Persantine: Variation in Response Trial

March 14, 2018 updated by: UConn Health
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

8

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • UCONN Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • Persantine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6-12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To Determine the Clinical Significance of Variations in Adenosine Transfer Function on Coronary Flow.
Time Frame: 6-12 months
6-12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UConn Health

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: Michael A Azrin, MD, University of Connecticut
  • Study Chair: Bruce T Liang, MD, University of Connecticut

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2002

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

September 24, 2008

First Submitted That Met QC Criteria

September 26, 2008

First Posted (Estimate)

September 30, 2008

Study Record Updates

Last Update Posted (Actual)

April 13, 2018

Last Update Submitted That Met QC Criteria

March 14, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02-202-1
  • A-13147.1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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