{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,8,2]],"date-time":"2025-08-02T04:23:13Z","timestamp":1754108593200,"version":"3.40.5"},"reference-count":23,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2021,8,8]],"date-time":"2021-08-08T00:00:00Z","timestamp":1628380800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004325","name":"AstraZeneca","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004325","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Cardiology"],"published-print":{"date-parts":[[2021,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>Clinical guidelines recommend extended treatment with dual antiplatelet therapy (DAPT) with ticagrelor 60\u2009mg (twice daily) beyond 12\u2009months in high\u2010risk patients with a history of myocardial infarction (MI) who have previously tolerated DAPT and are not at heightened bleeding risk. However, evidence on patterns of use and associated clinical outcomes in routine clinical practice is limited.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>ALETHEIA is an observational, multi\u2010country study, designed to describe characteristics, treatment persistence, and bleeding and cardiovascular (CV) outcomes in post\u2010MI patients who initiate ticagrelor 60\u2009mg in routine clinical practice (NCT04568083). The study will include electronic health data in the United States (US; Medicare, commercial claims) and Europe (Sweden, Italy, United Kingdom, Germany). Characteristics will be described among patients with and without ticagrelor 60\u2009mg \u22651\u00a0year post\u2010MI. Assuming an a priori threshold of 5000 person\u2010years on\u2010treatment is met, to ensure sufficient precision, clinical outcomes (bleeding and CV events) among patients treated with ticagrelor 60\u2009mg will be assessed. Risk factors for clinical outcomes and treatment discontinuation will be assessed in patients with ticagrelor 60\u2009mg and meta\u2010analysis used to combine estimates across databases. Cohort selection will initiate from the ticagrelor 60\u2009mg US and European approval dates and end February 2020. An estimated total of 7250 patients prescribed ticagrelor 60\u2009mg are expected to be included.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>An increased understanding of patterns of ticagrelor 60\u2009mg use and associated clinical outcomes among high\u2010risk patients with a prior MI is needed. The a priori specified stepwise approach adapted in this observational study is expected to generate useful evidence for clinical decision\u2010making and treatment optimization.<\/jats:p><\/jats:sec>","DOI":"10.1002\/clc.23702","type":"journal-article","created":{"date-parts":[[2021,8,8]],"date-time":"2021-08-08T19:19:50Z","timestamp":1628450390000},"page":"1333-1343","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Extended dual antiplatelet therapy with ticagrelor 60\u2009mg in patients with prior myocardial infarction: The design of <scp>ALETHEIA<\/scp>, a multi\u2010country observational study"],"prefix":"10.1002","volume":"44","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2198-4382","authenticated-orcid":false,"given":"Eva","family":"Les\u00e9n","sequence":"first","affiliation":[{"name":"BioPharmaceuticals Medical, AstraZeneca  Gothenburg Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christopher","family":"Hewitt","sequence":"additional","affiliation":[{"name":"BioPharmaceuticals Medical, AstraZeneca  Cambridge UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Evangelos","family":"Giannitsis","sequence":"additional","affiliation":[{"name":"University of Heidelberg  Heidelberg Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jonatan","family":"Hedberg","sequence":"additional","affiliation":[{"name":"BioPharmaceuticals Medical, AstraZeneca  Gothenburg Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tomas","family":"Jernberg","sequence":"additional","affiliation":[{"name":"Department of Clinical Sciences Danderyd Hospital, Karolinska Institute  Stockholm Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dimitra","family":"Lambrelli","sequence":"additional","affiliation":[{"name":"Real\u2010World Evidence, Evidera Inc.  London UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2764-6779","authenticated-orcid":false,"given":"Aldo P.","family":"Maggioni","sequence":"additional","affiliation":[{"name":"ANMCO Research Center  Florence Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jason C.","family":"Simeone","sequence":"additional","affiliation":[{"name":"Real\u2010World Evidence, Evidera Inc.  Waltham Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0819-6656","authenticated-orcid":false,"given":"Albert","family":"Ariza\u2010Sol\u00e9","sequence":"additional","affiliation":[{"name":"Hospital Universitari de Bellvitge  Barcelona Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert F.","family":"Storey","sequence":"additional","affiliation":[{"name":"Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield  Sheffield UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jurrien","family":"ten Berg","sequence":"additional","affiliation":[{"name":"St Antonius Center for Platelet Function Studies, St Antonius Hospital  Nieuwegein Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marc","family":"Bonaca","sequence":"additional","affiliation":[{"name":"University of Colorado Anschutz School of Medicine, CPC Clinical Research\/CPC Community Health  Aurora Colorado USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"ALETHEIA study team","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2021,8,8]]},"reference":[{"issue":"7","key":"e_1_2_7_2_1","first-page":"e9349","article-title":"Global epidemiology of ischemic heart disease: results from the global burden of disease study","volume":"12","author":"Khan MA","year":"2020","journal-title":"Cureus"},{"doi-asserted-by":"publisher","key":"e_1_2_7_3_1","DOI":"10.1093\/eurheartj\/ehu505"},{"doi-asserted-by":"publisher","key":"e_1_2_7_4_1","DOI":"10.1002\/rth2.12115"},{"issue":"6","key":"e_1_2_7_5_1","first-page":"352","article-title":"Comparative review of oral P2Y12 inhibitors","volume":"43","author":"Koski R","year":"2018","journal-title":"P T"},{"doi-asserted-by":"publisher","key":"e_1_2_7_6_1","DOI":"10.1056\/NEJMoa1409312"},{"doi-asserted-by":"publisher","key":"e_1_2_7_7_1","DOI":"10.1056\/NEJMoa1500857"},{"doi-asserted-by":"publisher","key":"e_1_2_7_8_1","DOI":"10.1016\/j.carrev.2016.07.006"},{"doi-asserted-by":"publisher","key":"e_1_2_7_9_1","DOI":"10.1093\/eurheartj\/ehz425"},{"doi-asserted-by":"publisher","key":"e_1_2_7_10_1","DOI":"10.1161\/CIR.0000000000000404"},{"doi-asserted-by":"publisher","key":"e_1_2_7_11_1","DOI":"10.1093\/eurheartj\/ehx419"},{"doi-asserted-by":"publisher","key":"e_1_2_7_12_1","DOI":"10.1097\/FJC.0000000000000856"},{"doi-asserted-by":"publisher","key":"e_1_2_7_13_1","DOI":"10.2147\/JMDH.S160029"},{"volume-title":"Framework for FDA's Real\u2010World Evidence Program","year":"2018","author":"US FDA","key":"e_1_2_7_14_1"},{"doi-asserted-by":"publisher","key":"e_1_2_7_15_1","DOI":"10.1002\/cpt.1638"},{"doi-asserted-by":"publisher","key":"e_1_2_7_16_1","DOI":"10.1093\/ehjcvp\/pvz020"},{"unstructured":"Ticagrelor [SmPC]. Brilique 60 mg: Summary of product characteristics.2019.","key":"e_1_2_7_17_1"},{"doi-asserted-by":"publisher","key":"e_1_2_7_18_1","DOI":"10.1093\/eurheartj\/ehv531"},{"doi-asserted-by":"publisher","key":"e_1_2_7_19_1","DOI":"10.1016\/j.jacc.2017.07.768"},{"doi-asserted-by":"publisher","key":"e_1_2_7_20_1","DOI":"10.1002\/sim.1186"},{"doi-asserted-by":"publisher","key":"e_1_2_7_21_1","DOI":"10.1001\/jamacardio.2016.1017"},{"doi-asserted-by":"publisher","key":"e_1_2_7_22_1","DOI":"10.1056\/NEJMoa1908419"},{"issue":"6","key":"e_1_2_7_23_1","first-page":"1131","article-title":"Usefulness of health registers for detection of bleeding events in outcome studies","volume":"116","author":"Friberg L","year":"2016","journal-title":"Thromb Haemost"},{"doi-asserted-by":"publisher","key":"e_1_2_7_24_1","DOI":"10.1186\/1471-2458-11-450"}],"container-title":["Clinical Cardiology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/clc.23702","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/clc.23702","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/clc.23702","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,29]],"date-time":"2023-08-29T23:36:27Z","timestamp":1693352187000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/clc.23702"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,8,8]]},"references-count":23,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2021,10]]}},"alternative-id":["10.1002\/clc.23702"],"URL":"https:\/\/doi.org\/10.1002\/clc.23702","archive":["Portico"],"relation":{},"ISSN":["0160-9289","1932-8737"],"issn-type":[{"type":"print","value":"0160-9289"},{"type":"electronic","value":"1932-8737"}],"subject":[],"published":{"date-parts":[[2021,8,8]]},"assertion":[{"value":"2021-04-29","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-07-19","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-08-08","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}