TY - JOUR
T1 - 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
T2 - The GLOBAL LEADERS Adjudication Sub-StudY (GLASSY)
AU - Leonardi, Sergio
AU - Franzone, Anna
AU - Piccolo, Raffaele
AU - McFadden, Eugene
AU - Vranckx, Pascal
AU - Serruys, Patrick
AU - Benit, Edouard
AU - Liebetrau, Christoph
AU - Janssens, Luc
AU - Ferrario, Maurizio
AU - Zurakowski, Aleksander
AU - Van Geuns, Robert Jan
AU - Dominici, Marcello
AU - Huber, Kurt
AU - Slagboom, Ton
AU - Buszman, Pawel
AU - Bolognese, Leonardo
AU - Tumscitz, Carlo
AU - Bryniarski, Krzysztof
AU - Aminian, Adel
AU - Vrolix, Mathias
AU - Petrov, Ivo
AU - Garg, Scot
AU - Naber, Christoph
AU - Prokopczuk, Janusz
AU - Hamm, Christian
AU - Steg, Gabriel
AU - Heg, Dik
AU - Juni, Peter
AU - Windecker, Stephan
AU - Valgimigli, Marco
PY - 2019/3/1
Y1 - 2019/3/1
N2 - 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.
AB - 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.
KW - coronary heart disease
KW - coronary intervention
KW - ischaemic heart disease
KW - myocardial infarction
UR - http://www.scopus.com/inward/record.url?scp=85062712920&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85062712920&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2018-026053
DO - 10.1136/bmjopen-2018-026053
M3 - Article
C2 - 30852547
AN - SCOPUS:85062712920
VL - 9
JO - BMJ Open
JF - BMJ Open
SN - 2044-6055
IS - 3
M1 - e026053
ER -