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

February 5, 2016 updated by: Uppsala University

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Eskilstuna, Sweden
        • Dept of Cardiology, Mälarsjukhuset hospital
      • Falun, Sweden
        • Dept. of Cardiology, Falu hospital
      • Gothenburg, Sweden
        • Dept of Cardiology, Östra hospital
      • Gävle, Sweden
        • Dept of Cardiology, Gävle Hospital
      • Linköping, Sweden
        • Dept. of Cardiology, Linköping University Hospital
      • Lund, Sweden
        • Dept of Cardiology, Skåne University Hospital
      • Stockholm, Sweden
        • Dept. of Cardiology, Danderyd hospital
      • Umeå, Sweden
        • Dept of Cardiology, Umeå University Hospital
      • Uppsala, Sweden, SE-75185
        • Dept of Cardiology, Uppsala University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Collaborators

AstraZeneca

Investigators

  • Principal Investigator: Stefan K James, MD, PhD, Uppsala University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

December 4, 2014

First Submitted That Met QC Criteria

December 5, 2014

First Posted (Estimate)

December 8, 2014

Study Record Updates

Last Update Posted (Estimate)

February 8, 2016

Last Update Submitted That Met QC Criteria

February 5, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U-2013-007
  • 2013-004412-22 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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