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.

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.

• Authors: Daniel Lindholm, Robert F Storey, Christina Christersson, Sigrun Halvorsen, Erik L Grove, Oscar Ö Braun, Christoph Varenhorst, Stefan K James
• Journal: American heart journal (Am Heart J) Vol. 170 Issue 3 Pg. 465-70 (Sep 2015) ISSN: 1097-6744 [Electronic] United States
• PMID: 26385029 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2015 Elsevier Inc. All rights reserved.

Chemical References

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

Topics

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