UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Hyperemic Efficacy of nicorandil for fractional flow reserve measurement in patients with stable coronary artery disease
Title of the study (Brief title)	Hyperemic efficacy of nicorandil
Region	Japan

Condition
Condition	ischemic heart disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This randomized, prospective, crossover study is designed to investigate the hyperemic effect of intravenous nicorandil for fractional flow reserve (FFR) measurement compared with intravenous adenosine in the same patients with consecutive randomized patient-blinded infusions of intravenous adenosine and intravenous nicorandil.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	FFR value
Key secondary outcomes	The time to hyperemia; the plateau time; fluctuation; the number of functionally significant stenoses (FFR<0.75, FFR less than or equal to 0.80); hemodynamic parameters, ECG change and symptoms during FFR measurement.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Medicine Maneuver
Interventions/Control_1	Fractional flow reserve measurement with adenosine followed by nicorandil
Interventions/Control_2	Fractional flow reserve measurement with nicorandil followed by adenosine
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	89 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with an angiographically intermediate lesion in a major epicardial coronary artery. Age between 20 and 89 years and signed informed consent.
Key exclusion criteria	Acute coronary syndrome within the previous 1 week,vessels with prior myocardial infarction, allergy to adenosine of nicorandil,asthma or chronic obstructive pulmonary disease on medical treatment, second or third degree atrioventricular block, severe valvular heart disease, acute decompensated heart failure, reduced left ventricular function (ejection fraction less than or equal to 30%), severe liver dysfunction, severe renal insufficiency, angle-closure glaucoma, patients who are taking phosphodiesterase type 5 (PDE5) Inhibitors, pregnancy, patients who were not suitable for enrollment
Target sample size	50

Research contact person
Name of lead principal investigator	Yoshio Kobayashi
Organization	Chiba University Graduate School of Medicine
Division name	Department of Cardiovascular Medicine
Address	1-8-1 Inohana, Chuo-ku, Chiba city, Chiba, Japan
TEL	043-226-2340
Email	y@chiba-u.jp

Public contact
Name of contact person	Takeshi Nishi
Organization	Chiba University Graduate School of Medicine
Division name	Department of Cardiovascular Medicine
Address	1-8-1 Inohana, Chuo-ku, Chiba city, Chiba, Japan
TEL	043-226-2340
Homepage URL
Email	tnishi@chiba-u.jp

Sponsor
Institute	Chiba University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Chiba University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 07 Day
Anticipated trial start date	2015 Year 10 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 10 Month 10 Day
Last modified on	2016 Year 12 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022304