GLOBAL LEADERS Adjudication Sub-Study (GLASSY)
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|ClinicalTrials.gov Identifier: NCT03231059|
Recruitment Status : Completed
First Posted : July 27, 2017
Last Update Posted : August 3, 2020
|Condition or disease|
|Coronary Artery Disease Platelet-aggregation Inhibitors|
|Study Type :||Observational|
|Actual Enrollment :||7365 participants|
|Official Title:||GLOBAL LEADERS Adjudication Sub-Study|
|Actual Study Start Date :||June 1, 2017|
|Actual Primary Completion Date :||December 30, 2019|
|Actual Study Completion Date :||May 30, 2020|
Experimental treatment strategy
All patients in the treatment group received acetylsalicylic acid (ASA) and ticagrelor for 1 month followed by 23 months of ticagrelor monotherapy
Reference treatment strategy
Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and ticagrelor for 12 months followed by 12 months of ASA monotherapy.
Stable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy.
- Composite of death, stroke, cardiac and bleeding events [ Time Frame: 24 months ]
Death, any non-fatal MI, any non-fatal stroke (i.e. including both ischemic and haemorrhagic) or urgent target vessel revascularization (TVR) (co-primary efficacy endpoint) Bleeding 3 or 5 according to Bleeding Academic Research Consortium (BARC) definition (co-primary safety endpoint).
Primary outcome will be defined as the occurrence of the sum of listed events
- Death [ Time Frame: 24 months or at earlier time point ]Any death
- Non-fatal MI [ Time Frame: 24 months or at earlier time point ]Any non-fatal MI
- Non-fatal stroke [ Time Frame: 24 months or at earlier time point ]Any non-fatal stroke (i.e. including both ischemic and haemorrhagic)
- Rates of urgent revascularization of the target vessel (Urgent TVR) [ Time Frame: 24 months or at earlier time point ]One or more episodes of rest pain, presumed to be ischemic in origin which results in either urgent percutaneous coronary intervention or urgent coronary artery by pass graft. To be considered urgent, the repeat revascularization will be initiated within 24 hours of the last episode of ischemia and not be identified as planned or staged.
- Definite, probable or possible Stent thrombosis [ Time Frame: 24 months or at earlier time point ]Definite, probable or possible Stent thrombosis according to Academic Research Consortium (ARC) classification
- Bleeding events [ Time Frame: 24 months or at earlier time point ]Bleeding events according to Bleeding Academic Research Consortium (BARC), Thrombolysis In Myocardial Infarction (TIMI) and Global Use of Strategies To Open coronary arteries (GUSTO) classifications
- Differences between the rates of outcomes reported by the investigators and the rates of outcomes as adjudicated by an independent clinical event committee [ Time Frame: 24 months or at earlier time point ]Concordance between IR- and CEC- endpoints
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03231059
|Study Chair:||Stephan Windecker, MD||Inselspital Bern University Hospital|
|Principal Investigator:||Marco Valgimigli, MD||Inselspital Bern University Hospital|