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Persantine: Variation in Response Trial

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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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Coronary Artery Disease
Intervention Drug: dipyridamole
Enrollment 8
Recruitment Details Study terminated due to difficulty enrolling
Pre-assignment Details Study terminated due to difficulty enrolling
Arm/Group Title All Subjects Receive Dipyridamole
Hide Arm/Group Description

There is only a single arm

dipyridamole: 0.28mg/kg over 4 minutes intravenously x three doses; totalling 0.84mg/kg intravenously

Period Title: Overall Study
Started 8
Completed 7
Not Completed 1
Reason Not Completed
Coronary Anatomy unsuitable             1
Arm/Group Title Dipyridamole
Hide Arm/Group Description Pre: Baseline Results prior to administration of Dipyridamole. Post: Results post adminsitration of Dipyridamole
Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
  37.5%
>=65 years
5
  62.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants
65  (7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
4
  50.0%
Male
4
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants
8
1.Primary Outcome
Title To Determine if There is a Subgroup of Patients That Have an Abnormal Adenosine Transporter Expression, or Abnormal Adenosine Transporter Protein Function.
Hide Description 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
Time Frame 6-12 months
Hide Outcome Measure Data
Hide Analysis Population Description

All patients responded. Function and Expression of the Transporter were therefore not performed.

The study was terminated due to poor enrollment

Arm/Group Title All Subjects Receive Dipyridamole
Hide Arm/Group Description:

There is only a single arm

dipyridamole: 0.28mg/kg over 4 minutes intravenously x three doses; totalling 0.84mg/kg intravenously

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title To Determine the Clinical Significance of Variations in Adenosine Transfer Function on Coronary Flow.
Hide Description [Not Specified]
Time Frame 6-12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated due to poor enrollment
Arm/Group Title All Subjects Receive Dipyridamole
Hide Arm/Group Description:
There is only a single arm dipyridamole: 0.28mg/kg over 4 minutes intravenously x three doses; totalling 0.84mg/kg intravenously
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Subjects Receive Dipyridamole
Hide Arm/Group Description

There is only a single arm

dipyridamole: 0.28mg/kg over 4 minutes intravenously x three doses; totalling 0.84mg/kg intravenously

All-Cause Mortality
All Subjects Receive Dipyridamole
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
All Subjects Receive Dipyridamole
Affected / at Risk (%)
Total   0/8 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Subjects Receive Dipyridamole
Affected / at Risk (%)
Total   0/8 (0.00%) 
Trial terminated early due to poor patient enrollment. All patients responded hemodynamically. Therefore, analysis of responders vs non-responders could not be performed. Adenosine transporter was not analyzed since there was no comparator group.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael Azrin
Organization: UCHC
Phone: 8606793343
EMail: azrin@uchc.edu
Layout table for additonal information
Responsible Party: UConn Health
ClinicalTrials.gov Identifier: NCT00763009    
Other Study ID Numbers: 02-202-1
A-13147.1
First Submitted: September 24, 2008
First Posted: September 30, 2008
Results First Submitted: May 10, 2016
Results First Posted: May 24, 2017
Last Update Posted: April 13, 2018