Antiplatelet Therapy for Coronary Artery Disease
(TAILOR BLEED Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores two treatment approaches for individuals with coronary artery disease who have undergone a stent procedure. The goal is to determine which method better reduces bleeding while maintaining effectiveness. One approach involves switching from stronger medications like prasugrel or ticagrelor to clopidogrel while continuing aspirin (an antiplatelet drug). The other approach involves stopping aspirin and continuing with prasugrel or ticagrelor alone. The trial seeks participants who have been taking these medications for at least a month after a stent procedure. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, and research aims to understand how it benefits more patients.
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 is the safety track record for these treatments?
Research has shown that both prasugrel and ticagrelor are generally safe and effective for treating coronary artery disease. One study comparing these two found that prasugrel significantly reduced the risk of major heart problems, such as heart attacks, but it might increase the chance of bleeding. Ticagrelor is often preferred due to its usually lower risk of causing bleeding.
In the DAPT de-escalation approach, which involves switching to clopidogrel while continuing aspirin, these medications are also generally safe. Clopidogrel is widely used and known to be safe when taken with aspirin.
Overall, these treatments have been tested in many studies and are part of established medical guidelines, indicating they are safe for most patients. However, individual experiences can vary, so discussing with healthcare providers is important to determine if joining a trial is the right choice.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these treatments for coronary artery disease because they offer potentially more effective and safer alternatives to the standard dual antiplatelet therapy (DAPT). The potent P2Y12 monotherapy with prasugrel or ticagrelor could simplify the treatment regimen by reducing the need for aspirin, which may lower the risk of bleeding complications. Meanwhile, the DAPT de-escalation strategy with aspirin and clopidogrel aims to balance efficacy and safety by minimizing the intensity of platelet inhibition over time. These approaches could lead to better patient outcomes with fewer side effects, making them promising avenues in coronary artery disease management.
What evidence suggests that this trial's treatments could be effective for coronary artery disease?
This trial compares two approaches for treating coronary artery disease. One arm involves potent P2Y12 monotherapy with prasugrel or ticagrelor. Research shows these drugs can lower the risk of major heart problems, such as heart attacks, more effectively than clopidogrel, though they might increase bleeding risk. For instance, prasugrel effectively reduces serious heart issues but carries a higher bleeding risk compared to ticagrelor. The other arm involves DAPT de-escalation with aspirin and clopidogrel, which can also reduce bleeding risks while effectively managing the condition. Current guidelines support both approaches as viable options for reducing bleeding in patients who have undergone procedures to open blocked arteries.12346
Who Is on the Research Team?
Dominick J Angiolillo, MD,PhD
Principal Investigator
University of Florida College of Medicine Jacksonville
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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