Coronary Artery DiseasePhase 3NCT01809743
Regadenoson and Adenosine
A Phase 3 study testing Regadenoson central -central, Regadenoson peripheral - peripheral and Regadenoson central - peripheral in people with Coronary Artery Disease, run by Lokien van Nunen at 1 site in Netherlands.
Trial summary
The aim of the study is to test the accuracy of Regadenoson to induce maximal and steady state hyperemia as compared to central venous infusion of adenosine for assessing fractional flow reserve. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Regadenoson central -central, Regadenoson peripheral - peripheral and Regadenoson central - peripheral
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2013to Oct 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years
- Scheduled for invasive measurement of FFR for diagnostic and interventional purposes in proximal or mid segments of a coronary artery
Who cannot join
- Severe aortic valve stenosis
- History of severe COPD
- Syncope or bradycardia (less than 50 beats/min)
- Known conduction disturbances (2nd-3rd degree heart-block, sick sinus without pacemaker or long QT-syndrome)
- Severe hypotension (RR <90 mmHg)
- Patients in whom no access to the coronary circulation can be obtained by the femoral artery or in whom femoral access was problematic
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- Coronary anatomy not suitable for FFR measurement (extremely tortuous or calcified coronary vessels)
- Previous coronary bypass surgery
- Recent ST elevation myocardial infarction (<5 days)
- Recent non-ST elevation myocardial infarction (<5 days) if the peak CK is >1000 IU
- Inability to provide informed consent
- Pregnancy
- Use of methylxanthines (in the last 12 hours)
- Use of Dipyridamol (in the last 48 hours)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Regadenoson (Rapiscan) and Central Intravenous Adenosine for Measurement of Fractional Flow Reserve
The aim of the study is to test the accuracy of Regadenoson to induce maximal and steady state hyperemia as compared to central venous infusion of adenosine for assessing fractional flow reserve. (adenosine is considered to be the gold standard)and to investigate the time intervals of maximum hyperemia induced by centrally and peripherally administered Regadenoson.
- Conditions
- Coronary Artery Disease
- Being tested
- Regadenoson central -central, Regadenoson peripheral - peripheral, Regadenoson central - peripheral, Regadenoson peripheral - central, Adenosine
- Keywords
- Coronary artery disease, Regadenoson, Adenosine, Maximal hyperemia, Fractional flow reserve, FFR
- 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.
Regadenoson central -centralDrug
To test the accuracy of Regadenoson to induce maximal and steady state hyperemia as compared to central venous infusion of adenosine for assessing fractional flow reserve. (adenosine is considered to be the golden standard).
Regadenoson peripheral - peripheralDrug
To test the accuracy of Regadenoson to induce maximal and steady state hyperemia as compared to central venous infusion of adenosine for assessing fractional flow reserve. (adenosine is considered to be the golden standard).
Regadenoson central - peripheralDrug
To test the accuracy of Regadenoson to induce maximal and steady state hyperemia as compared to central venous infusion of adenosine for assessing fractional flow reserve. (adenosine is considered to be the golden standard).
Regadenoson peripheral - centralDrug
To test the accuracy of Regadenoson to induce maximal and steady state hyperemia as compared to central venous infusion of adenosine for assessing fractional flow reserve. (adenosine is considered to be the golden standard).
AdenosineDrug
Fractional flow reserve is measured by inducing hyperaemia using central adenosine infusion.
| Study group | Role | What they receive |
|---|---|---|
| Regadenoson central - peripheral | Active comparator | First bolus regadenoson administered central, second bolus administered peripheral Receives: Drug: Regadenoson central - peripheral; Drug: Adenosine |
| Regadenoson peripheral - central | Active comparator | First bolus regadenoson administered peripheral, second bolus administered central Receives: Drug: Regadenoson peripheral - central; Drug: Adenosine |
| Regadenoson central - central | Active comparator | First bolus regadenoson administered central, second bolus administered central Receives: Drug: Regadenoson central -central; Drug: Adenosine |
| Regadenoson peripheral - peripheral | Active comparator | First bolus regadenoson administered peripheral, second bolus administered peripheral Receives: Drug: Regadenoson peripheral - peripheral; Drug: Adenosine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the accuracy of Regadenoson to induce maximal and steady state hyperemia
To test the accuracy of Regadenoson to induce maximal and steady state hyperemia as compared to central venous infusion of adenosine for assessing fractional flow reserve. (adenosine is considered to be the gold standard).
Measured: participants will be followed up during hospital stay, an expected average of 1 day
Secondary outcomes (1)
time intervals of maximum hyperemia
To investigate the time intervals of maximum hyperemia induced by centrally and peripherally administered Regadenoson.
Measured: participants will be followed up during hospital stay, an expected average of 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2013 (estimated)
- Study startJan 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lokien van Nunen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lokien van Nunen, Catharina Ziekenhuis Eindhoven
- Investigators
- Nico H.J. Pijls, MD, PhD, Principal investigator, Catharina Ziekenhuis EindhovenLokien X van Nunen, MD, Study director, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01809743
- Sponsor's protocol ID
- NL42049.060.12
- Status last verified
- Nov 2013
- First submitted
- 18 Dec 2012
- Last updated
- 13 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
van Nunen LX, Lenders GD, Schampaert S, van 't Veer M, Wijnbergen I, Brueren GR, Tonino PA, Pijls NH. Single bolus intravenous regadenoson injection versus central venous infusion of adenosine for maximum coronary hyperaemia in fractional flow reserve measurement. EuroIntervention. 2015 Dec;11(8):905-13. doi: 10.4244/EIJY14M08_10.
PubMed 25136887
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Regadenoson (Rapiscan) and Central Intravenous Adenosine for Measurement of Fractional Flow Reserve
- ClinicalTrials.gov ID
- NCT01809743
- Acronym / sponsor ID
- NL42049.060.12
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, Regadenoson, Adenosine, Maximal hyperemia, Fractional flow reserve, FFR
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Lokien van NunenUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 13 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to test the accuracy of Regadenoson to induce maximal and steady state hyperemia as compared to central venous infusion of adenosine for assessing fractional flow reserve. (adenosine is considered to be the gold standard)and to investigate the time intervals of maximum hyperemia induced by centrally and peripherally administered Regadenoson.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Regadenoson central - peripheral | Active comparator | Drug: Regadenoson central - peripheral, Drug: AdenosineFirst bolus regadenoson administered central, second bolus administered peripheral |
| Regadenoson peripheral - central | Active comparator | Drug: Regadenoson peripheral - central, Drug: AdenosineFirst bolus regadenoson administered peripheral, second bolus administered central |
| Regadenoson central - central | Active comparator | Drug: Regadenoson central -central, Drug: AdenosineFirst bolus regadenoson administered central, second bolus administered central |
| Regadenoson peripheral - peripheral | Active comparator | Drug: Regadenoson peripheral - peripheral, Drug: AdenosineFirst bolus regadenoson administered peripheral, second bolus administered peripheral |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-80 years
- Scheduled for invasive measurement of FFR for diagnostic and interventional purposes in proximal or mid segments of a coronary artery
Key exclusion criteria (14 listed)
- Severe aortic valve stenosis
- History of severe COPD
- Syncope or bradycardia (less than 50 beats/min)
- Known conduction disturbances (2nd-3rd degree heart-block, sick sinus without pacemaker or long QT-syndrome)
- Severe hypotension (RR <90 mmHg)
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 |
|---|---|---|
| Regadenoson central -centralTo test the accuracy of Regadenoson to induce maximal and steady state hyperemia as compared to central venous infusion of adenosine for assessing fractional flow reserve. (adenosine is considered to be the golden standard). | Drug | Regadenoson central - central |
| Regadenoson peripheral - peripheralTo test the accuracy of Regadenoson to induce maximal and steady state hyperemia as compared to central venous infusion of adenosine for assessing fractional flow reserve. (adenosine is considered to be the golden standard). | Drug | Regadenoson peripheral - peripheral |
| Regadenoson central - peripheralTo test the accuracy of Regadenoson to induce maximal and steady state hyperemia as compared to central venous infusion of adenosine for assessing fractional flow reserve. (adenosine is considered to be the golden standard). | Drug | Regadenoson central - peripheral |
| Regadenoson peripheral - centralTo test the accuracy of Regadenoson to induce maximal and steady state hyperemia as compared to central venous infusion of adenosine for assessing fractional flow reserve. (adenosine is considered to be the golden standard). | Drug | Regadenoson peripheral - central |
| AdenosineFractional flow reserve is measured by inducing hyperaemia using central adenosine infusion. | Drug | Regadenoson central - central, Regadenoson central - peripheral, Regadenoson peripheral - central, Regadenoson peripheral - peripheral |
Primary outcome
the accuracy of Regadenoson to induce maximal and steady state hyperemia
Time frame: participants will be followed up during hospital stay, an expected average of 1 day
To test the accuracy of Regadenoson to induce maximal and steady state hyperemia as compared to central venous infusion of adenosine for assessing fractional flow reserve. (adenosine is considered to be the gold standard).
1 secondary outcome
time intervals of maximum hyperemia
Time frame: participants will be followed up during hospital stay, an expected average of 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2013.
- Derived from this study: PubMed 25136887van Nunen LX, Lenders GD, Schampaert S, van 't Veer M, Wijnbergen I, Brueren GR, Tonino PA, Pijls NH. Single bolus intravenous regadenoson injection versus central venous infusion of adenosine for maximum coronary hyperaemia in fractional flow reserve measurement. EuroIntervention. 2015 Dec;11(8):905-13. doi: 10.4244/EIJY14M08_10.
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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.
Nico H.J. Pijls, MD, PhD principal investigator
Catharina Ziekenhuis Eindhoven
Lokien X van Nunen, MD study director
Catharina Ziekenhuis Eindhoven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Regadenoson central -central, Regadenoson peripheral - peripheral and Regadenoson central - peripheral in people with Coronary Artery Disease, run by Lokien van Nunen at 1 site in Netherlands.
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 14 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: finished, as of the sponsor's last update on 13 Nov 2013. 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 Netherlands. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the accuracy of Regadenoson to induce maximal and steady state hyperemia (time frame: participants will be followed up during hospital stay, an expected average of 1 day). 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 NCT01809743, which also lists 1 linked publication.
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 Nov 2013; AzTrials last refreshed its copy on 28 Oct 2026.