Persantine: Variation in Response Trial

NCT ID: NCT00763009

Last Updated: 2018-04-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2009-07-31

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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All subjects receive dipyridamole

Compare to baseline

Group Type OTHER

dipyridamole

Intervention Type DRUG

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

Interventions

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dipyridamole

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

Intervention Type DRUG

Other Intervention Names

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Persantine

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

UConn Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael A Azrin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Connecticut

Bruce T Liang, MD

Role: STUDY_CHAIR

University of Connecticut

Locations

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UCONN Health Center

Farmington, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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A-13147.1

Identifier Type: -

Identifier Source: secondary_id

02-202-1

Identifier Type: -

Identifier Source: org_study_id

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