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Effect of Ticagrelor vs. Dipyridamole on Adenosine Uptake

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01690884
First Posted: September 24, 2012
Last Update Posted: January 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Italo Biaggioni, Vanderbilt University
  Purpose
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.

Condition Intervention Phase
Coronary Artery Disease Drug: Adenosine Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Ticagrelor and Adenosine Uptake. Phase II Study Comparing the Effects of Ticagrelor vs Dipyridamole on Adenosine Uptake

Resource links provided by NLM:


Further study details as provided by Italo Biaggioni, Vanderbilt University:

Primary Outcome Measures:
  • Interstitial levels of adenosine [ Time Frame: After each dose of intrabrachial adenosine ]

Enrollment: 28
Study Start Date: August 2012
Study Completion Date: January 2017
Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
To determine if there is an increase in adenosine interstitial levels in the forearm.
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,
Other Name: Adenocard
Active Comparator: Dipyridamole
To determine if there is an increase in adenosine interstitial levels in the forearm.
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,
Other Name: Adenocard
Experimental: Ticagrelor
To determine if there is an increase in adenosine interstitial levels in the forearm.
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,
Other Name: Adenocard

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01690884


Locations
United States, Tennessee
Autonomic Dysfunction Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Italo Biaggioni, MD Vanderbilt University Medical Center
  More Information

Responsible Party: Italo Biaggioni, Professor of Medicine and Pharmacology, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01690884     History of Changes
Other Study ID Numbers: 120477
First Submitted: August 27, 2012
First Posted: September 24, 2012
Last Update Posted: January 18, 2017
Last Verified: January 2017

Keywords provided by Italo Biaggioni, Vanderbilt University:
Adenosine
Ticagrelor
Microdialysis

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Ticagrelor
Adenosine
Dipyridamole
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Platelet Aggregation Inhibitors