- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01690884
Effect of Ticagrelor vs. Dipyridamole on Adenosine Uptake
February 27, 2018 updated by: Italo Biaggioni, Vanderbilt University
Ticagrelor and Adenosine Uptake. Phase II Study Comparing the Effects of Ticagrelor vs Dipyridamole on Adenosine Uptake
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
28
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Tennessee
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Nashville, Tennessee, United States, 37232
- Autonomic Dysfunction Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
To determine if there is an increase in adenosine interstitial levels in the forearm.
|
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,
Other Names:
|
Active Comparator: Dipyridamole
To determine if there is an increase in adenosine interstitial levels in the forearm.
|
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,
Other Names:
|
Experimental: Ticagrelor
To determine if there is an increase in adenosine interstitial levels in the forearm.
|
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,
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Interstitial levels of adenosine
Time Frame: After each dose of intrabrachial adenosine
|
After each dose of intrabrachial adenosine
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Actual)
January 1, 2017
Study Completion (Actual)
January 1, 2017
Study Registration Dates
First Submitted
August 27, 2012
First Submitted That Met QC Criteria
September 18, 2012
First Posted (Estimate)
September 24, 2012
Study Record Updates
Last Update Posted (Actual)
February 28, 2018
Last Update Submitted That Met QC Criteria
February 27, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Coronary Artery Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Vasodilator Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Purinergic Agents
- Purinergic P1 Receptor Agonists
- Purinergic Agonists
- Adenosine
Other Study ID Numbers
- 120477
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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