Antiplatelet Therapy for Coronary Artery Disease

(TAILOR BLEED Trial)

Overseen By Andrea Burton, MPH, CCRP

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Florida

Must be taking: DAPT

Must not be taking: Oral anticoagulants

Disqualifiers: Stent thrombosis, Renal failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

90 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 3 4 5 6}

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. ^{1 2 7 8 9}

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

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.

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

Group I: Potent P2Y12 monotherapy Experimental Treatment 1 Intervention

Potent P2Y12 inhibitor with prasugrel 10 mg od or ticagrelor 90 mg BID.

Group II: DAPT de-escalation Active Control 1 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:

Approved in European Union as Aspirin for:

• Pain relief
• Fever reduction
• Inflammation
• Cardiovascular disease prevention
• Preeclampsia prevention

Approved in United States as Aspirin for:

• Pain relief
• Fever reduction
• Inflammation
• Cardiovascular disease prevention
• Preeclampsia prevention

Approved in Canada as Aspirin for:

• Pain relief
• Fever reduction
• Inflammation
• Cardiovascular disease prevention
• Preeclampsia prevention

Approved in China as Aspirin for:

• Pain relief
• Fever reduction
• Inflammation
• Cardiovascular disease prevention

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ticagrelor (brilinta), an antiplatelet drug for acute coronary syndrome. Fuller, R., Chavez, B.[2021]

Ticagrelor is a new type of P2Y(12) antagonist that works differently from traditional antiplatelet medications like clopidogrel and prasugrel, providing a potentially more effective option for treating acute coronary syndromes.

Clinical trials have shown that ticagrelor, when used with aspirin, has a favorable safety profile and can overcome some limitations associated with clopidogrel, making it a valuable addition to antiplatelet therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ticagrelor: a P2Y12 antagonist for use in acute coronary syndromes. Wijeyeratne, YD., Joshi, R., Heptinstall, S.[2022]

Prasugrel (Effient) has been approved by the FDA as an oral antiplatelet medication to be used alongside aspirin for reducing thrombotic cardiovascular events in patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI).

This new treatment option will compete with the existing antiplatelet drug clopidogrel (Plavix), potentially offering patients and healthcare providers more choices in managing cardiovascular risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prasugrel (Effient) vs. clopidogrel (Plavix). [2018]

Ticagrelor (Brilinta™) was approved by the FDA for treating acute coronary syndromes based on the PLATO trial, which involved 18,624 patients and compared its efficacy to clopidogrel over 6-12 months.

Despite its approval, there were significant concerns from FDA reviewers regarding its efficacy and safety, particularly related to bleeding risks and the potential reduction in effectiveness when used with high doses of aspirin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ticagrelor FDA approval issues revisited. Serebruany, VL.[2018]

Aspirin is the primary antiplatelet therapy for secondary prevention of coronary artery disease (CAD), often used in combination with clopidogrel for patients undergoing procedures like percutaneous coronary intervention.

In patients with acute coronary syndrome, newer agents like prasugrel and ticagrelor provide better outcomes by reducing ischemic events, but they also carry a higher risk of bleeding compared to clopidogrel, with prasugrel being particularly effective for those with ST elevation myocardial infarction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antiplatelet therapy for secondary prevention of coronary artery disease. Pilgrim, T., Windecker, S.[2022]

Dual antiplatelet therapy, which includes aspirin and an additional antiplatelet agent, significantly reduces the risk of stent thrombosis and cardiovascular events in patients with acute coronary syndromes (ACS).

This review compares the effectiveness of three antiplatelet agents—clopidogrel, prasugrel, and ticagrelor—providing clinicians with guidance on selecting the most appropriate option for ACS treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clopidogrel, prasugrel, or ticagrelor? a practical guide to use of antiplatelet agents in patients with acute coronary syndromes. Norgard, NB., Dinicolantonio, JJ.[2018]

In a meta-analysis of 9 randomized controlled trials involving 6990 patients, ticagrelor and prasugrel showed no significant differences in major cardiovascular outcomes such as mortality and major adverse cardiovascular events (MACEs).

Both medications were also associated with similar rates of bleeding events, indicating that either drug can be safely used in patients with acute coronary syndrome undergoing percutaneous coronary intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prasugrel Versus Ticagrelor in Patients with Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: a Systematic Review and Meta-analysis of Randomized Trials. Ray, A., Najmi, A., Khandelwal, G., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Ticagrelor (Brilinta)--better than clopidogrel (Plavix)? [2018]

2. England pubmed.ncbi.nlm.nih.gov

Ticagrelor for acute coronary syndrome? [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Ticagrelor (brilinta), an antiplatelet drug for acute coronary syndrome. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Ticagrelor: a P2Y12 antagonist for use in acute coronary syndromes. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Prasugrel (Effient) vs. clopidogrel (Plavix). [2018]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Ticagrelor FDA approval issues revisited. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Antiplatelet therapy for secondary prevention of coronary artery disease. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Clopidogrel, prasugrel, or ticagrelor? a practical guide to use of antiplatelet agents in patients with acute coronary syndromes. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Prasugrel Versus Ticagrelor in Patients with Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: a Systematic Review and Meta-analysis of Randomized Trials. [2021]