CClinicalTrials.gg
TerminatedNCT02311088TROCADEROUpdated Feb 8, 2016

Trial of Caffeine to Alleviate Dyspnea Related to Ticagrelor

A Phase 2 interventional study of Caffeine and Placebo in Dyspnea, sponsored by Uppsala University. Terminated at 9 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-08.

Sponsored by Uppsala University · Phase 2, Interventional, and Treatment

Why this study was terminated
Too low enrolment rate
Phase
Phase 2
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Dyspnea

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In context

Dyspnea

656 studies on the registry are indexed under Dyspnea; 153 are open to participants now.

This study's enrollment of 26 is below the median of 48 across 430 interventional studies indexed under Dyspnea.

Browse Dyspnea studies →

Lead sponsor

Uppsala University is the lead sponsor of 381 studies on the registry; 84 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    Caffeine

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

    Drug: Caffeine

  • Placebo comparator
    Placebo

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

    Drug: Placebo

Interventions

  • DrugCaffeine
  • DrugPlacebo
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What researchers measure

Primary outcomes

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

    Time frame: 7-10 days

Secondary outcomes

  1. High on-treatment platelet reactivity by VerifyNow

    Time frame: 7-10 days

  2. Change in dyspnea by 7-point Likert scale

    Time frame: 7-10 days

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Study locations

9 sites
  • Dept of Cardiology, Mälarsjukhuset hospital
    Eskilstuna, Sweden
  • Dept. of Cardiology, Falu hospital
    Falun, Sweden
  • Dept of Cardiology, Östra hospital
    Gothenburg, Sweden
  • Dept of Cardiology, Gävle Hospital
    Gävle, Sweden
  • Dept. of Cardiology, Linköping University Hospital
    Linköping, Sweden
  • Dept of Cardiology, Skåne University Hospital
    Lund, Sweden
  • Dept. of Cardiology, Danderyd hospital
    Stockholm, Sweden
  • Dept of Cardiology, Umeå University Hospital
    Umeå, Sweden
  • Dept of Cardiology, Uppsala University Hospital
    Uppsala, SE-75185, Sweden
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References and documents

Publications

  • 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. PubMed 29898843 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02311088
Lead sponsor
Uppsala University
Collaborators
AstraZeneca
Responsible party
Sponsor
First posted
Dec 8, 2014
Start date
Dec 2014
Primary completion
Dec 2015
Last update
Feb 8, 2016

Study contacts

Stefan K James, MD, PhD
principal investigator · Uppsala University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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