Effect of Ticagrelor vs. Dipyridamole on Adenosine Uptake
Information source: Vanderbilt University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Coronary Artery Disease
Intervention: Adenosine (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Vanderbilt University Official(s) and/or principal investigator(s): Italo Biaggioni, MD, Principal Investigator, Affiliation: Vanderbilt University
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.
Clinical Details
Official title: Ticagrelor and Adenosine Uptake. Phase II Study Comparing the Effects of Ticagrelor vs Dipyridamole on Adenosine Uptake
Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)
Primary outcome: Interstitial levels of adenosine
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Autonomic Dysfunction Center, Nashville, Tennessee 37232, United States
Additional Information
Starting date: August 2012
Last updated: July 13, 2015
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