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Persantine: Variation in Response Trial

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: NCT00763009
Recruitment Status : Terminated (Limited numbers of patients qualified for trial)
First Posted : September 30, 2008
Results First Posted : May 24, 2017
Last Update Posted : April 13, 2018
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
UConn Health

Tracking Information
First Submitted Date  ICMJE September 24, 2008
First Posted Date  ICMJE September 30, 2008
Results First Submitted Date  ICMJE May 10, 2016
Results First Posted Date  ICMJE May 24, 2017
Last Update Posted Date April 13, 2018
Actual Study Start Date  ICMJE September 2002
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2017)
To Determine if There is a Subgroup of Patients That Have an Abnormal Adenosine Transporter Expression, or Abnormal Adenosine Transporter Protein Function. [ Time Frame: 6-12 months ]
To determine if there is a subgroup of patients that have an abnormal adenosine transporter expression, or abnormal adenosine transporter protein function. All were responsive Study terminated due to difficulty enrolling
Original Primary Outcome Measures  ICMJE
 (submitted: September 26, 2008)
To Determine if There is a Subgroup of Patients That Have an Abnormal Adenosine Transporter Expression, or Abnormal Adenosine Transporter Protein Function. [ Time Frame: 6-12 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2008)
To Determine the Clinical Significance of Variations in Adenosine Transfer Function on Coronary Flow. [ Time Frame: 6-12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Persantine: Variation in Response Trial
Official Title  ICMJE Persantine: Variation in Response Trial
Brief Summary The primary objective of this study is to understand why different people respond differently to the medication Persantine. The effects of Persantine will be evaluated by performing echocardiograms, blood tests and by measuring the flow of blood in the arteries of the heart in patients undergoing a clinically indicated percutaneous coronary intervention.
Detailed Description Participants will receive three doses of Persantine intravenously for the research study. Before and after receiving the Persantine doses, patients will have an echocardiogram and coronary artery blood flow will be measured. Blood tests,measure the function of the adenosine transporter. In addition variations in the gene for the adenosine transporter will be evaluated.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE Drug: dipyridamole
0.28mg/kg over 4 minutes intravenously x three doses; totalling 0.84mg/kg intravenously
Other Name: Persantine
Study Arms  ICMJE All subjects receive dipyridamole
Compare to baseline
Intervention: Drug: dipyridamole
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 Terminated
Actual Enrollment  ICMJE
 (submitted: April 24, 2017)
8
Original Estimated Enrollment  ICMJE
 (submitted: September 26, 2008)
56
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients > 21 years old
  • Patient undergoing cardiac catheterization with planned PTCA or with a significant coronary lesion of either the LAD or Circumflex

Exclusion Criteria:

  • Theophylline or oral Persantine use in 24hrs
  • Second or third degree AV block, or sick sinus syndrome without a functioning pacemaker
  • Active asthma or bronchospasm
  • Patients with severe hepatic insufficiency
  • Patients experiencing an acute transmural infarction at the time of the index visit
  • Conditions that are known to affect resistive vessel function or myocardial flow
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT00763009
Other Study ID Numbers  ICMJE 02-202-1
A-13147.1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UConn Health
Study Sponsor  ICMJE UConn Health
Collaborators  ICMJE United States Department of Defense
Investigators  ICMJE
Principal Investigator: Michael A Azrin, MD University of Connecticut
Study Chair: Bruce T Liang, MD University of Connecticut
PRS Account UConn Health
Verification Date March 2018

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