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Effect of Ticagrelor vs. Dipyridamole on Adenosine Uptake

Sponsor
Vanderbilt University (Other)
Overall Status
Completed
CT.gov ID
NCT01690884
Collaborator
(none)
28
Enrollment
1
Location
3
Arms
53
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators are trying to determine if a single dose of Ticagrelor will increase delivery of intraarterially-infused adenosine into the forearm interstitium, consistent with adenosine reuptake blockade.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

The investigators will compare adenosine interstitial levels using a parallel design study with three groups of subjects. Forearm interstitial adenosine levels will be measured at baseline and after intrabrachial infusion of adenosine at two doses. Subjects will then randomly receive Ticagrelor 180 mg, Dipyridamole 200 mg, or placebo. Two hours later the investigators will repeat the dialysate collections at baseline and after adenosine infusions.

Study Design

Study Type:
Interventional
Actual Enrollment :
28 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
Ticagrelor and Adenosine Uptake. Phase II Study Comparing the Effects of Ticagrelor vs Dipyridamole on Adenosine Uptake
Study Start Date :
Aug 1, 2012
Actual Primary Completion Date :
Jan 1, 2017
Actual Study Completion Date :
Jan 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

To determine if there is an increase in adenosine interstitial levels in the forearm.

Drug: Adenosine
Adenosine will be infused into the brachial artery at 0.125 mg/min for 15 minutes and then at 0.5 mg/min for an additional 15 minutes,
Other Names:
  • Adenocard

    		•
    Active Comparator: Dipyridamole

    To determine if there is an increase in adenosine interstitial levels in the forearm.

    Drug: Adenosine
    Adenosine will be infused into the brachial artery at 0.125 mg/min for 15 minutes and then at 0.5 mg/min for an additional 15 minutes,
    Other Names:
  • Adenocard

    		•
    Experimental: Ticagrelor

    To determine if there is an increase in adenosine interstitial levels in the forearm.

    Drug: Adenosine
    Adenosine will be infused into the brachial artery at 0.125 mg/min for 15 minutes and then at 0.5 mg/min for an additional 15 minutes,
    Other Names:
  • Adenocard

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Interstitial levels of adenosine [After each dose of intrabrachial adenosine]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Subjects will be healthy volunteers, without significant pulmonary, cardiovascular gastrointestinal, hematological or renal diseases

    2. Not taking any regular medications

    3. Able to provide signed consent prior to study participation.

    Exclusion Criteria:

    1. History of asthma

    2. Pregnancy

    3. Exposure to an investigational drug in the last 2 months.

    4. Known hypersensitivity to study medications

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Autonomic Dysfunction Center Nashville Tennessee United States 37232

    Sponsors and Collaborators

    • Vanderbilt University

    Investigators

    • Principal Investigator: Italo Biaggioni, MD, Vanderbilt University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Italo Biaggioni, Professor of Medicine and Pharmacology, Vanderbilt University
    ClinicalTrials.gov Identifier:
    NCT01690884
    Other Study ID Numbers:
    • 120477
    First Posted:
    Sep 24, 2012
    Last Update Posted:
    Feb 28, 2018
    Last Verified:
    Feb 1, 2018
    Keywords provided by Italo Biaggioni, Professor of Medicine and Pharmacology, Vanderbilt University
    Adenosine
    Ticagrelor
    Microdialysis
    Additional relevant MeSH terms:
    Coronary Artery Disease
    Adenosine

    Study Results

    No Results Posted as of Feb 28, 2018