Effect of Ticagrelor vs. Dipyridamole on Adenosine Uptake

Study Overview
=================
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.

Official Title
-----------------
Ticagrelor and Adenosine Uptake. Phase II Study Comparing the Effects of Ticagrelor vs Dipyridamole on Adenosine Uptake

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Drug: Adenosine


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>To determine if there is an increase in adenosine interstitial levels in the forearm. | Drug: Adenosine<br>* 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,<br>* Other names: Adenocard;|
| Active Comparator: Dipyridamole<br>To determine if there is an increase in adenosine interstitial levels in the forearm. | Drug: Adenosine<br>* 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,<br>* Other names: Adenocard;|
| Experimental: Ticagrelor<br>To determine if there is an increase in adenosine interstitial levels in the forearm. | Drug: Adenosine<br>* 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,<br>* Other names: Adenocard;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interstitial levels of adenosine |  | After each dose of intrabrachial adenosine | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adenosine, Ticagrelor, Microdialysis