DyspneaPhase 2TROCADERONCT02311088
Trial of Caffeine to Alleviate Dyspnea Related to Ticagrelor
A Phase 2 study testing Caffeine in people with Dyspnea, run by Uppsala University at 9 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea
- What is being tested?
- Caffeine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 9 sitesSweden
- Study dates
- Dec 2014to Dec 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Sweden9 sites
Dept of Cardiology, Mälarsjukhuset hospital
Eskilstuna
Dept. of Cardiology, Falu hospital
Falun
Dept of Cardiology, Gävle Hospital
Gävle
Dept of Cardiology, Östra hospital
Gothenburg
Dept. of Cardiology, Linköping University Hospital
Linköping
Dept of Cardiology, Skåne University Hospital
Lund
Dept. of Cardiology, Danderyd hospital
Stockholm
Dept of Cardiology, Umeå University Hospital
Umeå
Dept of Cardiology, Uppsala University Hospital
Uppsala, SE-75185
About this study
Official title: 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaffeineDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Caffeine | Experimental | Caffeine capsules. 200 mg twice daily orally for 7-10 days. Receives: Drug: Caffeine |
| Placebo | Placebo comparator | Matching placebo capsules twice daily orally for 7-10 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale area under the curve (VAS-AUC) for dyspnea
Measured: 7-10 days
Secondary outcomes (2)
High on-treatment platelet reactivity by VerifyNow
Measured: 7-10 days
Change in dyspnea by 7-point Likert scale
Measured: 7-10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2015
Why it stopped: Too low enrolment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyspneaStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Stefan K James, MD, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02311088
- Sponsor's protocol ID
- U-2013-007
- Other IDs
- 2013-004412-22
- Acronym
- TROCADERO
- Status last verified
- Feb 2016
- First submitted
- 4 Dec 2014
- Last updated
- 8 Feb 2016
- Results posted
- No
Publications
Lindholm D, James S, Andersson J, Braun OO, Heller S, Henriksson P, Lauermann J, Ohagen P, Varenhorst C. Caffeine and incidence of dyspnea in patients treated with ticagrelor. Am Heart J. 2018 Jun;200:141-143. doi: 10.1016/j.ahj.2018.02.011. Epub 2018 Feb 16. No abstract available.
PubMed 29898843
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Caffeine to Alleviate Dyspnea Related to Ticagrelor - A Double-blinded, Placebo-controlled, Randomized, Multicenter, Development Phase II Study
- ClinicalTrials.gov ID
- NCT02311088
- Acronym / sponsor ID
- TROCADERO / U-2013-007
- Conditions
- Dyspnea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Too low enrolment rate
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (actual)
- First posted
- 8 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caffeine | Experimental | Drug: CaffeineCaffeine capsules. 200 mg twice daily orally for 7-10 days. |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo capsules twice daily orally for 7-10 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caffeine | Drug | Caffeine |
| Placebo | Drug | Placebo |
Primary outcome
Visual analog scale area under the curve (VAS-AUC) for dyspnea
Time frame: 7-10 days
2 secondary outcomes
High on-treatment platelet reactivity by VerifyNow
Time frame: 7-10 days
Change in dyspnea by 7-point Likert scale
Time frame: 7-10 days
Results and safety
The study was stopped early (reason given: Too low enrolment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
- Derived from this study: PubMed 29898843Lindholm D, James S, Andersson J, Braun OO, Heller S, Henriksson P, Lauermann J, Ohagen P, Varenhorst C. Caffeine and incidence of dyspnea in patients treated with ticagrelor. Am Heart J. 2018 Jun;200:141-143. doi: 10.1016/j.ahj.2018.02.011. Epub 2018 Feb 16. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan K James, MD, PhD principal investigator
Uppsala University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Caffeine in people with Dyspnea, run by Uppsala University at 9 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Too low enrolment rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale area under the curve (VAS-AUC) for dyspnea (time frame: 7-10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02311088, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2016.