Effect of Ticagrelor vs. Dipyridamole on Adenosine Uptake

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Vanderbilt University
Sponsor:
Information provided by (Responsible Party):
Italo Biaggioni, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01690884
First received: August 27, 2012
Last updated: February 12, 2014
Last verified: February 2014
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 Vanderbilt University:

Primary Outcome Measures:
  • Interstitial levels of adenosine [ Time Frame: After each dose of intrabrachial adenosine ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: August 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: March 2015 (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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01690884

Contacts
Contact: Italo Biaggioni, MD (615)936-3420 adc.research@vanderbilt.edu

Locations
United States, Tennessee
Autonomic Dysfunction Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Italo Biaggioni, M.D.    615-343-8010    adc.research@vanderbilt.edu   
Contact: Alfredo Gamboa, M.D.    (615)-343-3649    adc.research@vanderbilt.edu   
Principal Investigator: Italo Biaggioni, M.D.         
Sub-Investigator: Alfredo Gamboa, M.D.         
Sub-Investigator: Cyndya Shibao, M.D.         
Sub-Investigator: Andre Diedrich, M.D., Ph.D         
Sub-Investigator: Satish Raj, M.D.         
Sub-Investigator: Luis Okamoto, MD         
Sub-Investigator: Rocio A Figueroa, MD         
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Italo Biaggioni, MD Vanderbilt University
  More Information

No publications provided

Responsible Party: Italo Biaggioni, Professor of Medicine and Pharmacology, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01690884     History of Changes
Other Study ID Numbers: 120477
Study First Received: August 27, 2012
Last Updated: February 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Adenosine
Dipyridamole
Ticagrelor
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Vasodilator Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Hematologic Agents
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents

ClinicalTrials.gov processed this record on July 22, 2014