?
Research shows that Ticagrelor, when used with low-dose aspirin, is effective in reducing the rate of heart-related events in patients with acute coronary syndrome, a condition related to coronary artery disease. It is considered to have advantages over other similar drugs like clopidogrel and prasugrel in terms of efficacy and safety.12345
Is antiplatelet therapy safe for humans?
Antiplatelet drugs like ticagrelor (Brilinta), clopidogrel (Plavix), and prasugrel (Effient) are generally safe for humans, but they come with a risk of bleeding, which is a common warning for these types of medications. Ticagrelor has a specific warning that taking more than 100 mg of aspirin daily may reduce its effectiveness.13456
How is antiplatelet drug therapy for coronary artery disease unique?
Antiplatelet therapy for coronary artery disease often involves a combination of aspirin with drugs like clopidogrel, prasugrel, or ticagrelor. Ticagrelor is unique because it can reduce mortality without increasing bleeding risk during coronary artery bypass surgery, unlike clopidogrel, and it offers a greater net clinical benefit in reducing ischemic events compared to clopidogrel.12789
What is the purpose of this trial?
Two strategies have both proven to be effective in reducing bleeding complications while preserving efficacy compared with maintaining long-term DAPT with aspirin and a potent P2Y12 inhibitor: a) DAPT de-escalation (i.e., switching from prasugrel or ticagrelor to clopidogrel while maintaining aspirin) and b) potent P2Y12 inhibitor monotherapy (i.e., maintaining prasugrel or ticagrelor and dropping aspirin). These strategies have been tested in a number of trials and have led to changes in practice guidelines to consider either one of these strategies as bleeding reduction approaches among ACS patients undergoing PCI. However, comparative assessments between DAPT de-escalation and potent P2Y12 inhibitor monotherapy are lacking.
Research Team
Dominick J Angiolillo, MD,PhD
Principal Investigator
University of Florida College of Medicine Jacksonville
Eligibility Criteria
This trial is for adults over 18 who have had a coronary procedure (PCI) and been on dual antiplatelet therapy with aspirin and either prasugrel or ticagrelor for at least 30 days to over 3 months. It's not for those with past stent thrombosis, on oral anticoagulants, dialysis patients, liver issues, bleeding disorders, unstable health conditions, allergy to clopidogrel or women who are pregnant/breastfeeding unless using birth control.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either potent P2Y12 inhibitor monotherapy or DAPT de-escalation for bleeding reduction
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Aspirin
- Clopidogrel
- Prasugrel or Ticagrelor
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?
University of Florida
Lead Sponsor