Effect of Ticagrelor vs. Dipyridamole on Adenosine Uptake

Phase 1

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: Adenosine

• Registration Number: NCT01690884
• Lead Sponsor: Vanderbilt University

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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-27
• Study First Submitted QC: 2012-09-18
• Study First Posted: 2012-09-24
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-27
• Last Update Posted: 2018-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Adenosine	To determine if there is an increase in adenosine interstitial levels in the forearm.
Dipyridamole	Adenosine	To determine if there is an increase in adenosine interstitial levels in the forearm.
Ticagrelor	Adenosine	To determine if there is an increase in adenosine interstitial levels in the forearm.

Primary Outcome Measures

Name	Time	Method
Interstitial levels of adenosine	After each dose of intrabrachial adenosine

Trial Locations

Locations (1)

Autonomic Dysfunction Center; 🇺🇸 Nashville, Tennessee, United States