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Trial of Caffeine to Alleviate Dyspnea Related to Ticagrelor (TROCADERO)

Primary Purpose

Dyspnea

Status
Terminated
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Caffeine
Placebo
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyspnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years
  • Recent acute coronary syndrome with ongoing ticagrelor treatment
  • Stabilized clinical condition with no plans of additional revascularization
  • Dyspnea with onset after start of ticagrelor treatment
  • Willingness to abstain from caffeine intake (e.g. coffee, tea, cola-type beverages; other foods, nutritional supplements or medications containing caffeine) for the duration of the study
  • Provision of signed informed consent form

Exclusion Criteria:

  • Chronic obstructive pulmonary disease, asthma or other known pulmonary disease requiring daily medical therapy
  • Obstructive sleep apnea syndrome requiring therapy
  • Ongoing signs and symptoms of heart failure*, or evidence of moderately to severely reduced left ventricular (LV) function
  • Renal failure, glomerular filtration rate (GFR) <30 or on dialysis
  • Pregnancy or lactation
  • Known allergy to ticagrelor, or caffeine, or known intolerance of caffeine
  • Ongoing treatment with any of the following: quinolone antibiotics, fluvoxamine, phenylpropanolamine, carbamazepine, clozapine, lithium, non-steroidal anti-inflammatory drugs (NSAIDs); or any drug containing theophylline or caffeine.
  • Any condition that seriously increases the risk of non-compliance or loss of follow-up

Sites / Locations

  • Dept of Cardiology, Mälarsjukhuset hospital
  • Dept. of Cardiology, Falu hospital
  • Dept of Cardiology, Östra hospital
  • Dept of Cardiology, Gävle Hospital
  • Dept. of Cardiology, Linköping University Hospital
  • Dept of Cardiology, Skåne University Hospital
  • Dept. of Cardiology, Danderyd hospital
  • Dept of Cardiology, Umeå University Hospital
  • Dept of Cardiology, Uppsala University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Caffeine

Placebo

Arm Description

Caffeine capsules. 200 mg twice daily orally for 7-10 days.

Matching placebo capsules twice daily orally for 7-10 days.

Outcomes

Primary Outcome Measures

Visual analog scale area under the curve (VAS-AUC) for dyspnea

Secondary Outcome Measures

High on-treatment platelet reactivity by VerifyNow
Change in dyspnea by 7-point Likert scale

Full Information

First Posted
December 4, 2014
Last Updated
February 5, 2016
Sponsor
Uppsala University
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT02311088
Brief Title
Trial of Caffeine to Alleviate Dyspnea Related to Ticagrelor
Acronym
TROCADERO
Official Title
Trial of Caffeine to Alleviate Dyspnea Related to Ticagrelor - A Double-blinded, Placebo-controlled, Randomized, Multicenter, Development Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Terminated
Why Stopped
Too low enrolment rate
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University
Collaborators
AstraZeneca

4. Oversight

5. Study Description

Brief Summary
Ticagrelor treatment is associated with increased rates of dyspnea, where previous studies have implied a possible role of adenosine. The purpose of this study is to determine if the caffeine-antagonist is effective in reducing dyspnea related to ticagrelor.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Caffeine
Arm Type
Experimental
Arm Description
Caffeine capsules. 200 mg twice daily orally for 7-10 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo capsules twice daily orally for 7-10 days.
Intervention Type
Drug
Intervention Name(s)
Caffeine
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Visual analog scale area under the curve (VAS-AUC) for dyspnea
Time Frame
7-10 days
Secondary Outcome Measure Information:
Title
High on-treatment platelet reactivity by VerifyNow
Time Frame
7-10 days
Title
Change in dyspnea by 7-point Likert scale
Time Frame
7-10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Recent acute coronary syndrome with ongoing ticagrelor treatment Stabilized clinical condition with no plans of additional revascularization Dyspnea with onset after start of ticagrelor treatment Willingness to abstain from caffeine intake (e.g. coffee, tea, cola-type beverages; other foods, nutritional supplements or medications containing caffeine) for the duration of the study Provision of signed informed consent form Exclusion Criteria: Chronic obstructive pulmonary disease, asthma or other known pulmonary disease requiring daily medical therapy Obstructive sleep apnea syndrome requiring therapy Ongoing signs and symptoms of heart failure*, or evidence of moderately to severely reduced left ventricular (LV) function Renal failure, glomerular filtration rate (GFR) <30 or on dialysis Pregnancy or lactation Known allergy to ticagrelor, or caffeine, or known intolerance of caffeine Ongoing treatment with any of the following: quinolone antibiotics, fluvoxamine, phenylpropanolamine, carbamazepine, clozapine, lithium, non-steroidal anti-inflammatory drugs (NSAIDs); or any drug containing theophylline or caffeine. Any condition that seriously increases the risk of non-compliance or loss of follow-up
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan K James, MD, PhD
Organizational Affiliation
Uppsala University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept of Cardiology, Mälarsjukhuset hospital
City
Eskilstuna
Country
Sweden
Facility Name
Dept. of Cardiology, Falu hospital
City
Falun
Country
Sweden
Facility Name
Dept of Cardiology, Östra hospital
City
Gothenburg
Country
Sweden
Facility Name
Dept of Cardiology, Gävle Hospital
City
Gävle
Country
Sweden
Facility Name
Dept. of Cardiology, Linköping University Hospital
City
Linköping
Country
Sweden
Facility Name
Dept of Cardiology, Skåne University Hospital
City
Lund
Country
Sweden
Facility Name
Dept. of Cardiology, Danderyd hospital
City
Stockholm
Country
Sweden
Facility Name
Dept of Cardiology, Umeå University Hospital
City
Umeå
Country
Sweden
Facility Name
Dept of Cardiology, Uppsala University Hospital
City
Uppsala
ZIP/Postal Code
SE-75185
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
29898843
Citation
Lindholm D, James S, Andersson J, Braun OO, Heller S, Henriksson P, Lauermann J, Ohagen P, Varenhorst C. Caffeine and incidence of dyspnea in patients treated with ticagrelor. Am Heart J. 2018 Jun;200:141-143. doi: 10.1016/j.ahj.2018.02.011. Epub 2018 Feb 16. No abstract available.
Results Reference
derived

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Trial of Caffeine to Alleviate Dyspnea Related to Ticagrelor

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