Study to examine whether caffeine can relieve breathlessness caused by ticagrelor (TROCADERO)

Conditions: Dyspnea
MedDRA version: 17.1Level: LLTClassification code 10013963Term: DyspneaSystem Organ Class: 100000004855
Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

Registration Number: EUCTR2013-004412-22-SE

Lead Sponsor: CR Uppsala Clinical Research Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 500

Inclusion Criteria

•Age = 18 years
•Acute coronary syndrome within the last 3 months 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 and energy drinks; other foods, nutritional supplements or medications containing caffeine) for the duration of the study
•Provision of signed informed consent form

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 450
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

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 LV function
•Renal failure, 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, NSAIDs; or any drug containing theophylline or caffeine.
•Any condition that seriously increases the risk of non-compliance or loss of follow-up