Effect of Ticagrelor vs. Dipyridamole on Adenosine Uptake
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Adenosine
Sponsored by
About this trial
This is an interventional other trial for Coronary Artery Disease focused on measuring Adenosine, Ticagrelor, Microdialysis
Eligibility Criteria
Inclusion Criteria:
- Subjects will be healthy volunteers, without significant pulmonary, cardiovascular gastrointestinal, hematological or renal diseases
- Not taking any regular medications
- Able to provide signed consent prior to study participation.
Exclusion Criteria:
- History of asthma
- Pregnancy
- Exposure to an investigational drug in the last 2 months.
- Known hypersensitivity to study medications
Sites / Locations
- Autonomic Dysfunction Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Experimental
Arm Label
Placebo
Dipyridamole
Ticagrelor
Arm Description
To determine if there is an increase in adenosine interstitial levels in the forearm.
To determine if there is an increase in adenosine interstitial levels in the forearm.
To determine if there is an increase in adenosine interstitial levels in the forearm.
Outcomes
Primary Outcome Measures
Interstitial levels of adenosine
Secondary Outcome Measures
Full Information
NCT ID
NCT01690884
First Posted
August 27, 2012
Last Updated
February 27, 2018
Sponsor
Vanderbilt University
1. Study Identification
Unique Protocol Identification Number
NCT01690884
Brief Title
Effect of Ticagrelor vs. Dipyridamole on Adenosine Uptake
Official Title
Ticagrelor and Adenosine Uptake. Phase II Study Comparing the Effects of Ticagrelor vs Dipyridamole on Adenosine Uptake
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Adenosine, Ticagrelor, Microdialysis
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
To determine if there is an increase in adenosine interstitial levels in the forearm.
Arm Title
Dipyridamole
Arm Type
Active Comparator
Arm Description
To determine if there is an increase in adenosine interstitial levels in the forearm.
Arm Title
Ticagrelor
Arm Type
Experimental
Arm Description
To determine if there is an increase in adenosine interstitial levels in the forearm.
Intervention Type
Drug
Intervention Name(s)
Adenosine
Other Intervention Name(s)
Adenocard
Intervention Description
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,
Primary Outcome Measure Information:
Title
Interstitial levels of adenosine
Time Frame
After each dose of intrabrachial adenosine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects will be healthy volunteers, without significant pulmonary, cardiovascular gastrointestinal, hematological or renal diseases
Not taking any regular medications
Able to provide signed consent prior to study participation.
Exclusion Criteria:
History of asthma
Pregnancy
Exposure to an investigational drug in the last 2 months.
Known hypersensitivity to study medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Italo Biaggioni, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Autonomic Dysfunction Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Ticagrelor vs. Dipyridamole on Adenosine Uptake
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