Trial of Caffeine to Alleviate Dyspnea Related to Ticagrelor

Dyspnea Clinical Trial

— TROCADERO  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02311088
• Other study ID #: U-2013-007
• Secondary ID: 2013-004412-22
• Status: Terminated
• Phase: Phase 2
• First received: December 4, 2014
• Last updated: February 5, 2016
• Start date: December 2014

Study information

• Verified date: February 2016
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspnea

Intervention

Drug:
• Caffeine

• Placebo

Locations

Country	Name	City	State
Sweden	Dept of Cardiology, Mälarsjukhuset hospital	Eskilstuna
Sweden	Dept. of Cardiology, Falu hospital	Falun
Sweden	Dept of Cardiology, Gävle Hospital	Gävle
Sweden	Dept of Cardiology, Östra hospital	Gothenburg
Sweden	Dept. of Cardiology, Linköping University Hospital	Linköping
Sweden	Dept of Cardiology, Skåne University Hospital	Lund
Sweden	Dept. of Cardiology, Danderyd hospital	Stockholm
Sweden	Dept of Cardiology, Umeå University Hospital	Umeå
Sweden	Dept of Cardiology, Uppsala University Hospital	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University	AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog scale area under the curve (VAS-AUC) for dyspnea		7-10 days	No
Secondary	High on-treatment platelet reactivity by VerifyNow		7-10 days	Yes
Secondary	Change in dyspnea by 7-point Likert scale		7-10 days	No