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NCT Number: NCT01996735

Ticagrelor and Adenosine

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.

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Key information

Conditions

Healthy

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, 6500 HB, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ticagrelor 180 mg single dose

Drug

Placebo

Drug

Primary outcomes

  1. Forearm blood flow response

    Time frame: 2 hours after intake of ticagrelor/placebo

    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. Forearm blood flow response

    Time frame: Directly after 2 and 5 minutes of forearm ischemia

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

Secondary outcomes

  1. Forearm blood flow respons

    Time frame: Directly after administration of dipyridamole

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

  2. ex-vivo adenosine uptake in isolated erythrocytes

    Time frame: 2 hours after intake of studymedication

    To study whether ticagrelor inhibits the ex-vivo adenosine uptake in isolated erythrocytes

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

The Effect of Ticagrelor on the Adenosine System

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Nov 27, 2013
Registry last updated
Jan 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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