Prasugrel vs Ticagrelor for Coronary Artery Disease
(SWAP-7 Trial)
Recruiting in Palo Alto (17 mi)
Overseen byFrancesco Franchi, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: University of Florida
Must be taking: Aspirin, Prasugrel, Ticagrelor
Must not be taking: Oral anticoagulants, Heparin
Disqualifiers: Stroke, Coagulation disorders, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?Ticagrelor currently represents the most tested and commonly used P2Y12 inhibitor monotherapy following percutaneous coronary intervention. The purpose of this study is to conduct a head-to-head comparison on the pharmacodynamic efficacy of ticagrelor-based and prasugrel-based single antiplatelet therapy. To determine if the PD profiles of ticagrelor- and prasugrel-based SAPT are comparable, we aim to conduct a non-inferiority study between the two strategies.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does require participants to be on aspirin plus either prasugrel or ticagrelor for at least 90 days before joining. If you are on other medications, it's best to discuss with the trial team.
What data supports the effectiveness of the drugs Prasugrel and Ticagrelor for coronary artery disease?
Ticagrelor (Brilinta) was approved by the FDA based on the PLATO trial, which showed its effectiveness as an antiplatelet agent, meaning it helps prevent blood clots, in patients with coronary artery disease.
12345Is Ticagrelor safe for humans?
Ticagrelor, used for heart conditions, has a warning for bleeding risks and may cause slow heart rates or fainting in some people. It's important to use it with low-dose aspirin to avoid reducing its effectiveness.
678910How do prasugrel and ticagrelor differ from other drugs for coronary artery disease?
Prasugrel and ticagrelor are unique because they are newer antiplatelet drugs used with aspirin to prevent blood clots in patients with coronary artery disease undergoing procedures like stent placement. Ticagrelor acts faster and can be stopped more quickly than older drugs like clopidogrel, which may be beneficial in emergency situations.
1112131415Eligibility Criteria
This trial is for individuals with coronary artery disease who have undergone a procedure to open their heart's blood vessels. Participants should not be on dual antiplatelet therapy but instead need to switch to a single potent platelet blocker.Inclusion Criteria
Able to provide written informed consent
I am between 18 and 75 years old.
I've been on dual antiplatelet therapy with aspirin and either prasugrel or ticagrelor for over 90 days after my stent placement.
Exclusion Criteria
Prior history of stent thrombosis
I have severe liver problems.
I have had a stroke or a transient ischemic attack (TIA).
+8 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either ticagrelor or prasugrel monotherapy for 21±7 days
3-4 weeks
Regular monitoring visits
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study compares two single antiplatelet therapies: Prasugrel (10 mg) and Ticagrelor (90 mg), after heart vessel surgery, to see which one prevents blood clots better without causing too many bleeding problems.
2Treatment groups
Experimental Treatment
Active Control
Group I: Prasugrel monotherapyExperimental Treatment1 Intervention
Prasugrel 10 mg qd for 21±7 days
Group II: Ticagrelor monotherapyActive Control1 Intervention
Ticagrelor 90 mg bid monotherapy for 21±7 days
Prasugrel is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Effient for:
- Acute coronary syndrome
🇺🇸 Approved in United States as Effient for:
- Acute coronary syndrome
🇨🇦 Approved in Canada as Effient for:
- Acute coronary syndrome
🇯🇵 Approved in Japan as Effient for:
- Acute coronary syndrome
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Florida JacksonvilleJacksonville, FL
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Who Is Running the Clinical Trial?
University of FloridaLead Sponsor
References
Changes of ticagrelor formulary tiers in the USA: targeting private insurance providers away from government-funded plans. [2018]Ticagrelor (Brilinta®) is a new oral reversible antiplatelet agent approved by the FDA in July 2011 based on the results of the PLATO (Platelet Inhibition and Patient Outcomes) trial. However, despite very favorable and broad indications, the current clinical utilization of ticagrelor is woefully small.
Long-term safety and efficacy of sarilumab over 5 years in patients with rheumatoid arthritis refractory to TNF inhibitors. [2021]The objective of this study was to evaluate the long-term safety and efficacy of sarilumab over 5 years in patients with RA refractory to TNF inhibitors (TNFis).
Clinical Efficacy of Sarilumab Versus Upadacitinib Over 12 weeks: An Indirect Treatment Comparison. [2023]The efficacy of sarilumab and upadacitinib, in combination with disease-modifying antirheumatic drugs (DMARDs), was demonstrated in phase 3 clinical trials of patients with rheumatoid arthritis (RA) refractive to previous biologic DMARDs. In the absence of head-to-head clinical trials, the matching-adjusted indirect comparison (MAIC) and simulated treatment comparison (STC) estimate the relative efficacy of sarilumab and upadacitinib in patients with RA who had an inadequate response to previous biologic DMARDs.
Treatment Persistence and Clinical Outcomes of Tumor Necrosis Factor Inhibitor Cycling or Switching to a New Mechanism of Action Therapy: Real-world Observational Study of Rheumatoid Arthritis Patients in the United States with Prior Tumor Necrosis Factor Inhibitor Therapy. [2022]To examine treatment persistence and clinical outcomes associated with switching from a tumor necrosis factor inhibitor (TNFi) to a medication with a new mechanism of action (MOA) (abatacept, anakinra, rituximab, tocilizumab, or tofacitinib) versus cycling to another TNFi (adalimumab, certolizumab pegol, etanercept, golimumab, or infliximab) among patients with rheumatoid arthritis.
Tocilizumab for rheumatoid arthritis: a Cochrane systematic review. [2018]to compare the benefit and safety of tocilizumab to placebo in patients with rheumatoid arthritis (RA).
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.
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.
Ticagrelor-Induced Syncope/Bradyarrhythmia. [2021]Ticagrelor (BRILINTA®) is a very commonly used oral antiplatelet agent in acute coronary syndrome and after percutaneous coronary intervention (PCI). It is a reversible, direct inhibitor of the adenosine diphosphate (ADP) P2Y12 receptor. Most of the patients tolerate the drug well but it is known to cause brady arrhythmias and ventricular pauses, the exact mechanism of which is unclear. We present a case of acute coronary syndrome/unstable angina in a 58-year-old Caucasian gentleman requiring cardiac catheterization and PCI with drug eluting stent deployment and syncope following Ticagrelor loading from long ventricular pauses.
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 (brilinta), an antiplatelet drug for acute coronary syndrome. [2021]Ticagrelor (Brilinta) for acute coronary syndrome.
Ticagrelor or Prasugrel for Patients With Acute Coronary Syndrome Treated With Percutaneous Coronary Intervention: A Prespecified Subgroup Analysis of a Randomized Clinical Trial. [2022]It is unclear whether ticagrelor or prasugrel hydrochloride is superior for patients with acute coronary syndrome (ACS) treated with percutaneous coronary intervention (PCI).
Perioperative outcomes of cardiac surgery patients with ongoing ticagrelor therapy: boon and bane of a new drug. [2018]Ticagrelor (Brilique®) is a novel reversible platelet inhibitor at P2Y12 receptor used in patients with acute coronary syndrome and patients undergoing percutaneous coronary interventions. Unlike clopidogrel (Plavix®), ticagrelor has a quicker offset of action, and therefore, it seems that platelet function recovers faster on discontinuation of therapy. These drugs sometimes cannot be stopped before coronary artery bypass grafting due to the risk of stent thrombosis or in case of emergency operations. Therefore, we investigated whether the continued preoperative use of ticagrelor influences the perioperative course of cardiac surgical patients.
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.
Real-World Data of Prasugrel vs. Ticagrelor in Acute Myocardial Infarction: Results from the RENAMI Registry. [2019]Limited data are available concerning differences in clinical outcomes for real-life patients treated with ticagrelor versus prasugrel after percutaneous coronary intervention (PCI).
Head-to-head comparison of prasugrel versus ticagrelor in patients undergoing percutaneous coronary intervention: A meta-analysis of randomized controlled trials. [2018]We sought to compare the efficacy and safety of prasugrel and ticagrelor in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI).