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

Uppsala University

Status and phase

Terminated

Phase 2

Conditions

Dyspnea

Treatments

Drug: Placebo

Drug: Caffeine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02311088

U-2013-007

2013-004412-22 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

No 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