Persantine: Variation in Response Trial

Phase 4

Terminated

• Conditions: Coronary Artery Disease
• Interventions: Drug: dipyridamole

• Registration Number: NCT00763009
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2002-09
• Study First Submitted: 2008-09-24
• Study First Submitted QC: 2008-09-26
• Study First Posted: 2008-09-30
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Results First Submitted: 2016-05-10
• Results First Submitted QC: 2017-04-24
• Results First Posted: 2017-05-24
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-14
• Last Update Posted: 2018-04-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All subjects receive dipyridamole	dipyridamole	Compare to baseline

Primary Outcome Measures

Name	Time	Method
To Determine if There is a Subgroup of Patients That Have an Abnormal Adenosine Transporter Expression, or Abnormal Adenosine Transporter Protein Function.	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

Name	Time	Method
To Determine the Clinical Significance of Variations in Adenosine Transfer Function on Coronary Flow.	6-12 months

Trial Locations

Locations (1)

UCONN Health Center; 🇺🇸 Farmington, Connecticut, United States