NCT02311088

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

9 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 8, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Last Updated

February 8, 2016

Status Verified

February 1, 2016

Enrollment Period

1 year

First QC Date

December 4, 2014

Last Update Submit

February 5, 2016

Conditions

Dyspnea

Outcome Measures

Primary Outcomes (1)

  • Visual analog scale area under the curve (VAS-AUC) for dyspnea

    7-10 days

Secondary Outcomes (2)

  • High on-treatment platelet reactivity by VerifyNow

    7-10 days

  • Change in dyspnea by 7-point Likert scale

    7-10 days

Study Arms (2)

Caffeine

EXPERIMENTAL

Caffeine capsules. 200 mg twice daily orally for 7-10 days.

Drug: Caffeine

Placebo

PLACEBO COMPARATOR

Matching placebo capsules twice daily orally for 7-10 days.

Drug: Placebo

Interventions

CaffeineDRUG
Caffeine
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Dept of Cardiology, Mälarsjukhuset hospital

Eskilstuna, Sweden

Location

Dept. of Cardiology, Falu hospital

Falun, Sweden

Location

Dept of Cardiology, Gävle Hospital

Gävle, Sweden

Location

Dept of Cardiology, Östra hospital

Gothenburg, Sweden

Location

Dept. of Cardiology, Linköping University Hospital

Linköping, Sweden

Location

Dept of Cardiology, Skåne University Hospital

Lund, Sweden

Location

Dept. of Cardiology, Danderyd hospital

Stockholm, Sweden

Location

Dept of Cardiology, Umeå University Hospital

Umeå, Sweden

Location

Dept of Cardiology, Uppsala University Hospital

Uppsala, SE-75185, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 29898843DERIVED

MeSH Terms

Conditions

Dyspnea

Interventions

Caffeine

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Stefan K James, MD, PhD

    Uppsala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2014

First Posted

December 8, 2014

Study Start

December 1, 2014

Primary Completion

December 1, 2015

Last Updated

February 8, 2016

Record last verified: 2016-02

Locations

SE(9)