Effect of Ticagrelor vs. Dipyridamole on Adenosine Uptake

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01690884
• Other study ID #: 120477
• Status: Completed
• Phase: Phase 1
• First received: August 27, 2012
• Last updated: February 27, 2018
• Start date: August 2012
• Est. completion date: January 2017

Study information

• Verified date: February 2018
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Adenosine
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,

Locations

Country	Name	City	State
United States	Autonomic Dysfunction Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interstitial levels of adenosine		After each dose of intrabrachial adenosine