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Trial record 29 of 1239 for:    adenosine

Ticagrelor and Adenosine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE April 26, 2013
First Posted Date  ICMJE November 27, 2013
Last Update Posted Date January 10, 2014
Study Start Date  ICMJE April 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2013)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2013)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ticagrelor and Adenosine
Official Title  ICMJE The Effect of Ticagrelor on the Adenosine System
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Ticagrelor 180 mg single dose
  • Drug: Placebo
Study Arms  ICMJE
  • Active Comparator: Ticagrelor 180 mg single dose
    Ticagrelor 180 mg single dose
    Intervention: Drug: Ticagrelor 180 mg single dose
  • Placebo Comparator: Placebo
    Placebo single dose
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 21, 2013)
14
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01996735
Other Study ID Numbers  ICMJE NL43379.091.13
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Radboud University
Study Sponsor  ICMJE Radboud University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Radboud University
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP