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Statements

Subject Item
n2:RIV%2F00843989%3A_____%2F11%3A00101955%21RIV12-MZ0-00843989
rdf:type
n7:Vysledek skos:Concept
dcterms:description
Background Patients with ischaemic stroke or transient ischaemic attack (TIA) are at high risk of recurrent stroke or other cardiovascular events. We compared the selective thromboxane-prostaglandin receptor antagonist terutroban with aspirin in the prevention of cerebral and cardiovascular ischaemic events in patients with a recent non-cardioembolic cerebral ischaemic event. Methods This randomised, double-blind, parallel-group trial was undertaken in 802 centres in 46 countries. Patients who had an ischaemic stroke in the previous 3 months or a TIA in the previous 8 days were randomly allocated with a central interactive response system to 30 mg per day terutroban or 100 mg per day aspirin. Patients and investigators were masked to treatment allocation. The primary efficacy endpoint was a composite of fatal or non-fatal ischaemic stroke, fatal or non-fatal myocardial infarction, or other vascular death (excluding haemorrhagic death). We planned a sequential statistical analysis of non-inferiority (margin 1.05) followed by analysis of superiority. Analysis was by intention to treat. The study was stopped prematurely for futility on the basis of the recommendation of the Data Monitoring Committee. This study is registered, number ISRCTN66157730. Findings 9562 patients were assigned to terutroban (9556 analysed) and 9558 to aspirin (9544 analysed); mean follow-up was 28-3 months (SD 7.7). The primary endpoint occurred in 1091 (11%) patients receiving terutroban and 1062 (11%) receiving aspirin (hazard ratio [HR.] 1.02, 95% CI 0.94-1.12). There was no evidence of a difference between terutroban and aspirin for the secondary or tertiary endpoints. We recorded some increase in minor bleedings with terutroban compared with aspirin (1147 [12%] vs 1045 [11%]; HR 1.11, 95% CI 1.02-1.21), but no significant differences in other safety endpoints. Interpretation The trial did not meet the predefined criteria for non-inferiority, but showed similar rates of the primary endpo... Background Patients with ischaemic stroke or transient ischaemic attack (TIA) are at high risk of recurrent stroke or other cardiovascular events. We compared the selective thromboxane-prostaglandin receptor antagonist terutroban with aspirin in the prevention of cerebral and cardiovascular ischaemic events in patients with a recent non-cardioembolic cerebral ischaemic event. Methods This randomised, double-blind, parallel-group trial was undertaken in 802 centres in 46 countries. Patients who had an ischaemic stroke in the previous 3 months or a TIA in the previous 8 days were randomly allocated with a central interactive response system to 30 mg per day terutroban or 100 mg per day aspirin. Patients and investigators were masked to treatment allocation. The primary efficacy endpoint was a composite of fatal or non-fatal ischaemic stroke, fatal or non-fatal myocardial infarction, or other vascular death (excluding haemorrhagic death). We planned a sequential statistical analysis of non-inferiority (margin 1.05) followed by analysis of superiority. Analysis was by intention to treat. The study was stopped prematurely for futility on the basis of the recommendation of the Data Monitoring Committee. This study is registered, number ISRCTN66157730. Findings 9562 patients were assigned to terutroban (9556 analysed) and 9558 to aspirin (9544 analysed); mean follow-up was 28-3 months (SD 7.7). The primary endpoint occurred in 1091 (11%) patients receiving terutroban and 1062 (11%) receiving aspirin (hazard ratio [HR.] 1.02, 95% CI 0.94-1.12). There was no evidence of a difference between terutroban and aspirin for the secondary or tertiary endpoints. We recorded some increase in minor bleedings with terutroban compared with aspirin (1147 [12%] vs 1045 [11%]; HR 1.11, 95% CI 1.02-1.21), but no significant differences in other safety endpoints. Interpretation The trial did not meet the predefined criteria for non-inferiority, but showed similar rates of the primary endpo...
dcterms:title
Terutroban versus aspirin in patients with cerebral ischaemic events (PERFORM): a randomised, double-blind, parallel-group trial Terutroban versus aspirin in patients with cerebral ischaemic events (PERFORM): a randomised, double-blind, parallel-group trial
skos:prefLabel
Terutroban versus aspirin in patients with cerebral ischaemic events (PERFORM): a randomised, double-blind, parallel-group trial Terutroban versus aspirin in patients with cerebral ischaemic events (PERFORM): a randomised, double-blind, parallel-group trial
skos:notation
RIV/00843989:_____/11:00101955!RIV12-MZ0-00843989
n7:predkladatel
n17:ico%3A00843989
n3:aktivita
n13:S n13:N
n3:aktivity
N, S
n3:cisloPeriodika
9782
n3:dodaniDat
n8:2012
n3:domaciTvurceVysledku
n18:1669079
n3:druhVysledku
n15:J
n3:duvernostUdaju
n9:S
n3:entitaPredkladatele
n16:predkladatel
n3:idSjednocenehoVysledku
234851
n3:idVysledku
RIV/00843989:_____/11:00101955
n3:jazykVysledku
n14:eng
n3:klicovaSlova
placebo-controlled trial; high-risk patients; receptor antagonist; thromboxane A(2); cardiovascular events; myocardial-infarction; coronary angioplasty; attack PERFORM; stroke; prevention
n3:klicoveSlovo
n4:prevention n4:myocardial-infarction n4:stroke n4:attack%20PERFORM n4:thromboxane%20A%282%29 n4:high-risk%20patients n4:receptor%20antagonist n4:placebo-controlled%20trial n4:coronary%20angioplasty n4:cardiovascular%20events
n3:kodStatuVydavatele
GB - Spojené království Velké Británie a Severního Irska
n3:kontrolniKodProRIV
[1FE2DA6FE9D0]
n3:nazevZdroje
The lancet
n3:obor
n10:FH
n3:pocetDomacichTvurcuVysledku
1
n3:pocetTvurcuVysledku
810
n3:rokUplatneniVysledku
n8:2011
n3:svazekPeriodika
377
n3:tvurceVysledku
Bousser, M. G. Amarenco, P. Ford, I. Fisher, M. Fratacci, M. D. de Cordoüe, A. Mattle, H. P. Chamorro, A. Rothwell, P. M. Bar, Michal Fox, K. M. Hennerici, M. G.
n3:wos
000292011700036
s:issn
0140-6736
s:numberOfPages
10
n5:doi
10.1016/S0140-6736(11)60600-4