title: Long-term ticagrelor monotherapy versus standard dual antiplatelet therapy followed by aspirin monotherapy in patients undergoing biolimus-eluting stent implantation: rationale and design of the GLOBAL LEADERS trial.
abstract: OBJECTIVE
  The GLOBAL LEADERS trial is a superiority study in patients undergoing percutaneous coronary intervention, with a uniform use of Biolimus A9-eluting stents (BES) and bivalirudin. GLOBAL LEADERS was designed to assess whether a 24-month antithrombotic regimen with ticagrelor and one month of acetylsalicylic acid (ASA), compared to conventional dual antiplatelet therapy (DAPT), improves outcomes.
  
  
  RESULTS
  Patients (n >16,000) are randomised (1:1 ratio) to ticagrelor 90 mg twice daily for 24 months plus ASA ≤100 mg for one month versus DAPT with either ticagrelor (acute coronary syndrome) or clopidogrel (stable coronary artery disease) for 12 months plus ASA ≤100 mg for 24 months. The primary outcome is a composite of all-cause mortality or non-fatal, new Q-wave myocardial infarction at 24 months. The key safety endpoint is investigator-reported class 3 or 5 bleeding according to the Bleeding Academic Research Consortium (BARC) definitions. Sensitivity analysis will be carried out to explore potential differences in outcome across geographic regions and according to specific angiographic and clinical risk estimates.
  
  
  CONCLUSIONS
  The GLOBAL LEADERS trial aims to assess the role of ticagrelor as a single antiplatelet agent after a short course of DAPT for the long-term prevention of cardiac adverse events, across a wide spectrum of patients, following BES implantation.
authors.affiliation: Hartcentrum Hasselt, Hasselt, Belgium.
authors.forename: Pascal
authors.initials: P
authors.lastname: Vranckx
authors.forename: Marco
authors.initials: M
authors.lastname: Valgimigli
authors.forename: Stephan
authors.initials: S
authors.lastname: Windecker
authors.forename: Philippe Gabriel
authors.initials: PG
authors.lastname: Steg
authors.forename: Christian
authors.initials: C
authors.lastname: Hamm
authors.forename: Peter
authors.initials: P
authors.lastname: Jüni
authors.forename: Hector M
authors.initials: HM
authors.lastname: Garcia-Garcia
authors.forename: Gerrit Anne
authors.initials: GA
authors.lastname: van Es
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
mesh_terms: D054058:Acute Coronary Syndrome / Q000628:therapy; D000241:Adenosine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001241:Aspirin / Q000627:therapeutic use*; D004338:Drug Combinations; D054855:Drug-Eluting Stents; D005260:Female; D006470:Hemorrhage / Q000150:complications; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000628:therapy; D062645:Percutaneous Coronary Intervention / Q000379:methods; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D058921:Purinergic P2Y Receptor Antagonists / Q000627:therapeutic use*; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000077486:Ticagrelor; D013995:Time; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D004338:Drug Combinations; D010975:Platelet Aggregation Inhibitors; D058921:Purinergic P2Y Receptor Antagonists; D000077486:Ticagrelor; D000241:Adenosine; D001241:Aspirin; C518022:umirolimus; D020123:Sirolimus