The tritontimi 38 trial to assess improvement in therapeutic outcomes by optimizing platelet inhibition with prasugrelthrombolysis in myocardial infarction trial demonstrated that a prasugrel regimen of a loading dose of 60 mg and daily maintenance dose of 10 mg was significantly superior to the standard regimen of clopidogrel 300mg. That is, this study was a secondary analysis that utilized summary relative risk rr estimates that have been previously reported rather than individual patient data from the triton. Genetic variants in abcb1 and cyp2c19 and cardiovascular. Prasugrel compared with clopidogrel in patients undergoing percutaneous coronary intervention for stelevation myocardial infarction tritontimi. The tritontimi 38 trial was supported by a research grant to the brigham and womens hospital from daiichi sankyo co. In triton timi 38, patients with acute coronary syndromes were treated with prasugrel or clopidogrel, with aspirin, for a median of 14. Tritontimi 38 trial outcome data the analyses comprising this study were based exclusively on published results of the tritontimi 38 trial.
Prasugrel effient stemi subgroup analysis published in. Balancing efficacy and safety in the tritontimi 38 trial. Platelet inhibition with prasugrelthrombolysis in myocardial infarction triton. In the tritontimi 38 trial, greater platelet inhibition with prasugrel reduced the first occurrence of the primary endpoint cardiovascular death, mi, or stroke compared with clopidogrel in patients with an acute coronary syndrome acs undergoing planned percutaneous coronary intervention. The cohort of 448 patients included all those who died and all but 2 patients who were classified in the tritontimi 38 trial as having had timi majorminor bleeding events 1 patient was randomized to prasugrel but did not receive the study medication and 1 patient received clopidogrel.
The new england journal of medicine established in 1812 november 15. Based on this trial, the eu label for prasugrel recommends treatment for up to 12 months and excludes patients with prior stroketransient ischemic attack tia. Mortality benefit with prasugrel in the tritontimi 38. The tritontimi 38 trial was supported by a research grant to the brigham and womens hospital. Primary pci was defined as within 12 h of symptom onset. Evaluation of prasugrel compared with clopidogrel in. The tritontimi 38 5 study was designed to evaluate the efficacy and safety of prasugrel compared with clopidogrel in moderatetohighrisk patients with acute coronary syndromes undergoing percutaneous coronary intervention pci on a background of aspirin. Tritontimi 38 is a phase 3 comparison of prasugrel versus clopidogrel in patients with moderate to highrisk acs undergoing pci. Design and rationale for the trial to assess improvement in therapeutic outcomes by optimizing platelet inhibition with prasugrel thrombolysis in myocardial infarction 38 tritontimi 38. Timi 38 trial demonstrated that prasugrel, a novel and potent thienopyridine. Montalescot g, wiviott sd, braunwald e, murphy sa, gibson cm, mccabe ch, antman em.
Evaluation of prasugrel compared with clopidogrel in patients with acute coronary syndromes. Paper reporting an analysis of the association between abcb1 3435ct and reduced function alleles of cyp2c19 n 2932 patients and clinical outcomes in the triton timi 38 trial. Prasugrel effient vs clopidogrel plavix in patients with acs 1 trial to assess improvement in therapeutic outcomes by optimizing platelet inhibition with prasugrel. Triton timi 38 evaluated prasugrel compared with clopidogrel in patients with acute coronary syndromes. In gilles montalescot and colleagues report on the subgroup with stsegmentelevation myocardial infarction stemi from tritontimi 38 feb 28, p 723,1 nonfatal myocardial infarction was not adequately defined. Triton timi 38 was designed as a collaboration between the timi study group, the sponsors daiichi sankyo and eli lilly and a steering committee of investigators see the appendix. Publications related to the tritontimi 38 trial prasugrel efient. Pharmacodynamic assessment of platelet inhibition by prasugrel vs.
Methods the study design and principal results from the pivotal phase iii. Ticagrelor in plato and prasugrel in tritontimi 38. The inclusion criteria for patients with unstable angina or nonstelevation myocardial infarction were ischemic symptoms lasting 10 minutes or more and occurring. A comparison of prasugrel cs747 and clopidogrel in. Of note, subsequent to the tritontimi 38 study, the trilogy trial. Paper reporting an analysis of the association between abcb1 3435ct and reduced. An analysis of tritontimi 38, based on the 12 month. Efficacy and safety of ticagrelor in comparison to. Tritontimi 38, 2007 trial summary pdf trial summary a randomised clinical trial investigating the effect of prasugrel versus clopidogrel on top aspirin in patients with moderatetohighrisk acute coronary syndromes ua, nstemi,stemi with scheduled percutaneous coronary intervention. However, elderly patients were underrepresented in the triton timi 38 trial to assess improvement in therapeutic outcomes by optimizing platelet inhibition with prasugrelthrombolysis in myocardial infarction 38 and plato trials, composing only % and 15% of the study populations, respectively. Replication of prasugrel versus clopidogrel in patients. Triton timi 38, a phase 3 trial involving patients with acute coronary syndromes with scheduled pci. Pdf reduction in recurrent cardiovascular events with.
Prasugrel effient vs clopidogrel plavix in patients with acs 1 trial to assess improvement in therapeutic outcomes by optimizing platelet inhibition with prasugrel thrombolysis in myocardial infarction. The analyses comprising this study were based exclusively on published results of the triton. Methods stemi patients in the tritontimi 38 trial to assess improvement in therapeutic outcomes by optimizing platelet inhibition with prasugrelthrombolysis in myocardial infarction 38 were randomized to prasugrel or clopidogrel on presentation if primary pci was intended or later during secondary pci. Tritontimi 38 was designed as a collaboration between the timi study group, the sponsors daiichi sankyo and eli lilly and a steering committee of investigators see the appendix. Is prasugrel superior to clopidogrel for patients with. Trial to assess improvement in therapeutic outcomes by optimizing platelet inhibition with prasugrel triton timi 38 disclosure statement. Prasugrelthrombolysis in myocardial infarction 38 tritontimi 38. The goal of the current analysis was to provide additional information to facilitate the assessment of risk bene. Tritontimi 38 was a randomized, phase iii trial, conducted across 30 countries from november 2004 to january 2007. Early and late benefits of prasugrel in patients with.
In the tritontimi 38 trial, greater platelet inhibition with prasugrel reduced the first occurrence of the primary endpoint cardiovascular death, mi, or stroke compared with clopidogrel in. The tritontimi 38 trial randomized,608 patients with moderatetohighrisk acs with scheduled percutaneous coronary intervention pci. Trial to assess improvement in therapeutic outcomes by optimizing. Benefits for specific subpopulations in tritontimi 38 oxford. Transcript tritontimi 38 tritontimi 38 intensive oral antiplatelet therapy for reduction of ischaemic events including stent thrombosis in patients with acute coronary syndromes treated with percutaneous coronary intervention and stenting in the tritontimi 38 trial. The results of the triton timi 38 study15 showed higher incidences of major adverse cardiovascular and bleeding events with prasugrel than with clopidogrel in this subgroup of patients. Prasugrel versus clopidogrel in patients with acute coronary syndromes tritontimi 38 trial 1. Prasugrel versus clopidogrel in patients with stsegment. Timi 38, a phase 3 trial involving patients with acute coronary syndromes with scheduled pci. This outcome drove most of the reduction in the primary composite endpoint seen with prasugrel versus clopidogrel. A subset of the tritontimi 38 study trial to assess improvement in therapeutic outcomes by optimizing.
Benefits for specific subpopulations in tritontimi 38. The triton timi 38 trial was supported by a research grant to the brigham and womens hospital from daiichi sankyo co. Tritontimi 38 trial to assess improvement in therapeuticoutcomes by optimizing platelet inhibition with prasugrelthrombolysis in myocardial infarctions wiviott brigham and womens hospital, boston, maamerican heart association 2007 scientific sessions population and treatment. Comparison of prasugrel and clopidogrel in patients with.
Stemi patients in the tritontimi 38 trial to assess improvement in therapeutic outcomes by optimizing platelet inhibition with prasugrelthrombolysis in myocardial infarction 38 were randomized to prasugrel or clopidogrel on presentation if primary pci. About tritontimi 38 the main tritontimi 38 clinical trial, previously published in the new england journal of medicine in november 2007 vol. To avoid such bleeding complications, prasugrel at 375 mgday, approximately onethird of the approved. In triton timi 38 trial to assess improvement in therapeutic outcomes by optimizing platelet inhibition with prasugrelthrombolysis in myocardial infarction 38, prasugrel was associated with an increased risk of cabgrelated bleeding compared to clopidogrel. In tritontimi 38, patients with moderate to highrisk acs 74% nsteacs. Clinical outcomes for prasugrel versus clopidogrel in. Prasugrel versus clopidogrel in patients with acute coronary. The definite or probable stent thrombosis rate in the triton timi 38 trial in the clopidogrel group at 15 months was 2. All patients were scheduled to undergo percutaneous coronary intervention pci. Prasugrel versus clopidogrel in patients with acute. The trial to assess improvement in therapeutic outcomes by optimizing platelet inhibition with prasugrelthrombolysis in myocardial infarction 38 tritontimi 38 study was a phase 3, multicenter.
The tritontimi 38 trial randomized,608 patients with moderatetohighrisk acs with scheduled percutaneous coronary intervention pci to prasugrel 60 mg loading dose, 10 mgd maintenance dose or clopidogrel 300 mg loading dose, 75 mgd maintenance dose. The tritontimi 38 study tested the hypothesis that prasugrel compared with clopi. Trial to assess improvement in therapeutic outcomes by optimizing platelet inhibition with prasugrel tritontimi 38 disclosure statement. Balancing efficacy and safety in the tritontimi 38 trial oxford. In addition, it is the first largescale clinical events trial to assess whether a thienopyridine regimen that achieves a higher level of inhibition of platelet aggregation than the standard therapy. Investigators of the tritontimi 38 trial, which compared prasugrel with clopidogrel in acs patients undergoing elective or urgent pci, found that higher inhibition of platelet activity was. That is, this study was a secondary analysis that utilized summary relative risk rr estimates that have been previously reported rather than individual patient data from the tritontimi 38 trial.
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