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Trial record 29 of 1177 for:    adenosine

Ticagrelor and Adenosine

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ClinicalTrials.gov Identifier: NCT01996735
Recruitment Status : Completed
First Posted : November 27, 2013
Last Update Posted : January 10, 2014
Sponsor:
Information provided by (Responsible Party):
Radboud University

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Ticagrelor 180 mg single dose Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Ticagrelor on the Adenosine System
Study Start Date : April 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ticagrelor 180 mg single dose
Ticagrelor 180 mg single dose
Drug: Ticagrelor 180 mg single dose
Placebo Comparator: Placebo
Placebo single dose
Drug: Placebo



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01996735


Locations
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Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Investigators
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Principal Investigator: N. Riksen, MD, PhD Radboud University
Principal Investigator: G. Rongen, MD, PhD Radboud University
Principal Investigator: M. Gomes, MD, PhD Dept Cardiology, Canisius Wilhelmina Hospital Nijmegen
Principal Investigator: S. El Messaoudi, MD Radboud University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01996735     History of Changes
Other Study ID Numbers: NL43379.091.13
First Posted: November 27, 2013    Key Record Dates
Last Update Posted: January 10, 2014
Last Verified: February 2013
Keywords provided by Radboud University:
Endothelial function
Adenosine receptor stimulation
Additional relevant MeSH terms:
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Adenosine
Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists