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Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/28958

Title: Rationale and design of a prospective substudy of clinical endpoint adjudication processes within an investigator-reported randomised controlled trial in patients with coronary artery disease: the GLOBAL LEADERS Adjudication Sub-StudY (GLASSY)
Authors: Leonardi, Sergio
Franzone, Anna
Piccolo, Raffaele
McFadden, Eugene
Vranckx, Pascal
Serruys, Patrick
Benit, Edouard
Liebetrau, Christoph
Janssens, Luc
Ferrario, Maurizio
Zurakowski, Aleksander
van Geuns, Robert-Jan
Dominici, Marcello
Huber, Kurt
Slagboom, Ton
Buszman, Pawel
Bolognese, Leonardo
Tumscitz, Carlo
Bryniarski, Krzysztof
Aminian, Adel
Vrolix, Mathias
Petrov, Ivo
Garg, Scot
Naber, Christoph
Prokopczuk, Janusz
Hamm, Christian
Steg, Gabriel
Heg, Dik
Juni, Peter
Windecker, Stephan
Valgimigli, Marco
Issue Date: 2019
Publisher: BMJ PUBLISHING GROUP
Citation: BMJ OPEN, 9(3) (Art N° e026053)
Abstract: Introduction The GLOBAL LEADERS is an open-label, pragmatic and superiority randomised controlled trial designed to challenge the current treatment paradigm of dual antiplatelet therapy (DAPT) for 12 months followed by aspirin monotherapy among patients undergoing percutaneous coronary intervention. By design, all study endpoints are investigator reported (IR) and not subject to formal adjudication by an independent Clinical Event Committee (CEC), which may introduce detection, reporting or ascertainment bias. Methods and analysis We designed the GLOBAL LEADERS Adjudication Sub-StudY (GLASSY) to prospectively implement, in a large sample of patients enrolled within the GLOBAL LEADERS trial (7585 of 15 991, 47.5%), an independent adjudication process of reported and unreported potential endpoints, using standardised CEC procedures, in order to assess whether 23-month ticagrelor monotherapy (90 mg twice daily) after 1-month DAPT is non-inferior to a standard regimen of DAPT for 12 months followed by aspirin monotherapy for the primary efficacy endpoint of death, non-fatal myocardial infarction, non-fatal stroke or urgent target vessel revascularisation and superior for the primary safety endpoint of type 3 or 5 bleeding according to the Bleeding Academic Research Consortium criteria. This study will comprehensively assess the comparative safety and efficacy of the two tested antithrombotic strategies on CEC-adjudicated ischaemic and bleeding endpoints and will provide insights into the role of a standardised CEC adjudication process on the interpretation of study findings by quantifying the level of concordance between IR-reported and CEC-adjudicated events. Ethics and dissemination GLASSY has been approved by local ethics committee of all study sites and/or by the central ethics committee for the country depending on country-specific regulations. In all cases, they deemed that it was not necessary to obtain further informed consent from individual subjects.
Notes: [Leonardi, Sergio] Univ Pavia, Fdn IRCCS Policlin San Matteo, Dept Mol Med, Pavia, Italy. [Franzone, Anna; Piccolo, Raffaele] Federico II Univ Naples, Dept Adv Biomed Sci, Naples, Italy. [McFadden, Eugene] Cork Univ Hosp Grp, Dept Cardiol, Cork, Ireland. [Vranckx, Pascal] Hartctr Hasselt, Dept Cardiol & Crit Care Med, Hasselt, Belgium. [Serruys, Patrick] Imperial Coll London, Dept Cardiol, London, England. [Benit, Edouard] Jessa Hosp, Dept Cardiol, Hasselt, Belgium. [Liebetrau, Christoph] Kerckhoff Heart & Thorax Ctr, Dept Cardiol, Bad Nauheim, Germany. [Janssens, Luc] Imelda Hosp, Dept Cardiol, Bonheiden, Belgium. [Ferrario, Maurizio] Fdn IRCCS Policlin San Matteo, Dept Cardiol, Pavia, Italy. [Zurakowski, Aleksander] Amer Heart Poland, Ctr Cardiovasc Res & Dev, Katowice, Poland. [van Geuns, Robert-Jan] Erasmus MC, Dept Cardiol, Rotterdam, Netherlands. [Dominici, Marcello] S Maria Univ Hosp, Dept Cardiol, Terni, Italy. [Huber, Kurt] Wilhelminenhospital, Med Dept 3, Cardiol & Emergency Med, Vienna, Austria. [Slagboom, Ton] OLVG, Dept Cardiol, Amsterdam, Netherlands. [Buszman, Pawel] Amer Heart Poland, Ctr Cardiovasc Res & Dev, Katowice, Poland. [Bolognese, Leonardo] Azienda Toscana USL Sudest, Dept Cardiol, Arezzo, Italy. [Tumscitz, Carlo] Azienda Osped Univ Ferrara Arcispedale St Anna, Dept Cardiol, Cona, Italy. [Bryniarski, Krzysztof] Jagiellonian Univ, Coll Med, John Paul II Hosp, Krakow, Poland. [Aminian, Adel] Ctr Hosp Univ Charleroi, Dept Cardiol, Charleroi, Belgium. [Vrolix, Mathias] Ziekenhuis Oost Limburg, Dept Cardiol, Genk, Belgium. [Petrov, Ivo] Adzhibadem Siti Klin Surdechno Sudovi Ctr, Dept Cardiol, Sofia, Bulgaria. [Garg, Scot] East Lancashire Hosp NHS Trust, Dept Cardiol, Blackburn, Lancs, England. [Naber, Christoph] Contilia Heart & Vasc Ctr, Dept Cardiol & Angiol, Essen, Germany. [Prokopczuk, Janusz] PAKS Kozle, Dept Cardiol, Kozle, Poland. [Hamm, Christian] Kerckhoff Heart Ctr, Bad Nauheim, Germany. [Steg, Gabriel] Hop Bichat Claude Bernard, AP HP, Paris, France. [Heg, Dik] CTU, Inst Social & Prevent Med, Bern, Switzerland. [Heg, Dik] Clin Trials Unit, Bern, Switzerland. [Juni, Peter] St Michaels Hosp, Li Ka Shing Knowledge Inst, Appl Hlth Res Ctr, Dept Med, Toronto, ON, Canada. [Windecker, Stephan; Valgimigli, Marco] Inselspital Univ Spital Bern, Dept Cardiol, Bern, Switzerland.
URI: http://hdl.handle.net/1942/28958
DOI: 10.1136/bmjopen-2018-026053
ISI #: 000471144900252
ISSN: 2044-6055
Category: A1
Type: Journal Contribution
Appears in Collections: Research publications

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