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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
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Coronary Artery Disease focused on measuring Adenosine, Ticagrelor, Microdialysis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

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

First Posted
August 27, 2012
Last Updated
February 27, 2018
Sponsor
Vanderbilt University
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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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