CClinicalTrials.gg
Status unknownNCT01331902Updated Apr 8, 2011

Comparison of Hyperemic Efficacy Between Nicorandil and Adenosine for Fractional Flow Reserve (FFR) Measurement

A Phase 4 interventional study of Maximal Hyperemia with Adenosine Followed by Nicorandil and Maximal Hyperemia with Nicorandil Followed by Adenosine in Coronary Artery Disease and Myocardial Ischemia, sponsored by Seoul National University Hospital. Status unknown at 1 site in Korea, Republic of. Per ClinicalTrials.gov, last updated 2011-04-08.

Sponsored by Seoul National University Hospital · Phase 4, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Apr 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
200
Allocation
Randomized
Sex
All
01

Study summary

The purpose of this study is to evaluate the efficacy of nicorandil in the achievement of maximal coronary hyperemia compared with adenosine.

02

Conditions studied

  • Coronary Artery Disease
  • Myocardial Ischemia

Keywords

  • Adenosine
  • Nicorandil
  • Fractional Flow Reserve
  • Maximal Hyperemia
03

In context

Coronary Artery Disease

5,596 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.

This study's planned enrollment of 200 is above the median of 123 across 3,435 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • non -infarct related, patients with moderate coronary artery stenosis
  • normal left ventricular ejection fraction on echocardiogram

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 4
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Adenosine Followed by Nicorandil

    Other: Maximal Hyperemia with Adenosine Followed by Nicorandil

  • Experimental
    Nicorandil Followed by Adenosine

    Other: Maximal Hyperemia with Nicorandil Followed by Adenosine

Interventions

  • OtherMaximal Hyperemia with Adenosine Followed by Nicorandil

    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).

  • OtherMaximal Hyperemia with Nicorandil Followed by Adenosine

    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).

06

What researchers measure

Primary outcomes

  1. Fractional Flow Reserve at Maximal Hyperemia

    Time frame: 1 day

Secondary outcomes

  1. Time to Maximal Hyperemia

    Time frame: 1 day

  2. Changes in Heart Rate

    Time frame: 1 day

07

Study locations

1 of 1 sites recruiting
  • Cardiovascular Center, Seoul National University Hospital
    Seoul, Korea, Republic of
    Recruiting
08

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01331902
Lead sponsor
Seoul National University Hospital
Collaborators
Seoul National University Boramae Hospital, Inje University Ilsan Paik Hospital, Keimyung University Dongsan Medical Center
First posted
Apr 8, 2011
Start date
Mar 2011
Primary completion
Sep 2011 (estimated)
Completion
Sep 2011 (estimated)
Last update
Apr 8, 2011

Study contacts

Ho-Jun Jang, MD
Contact
wingal@naver.com
82-2-2072-3757
Bon-Kwan Koo, MD.PhD
Contact
bkkoo@snu.ac.kr
82-2-2072-2062
Bon-Kwon Koo, MD. PhD
study chair · Department of Internal Medicine, Cardiovascular Center, Seoul National University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.

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