Design and rationale of TROCADERO: A TRial Of Caffeine to Alleviate DyspnEa Related to ticagrelOr

Am Heart J. 2015 Sep;170(3):465-70. doi: 10.1016/j.ahj.2015.06.014. Epub 2015 Jun 26.

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.

Objectives: 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.

Design: 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.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acute Coronary Syndrome / diagnosis
  • Acute Coronary Syndrome / drug therapy*
  • Acute Coronary Syndrome / physiopathology
  • Adenosine / adverse effects
  • Adenosine / analogs & derivatives*
  • Adenosine / therapeutic use
  • Caffeine / administration & dosage*
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Dyspnea / chemically induced*
  • Dyspnea / diagnosis
  • Dyspnea / physiopathology
  • Electrocardiography
  • Purinergic P1 Receptor Antagonists / administration & dosage
  • Purinergic P2Y Receptor Antagonists / adverse effects
  • Ticagrelor

Substances

  • Purinergic P1 Receptor Antagonists
  • Purinergic P2Y Receptor Antagonists
  • Caffeine
  • Ticagrelor
  • Adenosine