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Trial record 4 of 1176 for:    adenosine

Effect of Ticagrelor vs. Dipyridamole on Adenosine Uptake

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.
 
ClinicalTrials.gov Identifier: NCT01690884
Recruitment Status : Completed
First Posted : September 24, 2012
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Italo Biaggioni, Vanderbilt University

Tracking Information
First Submitted Date  ICMJE August 27, 2012
First Posted Date  ICMJE September 24, 2012
Last Update Posted Date February 28, 2018
Study Start Date  ICMJE August 2012
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2012)
Interstitial levels of adenosine [ Time Frame: After each dose of intrabrachial adenosine ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01690884 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Ticagrelor vs. Dipyridamole on Adenosine Uptake
Official Title  ICMJE Ticagrelor and Adenosine Uptake. Phase II Study Comparing the Effects of Ticagrelor vs Dipyridamole on Adenosine Uptake
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE 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
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    To determine if there is an increase in adenosine interstitial levels in the forearm.
    Intervention: Drug: Adenosine
  • Active Comparator: Dipyridamole
    To determine if there is an increase in adenosine interstitial levels in the forearm.
    Intervention: Drug: Adenosine
  • Experimental: Ticagrelor
    To determine if there is an increase in adenosine interstitial levels in the forearm.
    Intervention: Drug: Adenosine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 16, 2017)
28
Original Estimated Enrollment  ICMJE
 (submitted: September 18, 2012)
36
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01690884
Other Study ID Numbers  ICMJE 120477
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Italo Biaggioni, Vanderbilt University
Study Sponsor  ICMJE Vanderbilt University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Italo Biaggioni, MD Vanderbilt University Medical Center
PRS Account Vanderbilt University Medical Center
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP