Trial of Caffeine to Alleviate Dyspnea Related to Ticagrelor

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Uppsala University
• Collaborator: AstraZeneca
• Treatments: Caffeine; Ticagrelor

Criteria

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