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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035100
Receipt No. R000040011
Official scientific title of the study The Utility and Validity of Intracoronary Administration of Nicorandil Alone for the Measurement of Fractional Flow Reserve in Patients With Intermediate Coronary Stenosis
Date of disclosure of the study information 2018/12/01
Last modified on 2018/12/01

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Basic information
Official scientific title of the study The Utility and Validity of Intracoronary Administration of Nicorandil Alone for the Measurement of Fractional Flow Reserve in Patients With Intermediate Coronary Stenosis
Title of the study (Brief title) 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 Kenihi Fujii
Organization Higashi Takarazuka Satoh Hospital
Division name Department of Cardiology
Address 2-1 Nagao-cho, Takarazuka-city
TEL 0797882200
Email kfujii350@hotmail.com

Public contact
Name of contact person Kenichi Fujii
Organization Higashi Takarazuka Satoh Hospital
Division name Department of Cardiology
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)

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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2017 Year 08 Month 09 Day
Anticipated trial start date
2017 Year 10 Month 01 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
2018 Year 12 Month 01 Day
Last modified on
2018 Year 12 Month 01 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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