UMIN-CTR Clinical Trial

Basic information
Public title	The Utility and Validity of Intracoronary Administration of Nicorandil Alone for the Measurement of Fractional Flow Reserve in Patients With Intermediate Coronary Stenosis
Acronym	Intracoronary Nicorandil for the Measurement of Fractional Flow Reserve
Scientific Title	The Utility and Validity of Intracoronary Administration of Nicorandil Alone for the Measurement of Fractional Flow Reserve in Patients With Intermediate Coronary Stenosis
Scientific Title:Acronym	Intracoronary Nicorandil for the Measurement of Fractional Flow Reserve
Region	Japan

Condition
Condition	Angina Pectoris
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to investigate the usefulness and safety of intracoronary nicorandil (ICN) alone compared with intravenous adenosine 5'-triphosphate (IVATP) and ICN during IVATP for the achievement of maximal hyperemia in patients with suspected angina pectoris.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Reliability for FFR value after administration of each drug
Key secondary outcomes	The incidence of side effect for each drug

Base
Study type	Interventional

Study design
Basic design	Factorial
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	6
Purpose of intervention	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	2mg of intracoronary nicorandil
Interventions/Control_2	continuous intravenous infusion of ATP 150microg/kg/min for 2 minutes
Interventions/Control_3	continuous intravenous infusion of ATP 210microg/kg/min for 2 minutes
Interventions/Control_4	0.5mg of intracoronary nicorandil in addition to continuous intravenous infusion of ATP 150microg/kg/min for 2 minutes
Interventions/Control_5	1mg of intracoronary nicorandil in addition to continuous intravenous infusion of ATP 150microg/kg/min for 2 minutes
Interventions/Control_6	2mg of intracoronary nicorandil in addition to continuous intravenous infusion of ATP 150microg/kg/min for 2 minutes
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who have a 50 to 75% focal stenosis in the coronary artery on diagnostic coronary angiography
Key exclusion criteria	younger than 20 years old older than 80 years old acute coronary syndrome heart failure left main stenosis post coronary artery bypass graft
Target sample size	220

Research contact person
Name of lead principal investigator	1st name Kenichi Middle name Last name Fujii
Organization	Higashi Takarazuka Satoh Hospital
Division name	Department of Cardiology
Zip code	665-0873
Address	2-1 Nagao-cho, Takarazuka-city
TEL	0797882200
Email	kfujii350@hotmail.com

Public contact
Name of contact person	1st name Kenichi Middle name Last name Fujii
Organization	Higashi Takarazuka Satoh Hospital
Division name	Department of Cardiology
Zip code	665-0873
Address	2-1 Nagao-cho, Takarazuka-city
TEL	0797882200
Homepage URL
Email	kfujii350@hotmail.com

Sponsor
Institute	Higashi Takarazuka Satoh Hospital
Institute
Department

Funding Source
Organization	Higashi Takarazuka Satoh Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Higashi Takarazuka Satoh Hospital
Address	2-1 Nagao-cho, Takarazuka-city
Tel	0797882200
Email	kfujii350@hotmail.com

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	2018 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 09 Day
Date of IRB	2017 Year 08 Month 30 Day
Anticipated trial start date	2017 Year 10 Month 01 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 12 Month 01 Day
Last modified on	2020 Year 06 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040011