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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

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: dipyridamole Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Persantine: Variation in Response Trial
Actual Study Start Date : September 2002
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
All subjects receive dipyridamole
Compare to baseline
Drug: dipyridamole
0.28mg/kg over 4 minutes intravenously x three doses; totalling 0.84mg/kg intravenously
Other Name: Persantine




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. To Determine the Clinical Significance of Variations in Adenosine Transfer Function on Coronary Flow. [ Time Frame: 6-12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT00763009


Locations
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United States, Connecticut
UCONN Health Center
Farmington, Connecticut, United States, 06030
Sponsors and Collaborators
UConn Health
United States Department of Defense
Investigators
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Principal Investigator: Michael A Azrin, MD University of Connecticut
Study Chair: Bruce T Liang, MD University of Connecticut

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Responsible Party: UConn Health
ClinicalTrials.gov Identifier: NCT00763009    
Other Study ID Numbers: 02-202-1
A-13147.1
First Posted: September 30, 2008    Key Record Dates
Results First Posted: May 24, 2017
Last Update Posted: April 13, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Dipyridamole
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents