Ticagrelor and Adenosine

NCT ID: NCT01996735

Last Updated: 2014-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ticagrelor 180 mg single dose

Ticagrelor 180 mg single dose

Group Type ACTIVE_COMPARATOR

Ticagrelor 180 mg single dose

Intervention Type DRUG

Placebo

Placebo single dose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Ticagrelor 180 mg single dose

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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N. Riksen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

G. Rongen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

M. Gomes, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dept Cardiology, Canisius Wilhelmina Hospital Nijmegen

S. El Messaoudi, MD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

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Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 26509673 (View on PubMed)

Other Identifiers

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NL43379.091.13

Identifier Type: -

Identifier Source: org_study_id

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