Coronary Artery DiseasePhase 4NCT00763009

Persantine: Variation in Response Trial

A Phase 4 study testing dipyridamole in people with Coronary Artery Disease, run by UConn Health at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Coronary Artery Disease
What is being tested?: dipyridamole
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteUnited States
Study dates: Sep 2002to Jul 2009
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

UCONN Health Center
Farmington, Connecticut, 06030

Other trials in United States

About this study

Read the 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.

Conditions: Coronary Artery Disease
Being tested: dipyridamole
Medical subject headings: Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

dipyridamoleDrug
Also called Persantine
0.28mg/kg over 4 minutes intravenously x three doses; totalling 0.84mg/kg intravenously

Study groups in NCT00763009
Study group	Role	What they receive
All subjects receive dipyridamole	Other	Compare to baseline Receives: Drug: dipyridamole

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 6-12 months

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2002Jul 2009

First posted30 Sep 2008 (estimated)
Study startSep 2002
Primary completionJul 2009
Study completionJul 2009

Why it stopped: Limited numbers of patients qualified for trial

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00763009
Sponsor's protocol ID: 02-202-1
Other IDs: A-13147.1
Status last verified: Mar 2018
First submitted: 24 Sep 2008
Last updated: 13 Apr 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Coronary Artery Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Persantine: Variation in Response Trial
ClinicalTrials.gov ID: NCT00763009
Acronym / sponsor ID: 02-202-1
Conditions: Coronary Artery Disease
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Limited numbers of patients qualified for trial
Enrolment: 8 participants (actual)
Lead sponsor: UConn HealthUniversity, hospital or other
Collaborators: United States Department of Defense
Study start: Sep 2002 (actual)
Primary completion: Jul 2009 (actual)
Study completion: Jul 2009 (actual)
First posted: 30 Sep 2008 (estimated)
Results: Posted 24 May 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
All subjects receive dipyridamole	Other	Drug: dipyridamoleCompare to baseline

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
dipyridamoleAlso: Persantine0.28mg/kg over 4 minutes intravenously x three doses; totalling 0.84mg/kg intravenously	Drug	All subjects receive dipyridamole

Primary outcome

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

1 secondary outcome

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

Results and safety

Results posted to the registry on 24 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Subjects Receive Dipyridamole	8	7

Primary outcome: 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

Population analysed: All patients responded. Function and Expression of the Transporter were therefore not performed. The study was terminated due to poor enrollment

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Subjects Receive Dipyridamole	0 of 8 (0%)	0 of 8 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael A Azrin, MD principal investigator

University of Connecticut

Bruce T Liang, MD study chair

University of Connecticut

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing dipyridamole in people with Coronary Artery Disease, run by UConn Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00763009.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2018.