Trial of Caffeine to Alleviate Dyspnea Related to Ticagrelor

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Dyspnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Caffeine

Caffeine capsules. 200 mg twice daily orally for 7-10 days.

Group Type EXPERIMENTAL

Caffeine

Intervention Type DRUG

Placebo

Matching placebo capsules twice daily orally for 7-10 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Caffeine

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No