Status:
TERMINATED
Trial of Caffeine to Alleviate Dyspnea Related to Ticagrelor
Lead Sponsor:
Uppsala University
Collaborating Sponsors:
AstraZeneca
Conditions:
Dyspnea
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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-antagoni...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT02311088
Start Date
December 1 2014
Last Update
February 8 2016
Active Locations (9)
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1
Dept of Cardiology, Mälarsjukhuset hospital
Eskilstuna, Sweden
2
Dept. of Cardiology, Falu hospital
Falun, Sweden
3
Dept of Cardiology, Gävle Hospital
Gävle, Sweden
4
Dept of Cardiology, Östra hospital
Gothenburg, Sweden