title: Design and rationale of TROCADERO: A TRial Of Caffeine to Alleviate DyspnEa Related to ticagrelOr.
abstract: BACKGROUND
  Ticagrelor treatment has the side effect of increased incidence of dyspnea. Adenosine-induced dyspnea is augmented by ticagrelor and can be alleviated with the adenosine antagonist theophylline. Caffeine is a closely related xanthine derivative.
  
  
  OBJECTIVE
  The primary objective of the TROCADERO is to evaluate the effect of caffeine versus placebo on ticagrelor-associated dyspnea, measured by the visual analog scale area under the curve in patients with ongoing ticagrelor treatment after an acute coronary syndrome event.
  
  
  METHODS
  After a run-in period of 1 to 7 days of absence of caffeine intake, acute coronary syndrome patients with ticagrelor-induced dyspnea (planned inclusion 416) are randomized in a blinded fashion to either caffeine 200 mg twice daily or matching placebo with a treatment duration of 1 week. The primary efficacy end point is change in visual analog scale area under the curve for dyspnea, and the primary safety end point is occurrence of high on-treatment platelet reactivity measured by the VerifyNow P2Y12 assay.
  
  
  CONCLUSIONS
  This trial will determine if adenosine antagonism by caffeine can alleviate ticagrelor-related dyspnea, without impairing the antiplatelet effect of ticagrelor.
authors.affiliation: Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden; Uppsala Clinical Research Center, Uppsala, Sweden. Electronic address: daniel.lindholm@ucr.uu.se.
authors.forename: Daniel
authors.initials: D
authors.lastname: Lindholm
authors.affiliation: Department of Cardiovascular Science, University of Sheffield, Sheffield, UK.
authors.forename: Robert F
authors.initials: RF
authors.lastname: Storey
authors.affiliation: Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden.
authors.forename: Christina
authors.initials: C
authors.lastname: Christersson
authors.affiliation: Department of Cardiology, Oslo University Hospital Ulleval and University of Oslo, Oslo, Norway.
authors.forename: Sigrun
authors.initials: S
authors.lastname: Halvorsen
authors.affiliation: Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.
authors.forename: Erik L
authors.initials: EL
authors.lastname: Grove
authors.affiliation: Department of Cardiology, Skåne University Hospital, Lund University, Lund, Sweden.
authors.forename: Oscar Ö
authors.initials: OÖ
authors.lastname: Braun
authors.affiliation: Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden; Uppsala Clinical Research Center, Uppsala, Sweden.
authors.forename: Christoph
authors.initials: C
authors.lastname: Varenhorst
authors.affiliation: Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden; Uppsala Clinical Research Center, Uppsala, Sweden.
authors.forename: Stefan K
authors.initials: SK
authors.lastname: James
mesh_terms: D054058:Acute Coronary Syndrome / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D000241:Adenosine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D002110:Caffeine / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004417:Dyspnea / Q000139:chemically induced* / Q000175:diagnosis / Q000503:physiopathology; D004562:Electrocardiography; D058915:Purinergic P1 Receptor Antagonists / Q000008:administration & dosage; D058921:Purinergic P2Y Receptor Antagonists / Q000009:adverse effects; D000077486:Ticagrelor
chemical_list: D058915:Purinergic P1 Receptor Antagonists; D058921:Purinergic P2Y Receptor Antagonists; D002110:Caffeine; D000077486:Ticagrelor; D000241:Adenosine