Overview

This trial is active, not recruiting.

Condition coronary artery disease
Treatment adenosine
Phase phase 2
Sponsor Vanderbilt University
Start date August 2012
End date November 2016
Trial size 36 participants
Trial identifier NCT01690884, 120477

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacodynamics study
Intervention model parallel assignment
Masking single blind (subject)
Arm
(Placebo Comparator)
To determine if there is an increase in adenosine interstitial levels in the forearm.
adenosine Adenocard
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,
(Active Comparator)
To determine if there is an increase in adenosine interstitial levels in the forearm.
adenosine Adenocard
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,
(Experimental)
To determine if there is an increase in adenosine interstitial levels in the forearm.
adenosine Adenocard
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 Outcomes

Measure
Interstitial levels of adenosine
time frame: After each dose of intrabrachial adenosine

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Ticagrelor and Adenosine Uptake. Phase II Study Comparing the Effects of Ticagrelor vs Dipyridamole on Adenosine Uptake
Principal investigator Italo Biaggioni, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Vanderbilt University.