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Antiplatelet therapy with aspirin, clopidogrel, and dipyridamole versus
clopidogrel alone or aspirin and dipyridamole in patients with acute cerebral
ischaemia (TARDIS): a randomised, open-label, phase 3 superiority trial
#MMPMID29274727
Bath PM
; Woodhouse LJ
; Appleton JP
; Beridze M
; Christensen H
; Dineen RA
; Duley L
; England TJ
; Flaherty K
; Havard D
; Heptinstall S
; James M
; Krishnan K
; Markus HS
; Montgomery AA
; Pocock SJ
; Randall M
; Ranta A
; Robinson TG
; Scutt P
; Venables GS
; Sprigg N
Lancet
2018[Mar]; 391
(10123
): 850-859
PMID29274727
show ga
BACKGROUND: Intensive antiplatelet therapy with three agents might be more
effective than guideline treatment for preventing recurrent events in patients
with acute cerebral ischaemia. We aimed to compare the safety and efficacy of
intensive antiplatelet therapy (combined aspirin, clopidogrel, and dipyridamole)
with that of guideline-based antiplatelet therapy. METHODS: We did an
international, prospective, randomised, open-label, blinded-endpoint trial in
adult participants with ischaemic stroke or transient ischaemic attack (TIA)
within 48 h of onset. Participants were assigned in a 1:1 ratio using computer
randomisation to receive loading doses and then 30 days of intensive antiplatelet
therapy (combined aspirin 75 mg, clopidogrel 75 mg, and dipyridamole 200 mg twice
daily) or guideline-based therapy (comprising either clopidogrel alone or
combined aspirin and dipyridamole). Randomisation was stratified by country and
index event, and minimised with prognostic baseline factors, medication use, time
to randomisation, stroke-related factors, and thrombolysis. The ordinal primary
outcome was the combined incidence and severity of any recurrent stroke
(ischaemic or haemorrhagic; assessed using the modified Rankin Scale) or TIA
within 90 days, as assessed by central telephone follow-up with masking to
treatment assignment, and analysed by intention to treat. This trial is
registered with the ISRCTN registry, number ISRCTN47823388. FINDINGS: 3096
participants (1556 in the intensive antiplatelet therapy group, 1540 in the
guideline antiplatelet therapy group) were recruited from 106 hospitals in four
countries between April 7, 2009, and March 18, 2016. The trial was stopped early
on the recommendation of the data monitoring committee. The incidence and
severity of recurrent stroke or TIA did not differ between intensive and
guideline therapy (93 [6%] participants vs 105 [7%]; adjusted common odds ratio
[cOR] 0·90, 95% CI 0·67-1·20, p=0·47). By contrast, intensive antiplatelet
therapy was associated with more, and more severe, bleeding (adjusted cOR 2·54,
95% CI 2·05-3·16, p<0·0001). INTERPRETATION: Among patients with recent cerebral
ischaemia, intensive antiplatelet therapy did not reduce the incidence and
severity of recurrent stroke or TIA, but did significantly increase the risk of
major bleeding. Triple antiplatelet therapy should not be used in routine
clinical practice. FUNDING: National Institutes of Health Research Health
Technology Assessment Programme, British Heart Foundation.
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