Terutroban versus aspirin in patients with cerebral ischaemic events (PERFORM): a randomised, double-blind, parallel-group trial
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Authors
Bousser, Marie-GermaineAmarenco, Pierre
Chamorro, Angel
Fisher, Marc
Ford, Ian
Fox, Kim M.
Hennerici, Michael G.
Mattle, Heinrich P.
Rothwell, Peter M.
de Cordoue, Agnes
Fratacci, Marie-Dominique
UMass Chan Affiliations
Department of NeurologyDocument Type
Journal ArticlePublication Date
2011-06-11Keywords
AgedAspirin
Double-Blind Method
Female
Humans
Ischemic Attack, Transient
Male
Middle Aged
Naphthalenes
Platelet Aggregation Inhibitors
Propionic Acids
Receptors, Thromboxane
*Secondary Prevention
Stroke
Treatment Outcome
Neurology
Neuroscience and Neurobiology
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Show full item recordAbstract
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 endpoint with terutroban and aspirin, without safety advantages for terutroban. In a worldwide perspective, aspirin remains the gold standard antiplatelet drug for secondary stroke prevention in view of its efficacy, tolerance, and cost. FUNDING: Servier, France.Source
Lancet. 2011 Jun 11;377(9782):2013-22. Epub 2011 May 25. Link to article on publisher's site
DOI
10.1016/S0140-6736(11)60600-4Permanent Link to this Item
http://hdl.handle.net/20.500.14038/37731PubMed ID
21616527Related Resources
Link to Article in PubMedae974a485f413a2113503eed53cd6c53
10.1016/S0140-6736(11)60600-4