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). [Protocol]

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, Paweł; Bolognese, Leonardo; Tumscitz, Carlo; Bryniarski, Krzysztof; Aminian, Adel; ... (2019). 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). [Protocol]. BMJ open, 9(3), e026053. BMJ Publishing Group 10.1136/bmjopen-2018-026053

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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. TRIAL REGISTRATION NUMBER NCT01813435.

Item Type:

Journal Article (Further Contribution)

Division/Institute:

04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology
04 Faculty of Medicine > Pre-clinic Human Medicine > Institute of Social and Preventive Medicine
04 Faculty of Medicine > Pre-clinic Human Medicine > CTU Bern
04 Faculty of Medicine > Pre-clinic Human Medicine > BioMedical Research (DBMR) > DBMR Forschung Mu35 > Forschungsgruppe Kardiologie
04 Faculty of Medicine > Pre-clinic Human Medicine > BioMedical Research (DBMR) > DBMR Forschung Mu35 > Forschungsgruppe Kardiologie

UniBE Contributor:

Heg, Dierik Hans; Windecker, Stephan and Valgimigli, Marco

Subjects:

600 Technology > 610 Medicine & health
300 Social sciences, sociology & anthropology > 360 Social problems & social services

ISSN:

2044-6055

Publisher:

BMJ Publishing Group

Language:

English

Submitter:

Andrea Flükiger-Flückiger

Date Deposited:

13 Mar 2019 13:24

Last Modified:

23 Oct 2019 00:38

Publisher DOI:

10.1136/bmjopen-2018-026053

PubMed ID:

30852547

Uncontrolled Keywords:

coronary heart disease coronary intervention ischaemic heart disease myocardial infarction

BORIS DOI:

10.7892/boris.127856

URI:

https://boris.unibe.ch/id/eprint/127856

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