UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035100 |
|---|---|
| Receipt number | R000040011 |
| 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 |
| Date of disclosure of the study information | 2018/12/01 |
| Last modified on | 2020/06/02 22:25:00 |
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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
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
kfujii350@hotmail.com
Sponsor or person
Institute
Higashi Takarazuka Satoh Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040011
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
