90 Participants Needed

Antiplatelet Therapy for Coronary Artery Disease

(TAILOR BLEED Trial)

DJ
AB
Overseen ByAndrea Burton, MPH, CCRP
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of Florida
Must be taking: DAPT
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human 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

DJ

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

I've been on aspirin and either prasugrel or ticagrelor after a heart procedure for over 30 days.
I had a heart issue, got a stent, and have been on aspirin and another heart medicine for over 3 months.
Provide written informed consent

Exclusion Criteria

You are allergic to clopidogrel.
I am on dialysis for kidney failure.
I am not pregnant or breastfeeding and use birth control.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either potent P2Y12 inhibitor monotherapy or DAPT de-escalation for bleeding reduction

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Aspirin
  • Clopidogrel
  • Prasugrel or Ticagrelor
Trial Overview The study tests two strategies in patients after PCI: switching from stronger blood thinners (prasugrel/ticagrelor) to a milder one (clopidogrel) while keeping aspirin; versus continuing the strong blood thinner alone without aspirin. The goal is to see which method better reduces bleeding without losing effectiveness.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Potent P2Y12 monotherapyExperimental Treatment1 Intervention
Potent P2Y12 inhibitor with prasugrel 10 mg od or ticagrelor 90 mg BID.
Group II: DAPT de-escalationActive Control1 Intervention
Aspirin 81-mg od and clopidogrel 75-mg qd.

Aspirin is already approved in European Union, United States, Canada, China for the following indications:

๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Aspirin for:
  • Pain relief
  • Fever reduction
  • Inflammation
  • Cardiovascular disease prevention
  • Preeclampsia prevention
๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Aspirin for:
  • Pain relief
  • Fever reduction
  • Inflammation
  • Cardiovascular disease prevention
  • Preeclampsia prevention
๐Ÿ‡จ๐Ÿ‡ฆ
Approved in Canada as Aspirin for:
  • Pain relief
  • Fever reduction
  • Inflammation
  • Cardiovascular disease prevention
  • Preeclampsia prevention
๐Ÿ‡จ๐Ÿ‡ณ
Approved in China as Aspirin for:
  • Pain relief
  • Fever reduction
  • Inflammation
  • Cardiovascular disease prevention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials
1,428
Recruited
987,000+

Findings from Research

Ticagrelor (Brilinta) has been approved by the FDA as an oral antiplatelet medication to be used with low-dose aspirin for reducing thrombotic cardiovascular events in patients with acute coronary syndrome (ACS).
Ticagrelor will compete with existing medications like clopidogrel (Plavix) and prasugrel (Effient), especially as clopidogrel is expected to become available as a generic option soon.
Ticagrelor (Brilinta)--better than clopidogrel (Plavix)?[2018]
Ticagrelor is a newly licensed oral antiplatelet medication in the UK that can be used with aspirin for patients with acute coronary syndrome (ACS), potentially offering a safer alternative to traditional dual therapy with clopidogrel or prasugrel, which increases bleeding risk.
This review evaluates whether ticagrelor provides greater efficacy or a lower risk of bleeding complications compared to standard antiplatelet therapies, highlighting its potential benefits in managing ACS.
Ticagrelor for acute coronary syndrome?[2018]
Ticagrelor is an effective antiplatelet medication used in patients with acute coronary syndrome, helping to reduce the risk of heart attacks and other cardiovascular events.
Clinical studies have shown that ticagrelor provides a greater reduction in major adverse cardiovascular events compared to traditional treatments like clopidogrel, making it a preferred choice in acute settings.
Ticagrelor (brilinta), an antiplatelet drug for acute coronary syndrome.Fuller, R., Chavez, B.[2021]

References

Ticagrelor (Brilinta)--better than clopidogrel (Plavix)? [2018]
Ticagrelor for acute coronary syndrome? [2018]
Ticagrelor (brilinta), an antiplatelet drug for acute coronary syndrome. [2021]
Ticagrelor: a P2Y12 antagonist for use in acute coronary syndromes. [2022]
Prasugrel (Effient) vs. clopidogrel (Plavix). [2018]
Ticagrelor FDA approval issues revisited. [2018]
Antiplatelet therapy for secondary prevention of coronary artery disease. [2022]
Clopidogrel, prasugrel, or ticagrelor? a practical guide to use of antiplatelet agents in patients with acute coronary syndromes. [2018]
Prasugrel Versus Ticagrelor in Patients with Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: a Systematic Review and Meta-analysis of Randomized Trials. [2021]
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