This section provides a highlevel overview of the rct that the described realworld evidence study is trying to replicate as closely as possible given the remaining limitations inherent in the healthcare databases. The increase in holterdetected ventricular pauses with ticagrelor was higher in patients with chronic heart failure chf than in the overall study population during the acute phase of acs, but not at one month with ticagrelor or compared to clopidogrel. Ticagrelor versus clopidogrel in patients with acute coronary syndrome. Plato was a randomized, doubleblind, controlled comparative study in international acs patients hospitalized with or without stsegment elevation, with an onset of symptoms within 24 hours n18,624 1,2 brilinta and clopidogrel were studied with aspirin and other therapies 1. P2y12 inhibition with ticagrelor was better than that with. In the platelet inhibition and patient outcomes plato study, 9 treatment with ticagrelor compared with clopidogrel significantly reduced the rate of death from vascular causes, mi, or stroke. Brilique ticagrelor clinical studies pegasustimi 54 study. Prehospital ticagrelor in stsegment elevation myocardial.
Hat ticagrelor vorteile vor clopidogrel beim akuten koronaren syndrom. Association of ticagrelor vs clopidogrel with major. Stevens, lars wallentin, for the plato study group, ticagrelor vs. Comparison ticagrelor clopidogrel patients a planned invasive. Fda approval was based on results of the plato study which showed that ticagrelor was superior to clopidogrel in reducing the risk of vascular death, mi, or stroke with similar to higher rates of bleeding. Brilinta ticagrelor tablets for health care professionals. Evidenzreport ticagrelor beim akuten koronaren syndrom degam. Stent thrombosis with ticagrelor versus clopidogrel in. Furthermore, reductions in total mortality, cv death and noncv death for the ticagrelor group were significantly greater than in the original trial. Ticagrelor is an oral, reversible, directacting inhibitor of the adenosine diphosphate receptor p2y12. I would say it is the largest single genetic study.
Replication of ticagrelor versus clopidogrel in patients with. Aug 19, 2014 similar questions have been responded to by the independent plato executive committee which led the clinical trial. In the platelet inhibition and patient outcomes plato study, 9 treatment with ticagrelor compared with clopidogrel significantly reduced the rate of death from vascular causes, mi, or stroke without an increase in the rate of overall major bleeding. By 12 months, cabg patients receiving ticagrelor saw a relative reduction in the primary endpoint cv death, mi, or stroke that was consistent with the original plato trial. Ticagrelor versus clopidogrel in patients with acute. Unless the regulatory authorities discover serious.
Comparison of ticagrelor with clopidogrel in patients with a planned. In this multicenter, doubleblind, randomized trial, we compared ticagrelor 180mg loading. Originally published in 2009 in nejm, this study was a multicenter trial, which randomized patients to treatment with clopidogrel or ticagrelor in addition to aspirin after acs. Ticagrelor trade name brilinta, brilique, and formerly possia is a platelet aggregation inhibitor produced by astrazeneca. Pdf the plato trial revealed a remarkable advantage of ticagrelor over clopidogrel in acs patients. Plato shows that treatment with ticagrelor as compared with clopidogrel in patients with acute coronary syndromes significantly reduced the rate of death from vascular causes, myocardial. The plato study compared brilique ticagrelor 180mg loading dose, 90mg twice daily thereafter and clopidogrel 300mg to 600mg loading dose, 75 mg daily thereafter for the prevention of thrombotic cv events cv death, mi, or stroke in 18,624 patients admitted to hospital with an acs with or without stsegment elevation.
Ticagrelor is an antagonist of the p2y 12 receptor. Association of ticagrelor vs clopidogrel with major adverse. Jun 17, 2011 conclusions in patients with acute coronary syndrome initially intended for noninvasive management, the benefits of ticagrelor over clopidogrel were consistent with those from the overall plato results, indicating the broad benefits of p2y12 inhibition with ticagrelor regardless of intended management strategy. Ticagrelor for the treatment of acute coronary syndromes. In patients with acs excluding stemi treated with fibrinolysis, or lowrisk unstable angina, ticagrelor. This study compared administration of the antiplatelet agent ticagrelor in the ambulance with administration in the cath lab in patients with stsegment elevation mi. In plato, for brilinta vs clopidogrel, noncabg plato defined major bleeding 3. Cornel, david erlinge, steen husted, frederic kontny, juan maya, jose c. Patienten wesentliche eingeschlossene studie plato 3 fand eine signifikante senkung. The results of the primary outcome of isarreact 5 expressed as prasugrel vs ticagrelor are 6. Each study enrolled patients with acs, although the target populations were different. In patients with acs excluding stemi treated with fibrinolysis, or lowrisk unstable angina, ticagrelor reduced the risk of death nnt 72 or mi nnt 91 compa. Because of the rigorous application of the bleeding definitions in the plato study, the criteria for major bleeding were fulfilled in 80% of the cabgtreated patients, dr.
Food and drug administration approved ticagrelor in 2011 for reducing thrombotic cardiovascular events in patients with acute coronary syndrome acs with the proviso that it be taken with lowdose aspirin. In the plato study, a reduced response to ticagrelor was observed in north america compared with other regions. United states department of justice closes investigation. Blind study background antiplatelet therapy is essential treatment for acute coronary syndromes acs. Plato enrolled a broad spectrum of patients with acs nsteacs or stemi who were identified within 24 hours after hospitalization for the index event. Similar questions have been responded to by the independent plato executive committee which led the clinical trial. Comparing ticagrelor versus clopidogrel in patients with a. Backgroundaspirin and clopidogrel are recommended for patients with acute coronary. Pdf ticagrelor versus clopidogrel in patients with acute coronary. Comparison of ticagrelor with clopidogrel in patients with a. Ticagrelor in plato and prasugrel in tritontimi 38 and trilogyacs trials in patients with acute coronary syndromes. Ticagrelor brilinta is a reversible, direct acting p2y12 receptor antagonist which prevents adpmediated activation of gpiibiiia receptor complexes thereby reducing platelet aggregation. Replication of ticagrelor versus clopidogrel in patients. By externally validating the conclusions of randomized trials and generating hypotheses for subsequent investigations, such cohort studies have a definite.
Ticagrelor, an oral, reversibly binding platelet p2y 12 receptor inhibitor, yields greater inhibition of platelet aggregation than clopidogrel 1,2 and was shown to reduce the risk of ischaemic events and death compared with clopidogrel in the plato study. Platelet inhibition and patient outcomes plato investigators. If brilinta must be temporarily stopped due to an adverse event, it should be reinitiated as soon as possible when the benefits outweigh the risks of the adverse event or when the adverse event has come to resolution see dosage and administration. Find information about dosage, mechanism of action, and more. The increase in holterdetected ventricular pauses with ticagrelor was higher in patients with chronic heart failure chf than in the overall study population during the acute phase of acs, but not at one month with ticagrelor. Ticagrelor trade name brilinta, brilique, and formerly possia is a platelet aggregation inhibitor produced by astrazeneca ticagrelor is an antagonist of the p2y 12 receptor the drug was approved for use in.
In the platelet inhibition and patient outcomes plato trial, ticagrelor versus clopidogrel reduced the primary endpoint of death from vascular causes, myocardial infarction, or stroke after acs, but increased the incidence of dyspnea, which may lead clinicians to withhold ticagrelor. At 12 months, the ticagrelor group had lower rates of cv death, mi, or stroke than clopidogrel 9. James s1, angiolillo dj, cornel jh, erlinge d, husted s, kontny f, maya j, nicolau jc, spinar j, storey rf, stevens sr, wallentin l. The plato trial was a phase 3, randomized, doubleblind, parallelgroup, multinational, clinical study comparing the efficacy of ticagrelor formerly known as azd6140, marketed as brilinta versus. The trial compared headtohead the efficacy of the experimental antiplatelet agent ticagrelor formerly known as azd6140, to be marketed as. In this study, ticagrelor was not more effective than clopidogrel and was less safe, raising questions about the superiority of ticagrelor for patients undergoing pci for acs. It was recommended that study drugs be withheld in patients undergoing coronary artery bypass graft, 5 days for clopidogrel study drug and 24 to 72 hours for ticagrelor study drug, while maintaining the study blind. Comparison ticagrelor clopidogrel patients a planned. Ticagrelor versus clopidogrel in patients with acute coronary. There are many potential reasons for this study s discordance with plato, including study design, study. Background ticagrelor is an oral, reversible, directacting inhibitor of the adenosine diphosphate receptor p2y12. Ticagrelor has been linked to rare instances of hypersensitivity reactions accompanied by mild liver injury. Comparison of ticagrelor with clopidogrel in patients with a planned invasive strategy for acute coronary syndromes plato.
Outcomes in patients with a planned invasive strategy. Ticagrelor added to aspirin in patients with stable. Based on results of the plato platelet inhibition and patient outcomes trial comparing ticagrelor with clopidogrel therapy, the u. One patient was randomized to placebo but only received ticagrelor tablets. Compare with clopidogrel brilinta ticagrelor tablets. Plato was a large 18,624 patients in 43 countries, headtohead patient outcomes study of brilinta vs. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. Ticagrelor may not be superior to clopidogrel in the real.
Ticagrelor tablets brilique effectiveness ticagrelor is an oral antagonist at the p2y12 adenosine diphosphate receptor, which inhibits platelet aggregation and thrombus formation in atherosclerotic disease. When effects were examined by region, the subanalysis of plato patients from the u. Official health care professional site for brilinta ticagrelor tablets, indicated to reduce the rate of cv death, mi, and stroke in patients with acute coronary syndrome acs. Background ticagrelor is an oral, reversible, directacting inhibitor of the adenosine diphosphate. Ticagrelor for the treatment of acute coronary syndromes ta236. Vol 375 january 23, 2010 283 comparison of ticagrelor with clopidogrel in patients with a planned invasive strategy for acute coronary syndromes plato. This study challenges the results of the landmark plato invasive trial and current guidelines supporting the preference of ticagrelor or prasugrel over clopidogrel in patients with acs. The characteristics of study patients differed between plato, tritontimi 38, and trilogyacs. The 2009 platelet inhibition and patient outcomes plato trial randomized 18,624 patients with acs 37.
Food and drug administration approved ticagrelor in 2011. It is indicated for the management of patients with acute coronary syndrome. Plato was a large 18,624 patients in 43 countries, headtohead patient outcomes study of brilinta. The aim of the present study was to explore the effect of ticagrelor vs. Ticagrelor vs clopidogrel after fibrinolytic therapy in. Patients were eligible for the study if they were hospitalized for acs with or without stsegment. The drug was approved for use in the european union by the european medicines agency on december 3, 2010. In plato, patients on brilinta had a higher risk of hyperuricemia. Ticagrelor compared with clopidogrel in patients with acute coronary syndromes the platelet inhibition and patient outcomes trial.
The plato study compared brilique ticagrelor 180mg loading dose, 90mg twice daily thereafter and clopidogrel 300mg to 600mg loading dose, 75 mg daily thereafter for the prevention of. Fda approval was based on results of the plato study which showed that ticagrelor was superior to clopidogrel in reducing the. United states department of justice closes investigation into. The plato trial was a phase 3, randomized, doubleblind, parallelgroup, multinational, clinical study comparing the efficacy of ticagrelor formerly known as azd6140, marketed as brilinta versus standard care treatment with clopidogrel. Ticagrelor brilinta drug monograph addendum ticagrelor brilinta. The entire plato trial was performed in 18,000 patients, so the genetic material was from more than half of the trial participants.
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