Clinical trial NCT02311088: Trial of Caffeine to Alleviate Dyspnea Related to Ticagrelor
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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Dyspnea
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2014-12-08
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Visual analog scale area under the curve (VAS-AUC) for dyspnea
timeFrame: 7-10 days
Secondary outcomes:
measure: High on-treatment platelet reactivity by VerifyNow
timeFrame: 7-10 days
measure: Change in dyspnea by 7-point Likert scale
timeFrame: 7-10 days
Other outcomes:
Locations:
city: Eskilstuna
country: Sweden
facility: Dept of Cardiology, Mälarsjukhuset hospital
city: Falun
country: Sweden
facility: Dept. of Cardiology, Falu hospital
city: Gothenburg
country: Sweden
facility: Dept of Cardiology, Östra hospital
city: Gävle
country: Sweden
facility: Dept of Cardiology, Gävle Hospital
city: Linköping
country: Sweden
facility: Dept. of Cardiology, Linköping University Hospital
city: Lund
country: Sweden
facility: Dept of Cardiology, Skåne University Hospital
city: Stockholm
country: Sweden
facility: Dept. of Cardiology, Danderyd hospital
city: Umeå
country: Sweden
facility: Dept of Cardiology, Umeå University Hospital
city: Uppsala
country: Sweden
facility: Dept of Cardiology, Uppsala University Hospital
Study officials:
affiliation: Uppsala University
name: Stefan K James, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.