Effect of Ticagrelor vs. Dipyridamole on Adenosine Uptake
This study is currently recruiting participants.
Verified September 2012 by Vanderbilt University
Sponsor:
Vanderbilt University
Information provided by (Responsible Party):
Italo Biaggioni, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01690884
First received: August 27, 2012
Last updated: September 18, 2012
Last verified: September 2012
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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: | September 2014 (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:
- 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
Contacts and Locations
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 | |
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: | September 18, 2012 |
| 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 May 16, 2013