Coronary Artery DiseasePhase 4NCT01331902
Comparison of Hyperemic Efficacy Between Nicorandil and Adenosine for Fractional Flow Reserve (FFR) Measurement
A Phase 4 study testing Maximal Hyperemia with Adenosine Followed by Nicorandil and Maximal Hyperemia with Nicorandil Followed by Adenosine in people with Coronary Artery Disease and Myocardial Ischemia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy of nicorandil in the achievement of maximal coronary hyperemia compared with adenosine. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease, Myocardial Ischemia
- What is being tested?
- Maximal Hyperemia with Adenosine Followed by Nicorandil and Maximal Hyperemia with Nicorandil Followed by Adenosine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2011to Sep 2011
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- non -infarct related, patients with moderate coronary artery stenosis
- normal left ventricular ejection fraction on echocardiogram
Who cannot join
- infarct-related arteries or clinically unstable state
- collateral blood flow to the target vessel is shown
- atrioventricular block on electrocardiogram
- reduced left ventricular ejection fraction (<50%) or left ventricular hypertrophy on echocardiogram
- contraindication of adenosine
- bronchial asthma
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Cardiovascular Center, Seoul National University Hospital
Seoul
Ho-Jun Jang, MD, 82-2-2072-3757, wingal@naver.com
Bon-Kwon Koo, MD.PhD, 82-2-2072-2062, bkkoo@snu.ac.kr
About this study
The purpose of this study is to evaluate the efficacy of nicorandil in the achievement of maximal coronary hyperemia compared with adenosine.
- Conditions
- Coronary Artery Disease, Myocardial Ischemia
- Being tested
- Maximal Hyperemia with Adenosine Followed by Nicorandil, Maximal Hyperemia with Nicorandil Followed by Adenosine
- Keywords
- Adenosine, Nicorandil, Fractional Flow Reserve, Maximal Hyperemia
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maximal Hyperemia with Adenosine Followed by NicorandilOther
Firstly FFR was measured with intravenous adenosine infusion (140 μg•min-1•kg-1) via femoral vein or antecubital vein. Secondly with intracoronary adenosine bolus injection (80μg, 40μg to LCA and RCA, respectively). Lastly with intracoronary nicorandil bolus injection (1mg followed by 2mg).
Maximal Hyperemia with Nicorandil Followed by AdenosineOther
Firstly FFR was measured with intracoronary nicorandil bolus injection (1mg followed by 2mg). Secondly with intravenous adenosine infusion (140 μg•min-1•kg-1) via femoral vein or antecubital vein. Lastly with intracoronary adenosine bolus injection (80μg, 40μg to LCA and RCA, respectively).
| Study group | Role | What they receive |
|---|---|---|
| Adenosine Followed by Nicorandil | Experimental | Not described Receives: Other: Maximal Hyperemia with Adenosine Followed by Nicorandil |
| Nicorandil Followed by Adenosine | Experimental | Not described Receives: Other: Maximal Hyperemia with Nicorandil Followed by Adenosine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional Flow Reserve at Maximal Hyperemia
Measured: 1 day
Secondary outcomes (2)
Time to Maximal Hyperemia
Measured: 1 day
Changes in Heart Rate
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionSep 2011 (estimated)
- Study completionSep 2011 (estimated)
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.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Boramae Hospital, Inje University Ilsan Paik Hospital, Keimyung University Dongsan Medical Center
- Investigators
- Bon-Kwon Koo, MD. PhD, Study chair, Department of Internal Medicine, Cardiovascular Center, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01331902
- Sponsor's protocol ID
- H-1101-069-348
- Status last verified
- Apr 2011
- First submitted
- 1 Apr 2011
- Last updated
- 8 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jang HJ, Koo BK, Lee HS, Park JB, Kim JH, Seo MK, Yang HM, Park KW, Nam CW, Doh JH, Kim HS. Safety and efficacy of a novel hyperaemic agent, intracoronary nicorandil, for invasive physiological assessments in the cardiac catheterization laboratory. Eur Heart J. 2013 Jul;34(27):2055-62. doi: 10.1093/eurheartj/eht040. Epub 2013 Feb 8.
PubMed 23396491
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Hyperemic Efficacy Between Nicorandil and Adenosine for Fractional Flow Reserve (FFR) Measurement
- ClinicalTrials.gov ID
- NCT01331902
- Acronym / sponsor ID
- H-1101-069-348
- Conditions
- Coronary Artery Disease, Myocardial Ischemia
- Keywords
- Adenosine, Nicorandil, Fractional Flow Reserve, Maximal Hyperemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Boramae Hospital, Inje University Ilsan Paik Hospital, Keimyung University Dongsan Medical Center
- Study start
- Mar 2011
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 8 Apr 2011 (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 purpose of this study is to evaluate the efficacy of nicorandil in the achievement of maximal coronary hyperemia compared with adenosine.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adenosine Followed by Nicorandil | Experimental | Other: Maximal Hyperemia with Adenosine Followed by Nicorandil |
| Nicorandil Followed by Adenosine | Experimental | Other: Maximal Hyperemia with Nicorandil Followed by Adenosine |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- non -infarct related, patients with moderate coronary artery stenosis
- normal left ventricular ejection fraction on echocardiogram
Key exclusion criteria (6 listed)
- infarct-related arteries or clinically unstable state
- collateral blood flow to the target vessel is shown
- atrioventricular block on electrocardiogram
- reduced left ventricular ejection fraction (<50%) or left ventricular hypertrophy on echocardiogram
- contraindication of adenosine
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 |
|---|---|---|
| Maximal Hyperemia with Adenosine Followed by NicorandilFirstly FFR was measured with intravenous adenosine infusion (140 μg•min-1•kg-1) via femoral vein or antecubital vein. Secondly with intracoronary adenosine bolus injection (80μg, 40μg to LCA and RCA, respectively). Lastly with intracoronary nicorandil bolus injection (1mg followed by 2mg). | Other | Adenosine Followed by Nicorandil |
| Maximal Hyperemia with Nicorandil Followed by AdenosineFirstly FFR was measured with intracoronary nicorandil bolus injection (1mg followed by 2mg). Secondly with intravenous adenosine infusion (140 μg•min-1•kg-1) via femoral vein or antecubital vein. Lastly with intracoronary adenosine bolus injection (80μg, 40μg to LCA and RCA, respectively). | Other | Nicorandil Followed by Adenosine |
Primary outcome
Fractional Flow Reserve at Maximal Hyperemia
Time frame: 1 day
2 secondary outcomes
Time to Maximal Hyperemia
Time frame: 1 day
Changes in Heart Rate
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2011.
- Derived from this study: PubMed 23396491Jang HJ, Koo BK, Lee HS, Park JB, Kim JH, Seo MK, Yang HM, Park KW, Nam CW, Doh JH, Kim HS. Safety and efficacy of a novel hyperaemic agent, intracoronary nicorandil, for invasive physiological assessments in the cardiac catheterization laboratory. Eur Heart J. 2013 Jul;34(27):2055-62. doi: 10.1093/eurheartj/eht040. Epub 2013 Feb 8.
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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.
Bon-Kwon Koo, MD. PhD study chair
Department of Internal Medicine, Cardiovascular Center, Seoul National University Hospital
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 Maximal Hyperemia with Adenosine Followed by Nicorandil and Maximal Hyperemia with Nicorandil Followed by Adenosine in people with Coronary Artery Disease and Myocardial Ischemia, run by Seoul National University Hospital at 1 site in South Korea.
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: status not confirmed, as of the sponsor's last update on 8 Apr 2011. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ho-Jun Jang, MD (82-2-2072-3757, wingal@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fractional Flow Reserve at Maximal Hyperemia (time frame: 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 NCT01331902, 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 8 Apr 2011.