Trial of Caffeine to Alleviate Dyspnea Related to Ticagrelor

Trial of Caffeine to Alleviate Dyspnea Related to Ticagrelor - A Double-blinded, Placebo-controlled, Randomized, Multicenter, Development Phase II Study

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02311088

Acronym

TROCADERO

Enrollment

Registered

2014-12-08

Start date

2014-12-31

Completion date

Unknown

Last updated

2016-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyspnea

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.

Interventions

DRUGCaffeine

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Visual analog scale area under the curve (VAS-AUC) for dyspnea	7-10 days

Secondary

Measure	Time frame
High on-treatment platelet reactivity by VerifyNow	7-10 days
Change in dyspnea by 7-point Likert scale	7-10 days

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026