NCT01996735

Brief Summary

Preclinical studies have shown that the P2Y12 receptor antagonist ticagrelor can increase the extracellular concentration of the endogenous nucleoside adenosine by inhibiting the cellular uptake of adenosine via the equilibrative nucleoside transporter (ENT). This mechanism can contribute to the beneficial effects and to the side effects (dyspnea) of ticagrelor in patients with an acute myocardial infarction. In the current research proposal, we aim to investigate whether ticagrelor increases adenosine receptor stimulation in humans in vivo by ENT inhibition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for phase_4 healthy

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2013

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
26 days until next milestone

First Posted

Study publicly available on registry

November 27, 2013

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 10, 2014

Status Verified

February 1, 2013

Enrollment Period

7 months

First QC Date

April 26, 2013

Last Update Submit

January 9, 2014

Conditions

Healthy

Keywords

Endothelial functionAdenosine receptor stimulation

Outcome Measures

Primary Outcomes (2)

  • Forearm blood flow response

    Forearm blood flow response to the intrabrachial administration of incremental dosages of adenosine, after treatment with ticagrelor compared to placebo. The forearm blood flow will be measured by plethysmography.

    2 hours after intake of ticagrelor/placebo

  • Forearm blood flow response

    Directly after 2 and 5 minutes of forearm ischemia.The forearm blood flow will be measured by plethysmography.

    Directly after 2 and 5 minutes of forearm ischemia

Secondary Outcomes (2)

  • Forearm blood flow respons

    Directly after administration of dipyridamole

  • ex-vivo adenosine uptake in isolated erythrocytes

    2 hours after intake of studymedication

Study Arms (2)

Ticagrelor 180 mg single dose

ACTIVE COMPARATOR

Ticagrelor 180 mg single dose

Drug: Ticagrelor 180 mg single dose

Placebo

PLACEBO COMPARATOR

Placebo single dose

Drug: Placebo

Interventions

Ticagrelor 180 mg single doseDRUG
Ticagrelor 180 mg single dose
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male sex
  • Age 18-40 years
  • Healthy
  • Written informed consent

You may not qualify if:

  • Smoking
  • Hypertension (Blood pressure \>140 mmHg and/or \>90 mmHg - SBP/DBP-)
  • Diabetes Mellitus (fasting glucose \> 7.0 mmol/L or random \> 11.0 mmol/L)
  • History of any cardiovascular disease
  • History of chronic obstructive pulmonary disease (COPD) or asthma
  • Bleeding tendency
  • Concomitant use of medication
  • Renal dysfunction (MDRD \< 60 ml/min)
  • Liver enzyme abnormalities (ALAT \> twice upper limit of normality)
  • Thrombocytopenia (\<150\*109/ml)
  • Second/third degree AV-block on electrocardiography

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

Related Publications (1)

  • van den Berg TN, El Messaoudi S, Rongen GA, van den Broek PH, Bilos A, Donders AR, Gomes ME, Riksen NP. Ticagrelor Does Not Inhibit Adenosine Transport at Relevant Concentrations: A Randomized Cross-Over Study in Healthy Subjects In Vivo. PLoS One. 2015 Oct 28;10(10):e0137560. doi: 10.1371/journal.pone.0137560. eCollection 2015.

    PMID: 26509673DERIVED

MeSH Terms

Interventions

Ticagrelor

Intervention Hierarchy (Ancestors)

AdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • N. Riksen, MD, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

  • G. Rongen, MD, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

  • M. Gomes, MD, PhD

    Dept Cardiology, Canisius Wilhelmina Hospital Nijmegen

    PRINCIPAL INVESTIGATOR

  • S. El Messaoudi, MD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2013

First Posted

November 27, 2013

Study Start

April 1, 2013

Primary Completion

November 1, 2013

Study Completion

December 1, 2013

Last Updated

January 10, 2014

Record last verified: 2013-02

Locations

NL(1)