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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02311088
Recruitment Status : Terminated (Too low enrolment rate)
First Posted : December 8, 2014
Last Update Posted : February 8, 2016
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Uppsala University

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.

Condition or disease Intervention/treatment Phase
Dyspnea Drug: Caffeine Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Trial of Caffeine to Alleviate Dyspnea Related to Ticagrelor - A Double-blinded, Placebo-controlled, Randomized, Multicenter, Development Phase II Study
Study Start Date : December 2014
Actual Primary Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Caffeine
Caffeine capsules. 200 mg twice daily orally for 7-10 days.
Drug: Caffeine
Placebo Comparator: Placebo
Matching placebo capsules twice daily orally for 7-10 days.
Drug: Placebo



Primary Outcome Measures :
  1. Visual analog scale area under the curve (VAS-AUC) for dyspnea [ Time Frame: 7-10 days ]

Secondary Outcome Measures :
  1. High on-treatment platelet reactivity by VerifyNow [ Time Frame: 7-10 days ]
  2. Change in dyspnea by 7-point Likert scale [ Time Frame: 7-10 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02311088


Locations
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Sweden
Dept of Cardiology, Mälarsjukhuset hospital
Eskilstuna, Sweden
Dept. of Cardiology, Falu hospital
Falun, Sweden
Dept of Cardiology, Östra hospital
Gothenburg, Sweden
Dept of Cardiology, Gävle Hospital
Gävle, 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, Sweden, SE-75185
Sponsors and Collaborators
Uppsala University
AstraZeneca
Investigators
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Principal Investigator: Stefan K James, MD, PhD Uppsala University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT02311088    
Other Study ID Numbers: U-2013-007
2013-004412-22 ( EudraCT Number )
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: February 8, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Dyspnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents