Antiplatelet Therapy for Coronary Artery Disease
(TAILOR BLEED Trial)
Recruiting in Palo Alto (17 mi)
Overseen byDominick J Angiolillo, MD,PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: University of Florida
Must be taking: DAPT
Must not be taking: Oral anticoagulants
Disqualifiers: Stent thrombosis, Renal failure, others
No Placebo Group
Prior Safety Data
Trial Summary
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.
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.
12345Is 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.
13456How 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.
12789Eligibility 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 am 18 years old or older.
I had a heart issue, got a stent, and have been on aspirin and another heart medicine for over 3 months.
+1 more
Exclusion Criteria
You are allergic to clopidogrel.
I am on dialysis for kidney failure.
I am not pregnant or breastfeeding and use birth control.
+5 more
Trial 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
Participant Groups
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.
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:
🇪🇺 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of FloridaJacksonville, FL
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Who Is Running the Clinical Trial?
University of FloridaLead Sponsor
References
Ticagrelor (Brilinta)--better than clopidogrel (Plavix)? [2018]The FDA has approved ticagrelor (Brilinta-AstraZeneca), an oral antiplatelet drug, for use with low-dose aspirin to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS). It will compete with clopidogrel (Plavix) and prasugrel (Effient) for such use. Clopidogrel is expected to become available generically in the US within the next few months.
Ticagrelor for acute coronary syndrome? [2018]Current guidelines from the National Institute for Clinical Excellence (NICE) recommend antiplatelet therapy comprising aspirin plus either clopidogrel or prasugrel for patients with acute coronary syndrome (ACS). However, such dual therapy increases the likelihood of bleeding compared to that with aspirin alone. Ticagrelor (Brilique - Astra-Zeneca) is a new oral antiplatelet drug recently licensed in the UK (since publication of the NICE guidelines) for use with aspirin in patients with ACS, including those managed medically or undergoing percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). Here we review the place of ticagrelor in the management of people with ACS, and whether it offers advantages over standard therapy in terms of greater efficacy or lower likelihood of bleeding complications.
Ticagrelor (brilinta), an antiplatelet drug for acute coronary syndrome. [2021]Ticagrelor (Brilinta) for acute coronary syndrome.
Ticagrelor: a P2Y12 antagonist for use in acute coronary syndromes. [2022]Agents that inhibit platelet function are used routinely in the treatment and prevention of acute coronary syndromes. The main antiplatelet treatments used combine aspirin with one of the thienopyridine P2Y(12) antagonists, either clopidogrel or prasugrel. By blocking the synthesis of thromboxane A(2) in platelets and by blocking the effects of ADP, respectively, these agents reduce platelet activity, platelet aggregation and thrombus formation. Ticagrelor (marketed by AstraZeneca as Brilinta™ in the USA, and as Brilique(®) or Possia(®) in Europe) is a cyclopentyl-triazolo-pyrimidine, a new chemical class of P2Y(12) antagonist that is now approved for use in the wide spectrum of acute coronary syndromes. In this article we provide an overview of ticagrelor. We discuss the differences in mode of action compared with other P2Y(12) antagonists, examine its pharmacodynamic, pharmacokinetic and safety profile, and summarize the various clinical trials that have provided information on its efficacy in combination with aspirin. Ticagrelor appears to overcome some of the difficulties that have been encountered with other antiplatelet treatments, clopidogrel in particular.
Prasugrel (Effient) vs. clopidogrel (Plavix). [2018]The FDA has approved prasugrel (Effient--Lilly/Daiichi Sankyo), an oral antiplatelet drug, for use with aspirin to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndromes (ACS) being managed with percutaneous coronary intervention (PCI).1 It will compete with clopidogrel (Plavix) for such use.
Ticagrelor FDA approval issues revisited. [2018]On July 20, 2011, the Food and Drug Administration (FDA) approved ticagrelor (Brilinta™) for use during acute coronary syndromes. The drug labeling includes a 'black box' warning for bleeding risks, conventional for antithrombotics, and a unique warning that higher than 100 mg/daily maintenance treatment with aspirin may reduce ticagrelor effectiveness. The approval was granted following ticagrelor secondary reviews, and review of complete response by FDA officials.
Antiplatelet therapy for secondary prevention of coronary artery disease. [2022]The choice and duration of antiplatelet therapy for secondary prevention of coronary artery disease (CAD) is determined by the clinical context and treatment strategy. Oral antiplatelet agents for secondary prevention include the cyclo-oxygenase-1 inhibitor aspirin, and the ADP dependent P2Y12 inhibitors clopidogrel, prasugrel and ticagrelor. Aspirin constitutes the cornerstone in secondary prevention of CAD and is complemented by clopidogrel in patients with stable CAD undergoing percutaneous coronary intervention. Among patients with acute coronary syndrome, prasugrel and ticagrelor improve net clinical outcome by reducing ischaemic adverse events at the expense of an increased risk of bleeding as compared with clopidogrel. Prasugrel appears particularly effective among patients with ST elevation myocardial infarction to reduce the risk of stent thrombosis compared with clopidogrel, and offered a greater net clinical benefit among patients with diabetes compared with patients without diabetes. Ticagrelor is associated with reduced mortality without increasing the rate of coronary artery bypass graft (CABG)-related bleeding as compared with clopidogrel. Dual antiplatelet therapy should be continued for a minimum of 1 year among patients with acute coronary syndrome irrespective of stent type; among patients with stable CAD treated with new generation drug-eluting stents, available data suggest no benefit to prolong antiplatelet treatment beyond 6 months.
Clopidogrel, prasugrel, or ticagrelor? a practical guide to use of antiplatelet agents in patients with acute coronary syndromes. [2018]Aspirin is a cornerstone of therapy in the treatment of patients with acute coronary syndromes (ACS). However, dual antiplatelet therapy reduces the risk of stent thrombosis and cardiovascular events compared with aspirin alone in the treatment of patients with ACS. Recently, there has been debate as to which antiplatelet agent should be added to aspirin in the ACS treatment regimen. This review summarizes the pharmacologic and clinical data comparing clopidogrel, prasugrel, and ticagrelor, and provides a practical guide to clinicians for determining which antiplatelet to use for patients with ACS.
Prasugrel Versus Ticagrelor in Patients with Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: a Systematic Review and Meta-analysis of Randomized Trials. [2021]Dual antiplatelet therapy (DAPT) with aspirin and ticagrelor or prasugrel is the mainstay of treatment for patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI). We aimed to systematically perform a head-to-head comparison of ticagrelor vs prasugrel in terms of efficacy and safety.