Terutroban versus aspirin in patients with cerebral ischaemic events (PERFORM): a randomised, double-blind, parallel-group trial
Summary 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...
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| Veröffentlicht in: | LANCET 2011-06, Vol.377 (9782), p.2013-2022 |
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| creator | Bousser, Marie-Germaine, Prof Amarenco, Pierre, Prof Chamorro, Angel, Prof Fisher, Marc, Prof Ford, Ian, MD Fox, Kim M, Prof Hennerici, Michael G, Prof Mattle, Heinrich P, Prof Rothwell, Peter M, Prof de Cordoüe, Agnès, MD Fratacci, Marie-Dominique, MD |
| description | Summary 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. |
| doi_str_mv | 10.1016/S0140-6736(11)60600-4 |
| format | Article |
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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.</description><identifier>ISSN: 0140-6736</identifier><identifier>EISSN: 1474-547X</identifier><identifier>DOI: 10.1016/S0140-6736(11)60600-4</identifier><identifier>PMID: 21616527</identifier><identifier>CODEN: LANCAO</identifier><language>eng</language><publisher>Kidlington: Elsevier Ltd</publisher><subject>Acute coronary syndromes ; Aged ; antagonists ; Aspirin ; Aspirin - therapeutic use ; Biological and medical sciences ; Bleeding ; Blood clots ; Blood pressure ; Clinical trials ; Data processing ; death ; Dementia ; Double-Blind Method ; Drugs ; Female ; General aspects ; Heart attacks ; Human health and pathology ; Humans ; Internal Medicine ; Ischemic Attack, Transient ; Ischemic Attack, Transient - drug therapy ; Ischemic Attack, Transient - prevention & control ; Life Sciences ; Male ; Medical sciences ; Middle Aged ; monitoring ; Mortality ; Motivation ; Myocardial infarction ; Naphthalenes ; Naphthalenes - therapeutic use ; patients ; Platelet Aggregation Inhibitors ; Platelet Aggregation Inhibitors - therapeutic use ; Prevention ; Propionates ; Propionates - therapeutic use ; Receptors, Thromboxane ; Receptors, Thromboxane - antagonists & inhibitors ; risk ; Risk factors ; Secondary Prevention ; Statistical analysis ; Stroke ; Stroke - drug therapy ; Stroke - prevention & control ; Studies ; Transient ischemic attack ; Treatment Outcome</subject><ispartof>LANCET, 2011-06, Vol.377 (9782), p.2013-2022</ispartof><rights>Elsevier Ltd</rights><rights>2011 Elsevier Ltd</rights><rights>2015 INIST-CNRS</rights><rights>Copyright © 2011 Elsevier Ltd. All rights reserved.</rights><rights>Copyright Elsevier Limited Jun 11-Jun 17, 2011</rights><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c605t-860847e75b47d84f355e86c8579ecba1827b5a3b4a97e48e759128bb3a99bdef3</citedby><cites>FETCH-LOGICAL-c605t-860847e75b47d84f355e86c8579ecba1827b5a3b4a97e48e759128bb3a99bdef3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/871534950?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>230,314,776,780,881,3536,27903,27904,64361,64363,64365,65309,72215</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=24249412$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21616527$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://unilim.hal.science/hal-00771537$$DView record in HAL$$Hfree_for_read</backlink><backlink>$$Uhttp://kipublications.ki.se/Default.aspx?queryparsed=id:122824323$$DView record from Swedish Publication Index$$Hfree_for_read</backlink></links><search><creatorcontrib>Bousser, Marie-Germaine, Prof</creatorcontrib><creatorcontrib>Amarenco, Pierre, Prof</creatorcontrib><creatorcontrib>Chamorro, Angel, Prof</creatorcontrib><creatorcontrib>Fisher, Marc, Prof</creatorcontrib><creatorcontrib>Ford, Ian, MD</creatorcontrib><creatorcontrib>Fox, Kim M, Prof</creatorcontrib><creatorcontrib>Hennerici, Michael G, Prof</creatorcontrib><creatorcontrib>Mattle, Heinrich P, Prof</creatorcontrib><creatorcontrib>Rothwell, Peter M, Prof</creatorcontrib><creatorcontrib>de Cordoüe, Agnès, MD</creatorcontrib><creatorcontrib>Fratacci, Marie-Dominique, MD</creatorcontrib><creatorcontrib>on behalf of the PERFORM Study Investigators</creatorcontrib><creatorcontrib>PERFORM Study Investigators</creatorcontrib><title>Terutroban versus aspirin in patients with cerebral ischaemic events (PERFORM): a randomised, double-blind, parallel-group trial</title><title>LANCET</title><addtitle>Lancet</addtitle><description>Summary 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.</description><subject>Acute coronary syndromes</subject><subject>Aged</subject><subject>antagonists</subject><subject>Aspirin</subject><subject>Aspirin - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Bleeding</subject><subject>Blood clots</subject><subject>Blood pressure</subject><subject>Clinical trials</subject><subject>Data processing</subject><subject>death</subject><subject>Dementia</subject><subject>Double-Blind Method</subject><subject>Drugs</subject><subject>Female</subject><subject>General aspects</subject><subject>Heart attacks</subject><subject>Human health and pathology</subject><subject>Humans</subject><subject>Internal Medicine</subject><subject>Ischemic Attack, Transient</subject><subject>Ischemic Attack, Transient - drug therapy</subject><subject>Ischemic Attack, Transient - prevention & control</subject><subject>Life Sciences</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>monitoring</subject><subject>Mortality</subject><subject>Motivation</subject><subject>Myocardial infarction</subject><subject>Naphthalenes</subject><subject>Naphthalenes - therapeutic use</subject><subject>patients</subject><subject>Platelet Aggregation Inhibitors</subject><subject>Platelet Aggregation Inhibitors - therapeutic use</subject><subject>Prevention</subject><subject>Propionates</subject><subject>Propionates - therapeutic use</subject><subject>Receptors, Thromboxane</subject><subject>Receptors, Thromboxane - antagonists & inhibitors</subject><subject>risk</subject><subject>Risk factors</subject><subject>Secondary Prevention</subject><subject>Statistical analysis</subject><subject>Stroke</subject><subject>Stroke - drug therapy</subject><subject>Stroke - prevention & control</subject><subject>Studies</subject><subject>Transient ischemic attack</subject><subject>Treatment 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and Cancer Research Abstracts</collection><collection>SciTech Premium Collection</collection><collection>British Nursing Index</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>ProQuest Newsstand Professional</collection><collection>ProQuest Biological Science Collection</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>ProQuest Psychology</collection><collection>Research Library</collection><collection>Science Database</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biological Science Database</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><collection>SIRS Editorial</collection><collection>MEDLINE - Academic</collection><collection>Hyper Article en Ligne (HAL)</collection><collection>SwePub</collection><collection>SwePub Articles</collection><jtitle>LANCET</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Bousser, Marie-Germaine, Prof</au><au>Amarenco, Pierre, Prof</au><au>Chamorro, Angel, Prof</au><au>Fisher, Marc, Prof</au><au>Ford, Ian, MD</au><au>Fox, Kim M, Prof</au><au>Hennerici, Michael G, Prof</au><au>Mattle, Heinrich P, Prof</au><au>Rothwell, Peter M, Prof</au><au>de Cordoüe, Agnès, MD</au><au>Fratacci, Marie-Dominique, MD</au><aucorp>on behalf of the PERFORM Study Investigators</aucorp><aucorp>PERFORM Study Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Terutroban versus aspirin in patients with cerebral ischaemic events (PERFORM): a randomised, double-blind, parallel-group trial</atitle><jtitle>LANCET</jtitle><addtitle>Lancet</addtitle><date>2011-06-11</date><risdate>2011</risdate><volume>377</volume><issue>9782</issue><spage>2013</spage><epage>2022</epage><pages>2013-2022</pages><issn>0140-6736</issn><eissn>1474-547X</eissn><coden>LANCAO</coden><abstract>Summary 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.</abstract><cop>Kidlington</cop><pub>Elsevier Ltd</pub><pmid>21616527</pmid><doi>10.1016/S0140-6736(11)60600-4</doi><tpages>10</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0140-6736 |
| ispartof | LANCET, 2011-06, Vol.377 (9782), p.2013-2022 |
| issn | 0140-6736 1474-547X |
| language | eng |
| recordid | cdi_hal_primary_oai_HAL_hal_00771537v1 |
| source | MEDLINE; Elsevier ScienceDirect Journals; ProQuest Central UK/Ireland |
| subjects | Acute coronary syndromes Aged antagonists Aspirin Aspirin - therapeutic use Biological and medical sciences Bleeding Blood clots Blood pressure Clinical trials Data processing death Dementia Double-Blind Method Drugs Female General aspects Heart attacks Human health and pathology Humans Internal Medicine Ischemic Attack, Transient Ischemic Attack, Transient - drug therapy Ischemic Attack, Transient - prevention & control Life Sciences Male Medical sciences Middle Aged monitoring Mortality Motivation Myocardial infarction Naphthalenes Naphthalenes - therapeutic use patients Platelet Aggregation Inhibitors Platelet Aggregation Inhibitors - therapeutic use Prevention Propionates Propionates - therapeutic use Receptors, Thromboxane Receptors, Thromboxane - antagonists & inhibitors risk Risk factors Secondary Prevention Statistical analysis Stroke Stroke - drug therapy Stroke - prevention & control Studies Transient ischemic attack Treatment Outcome |
| title | Terutroban versus aspirin in patients with cerebral ischaemic events (PERFORM): a randomised, double-blind, parallel-group trial |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-25T19%3A32%3A41IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_swepu&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Terutroban%20versus%20aspirin%20in%20patients%20with%20cerebral%20ischaemic%20events%20(PERFORM):%20a%20randomised,%20double-blind,%20parallel-group%20trial&rft.jtitle=LANCET&rft.au=Bousser,%20Marie-Germaine,%20Prof&rft.aucorp=on%20behalf%20of%20the%20PERFORM%20Study%20Investigators&rft.date=2011-06-11&rft.volume=377&rft.issue=9782&rft.spage=2013&rft.epage=2022&rft.pages=2013-2022&rft.issn=0140-6736&rft.eissn=1474-547X&rft.coden=LANCAO&rft_id=info:doi/10.1016/S0140-6736(11)60600-4&rft_dat=%3Cproquest_swepu%3E872530853%3C/proquest_swepu%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=871534950&rft_id=info:pmid/21616527&rft_els_id=S0140673611606004&rfr_iscdi=true |