Persantine: Variation in Response Trial

NCT00763009 | Terminated Phase 4 Results DMC FDA Drug

• 2 other identifiers: 02-202-1A-13147.1
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (1)

• To Determine the Clinical Significance of Variations in Adenosine Transfer Function on Coronary Flow.

  6-12 months

Study Arms (1)

All subjects receive dipyridamole

OTHER

Compare to baseline

Drug: dipyridamole

Interventions

dipyridamole DRUG

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

Also known as: Persantine

All subjects receive dipyridamole

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \> 21 years old
• Patient undergoing cardiac catheterization with planned PTCA or with a significant coronary lesion of either the LAD or Circumflex

You may not qualify if:

• 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

Sponsors & Collaborators

• UConn Health: lead
• United States Department of Defense: collaborator

Study Sites (1)

UCONN Health Center

Farmington, Connecticut, 06030, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Dipyridamole

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

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.

Results Point of Contact

• Title: Michael Azrin
• Organization: UCHC

azrin@uchc.edu

8606793343

Study Officials

• Michael A Azrin, MD

  University of Connecticut

  PRINCIPAL INVESTIGATOR

• Bruce T Liang, MD

  University of Connecticut

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2008
• First Posted: September 30, 2008
• Study Start: September 1, 2002
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: April 13, 2018
• Results First Posted: May 24, 2017

Record last verified: 2018-03

Locations

US (1)