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Ticagrelor and Adenosine

Sponsor
Radboud University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01996735
Collaborator
(none)
14
Enrollment
1
Location
2
Arms
8
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Ticagrelor 180 mg single dose
  • Drug: Placebo
 Phase 4

Study Design

Study Type:
Interventional
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 :
Apr 1, 2013
Actual Primary Completion Date :
Nov 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Forearm blood flow response [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 [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 [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 [2 hours after intake of studymedication]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Radboud University Nijmegen Medical Centre Nijmegen Gelderland Netherlands 6500 HB

Sponsors and Collaborators

  • Radboud University Medical Center

Investigators

  • Principal Investigator: 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Radboud University Medical Center
ClinicalTrials.gov Identifier:
NCT01996735
Other Study ID Numbers:
  • NL43379.091.13
First Posted:
Nov 27, 2013
Last Update Posted:
Jan 10, 2014
Last Verified:
Feb 1, 2013
Keywords provided by Radboud University Medical Center
Endothelial function
Adenosine receptor stimulation
Additional relevant MeSH terms:
Ticagrelor

Study Results

No Results Posted as of Jan 10, 2014