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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000027846
Receipt No. R000031903
Scientific Title the efficacy of nicorandil in percutaneouns coronary intervention post procedure MI study
Date of disclosure of the study information 2017/06/21
Last modified on 2018/12/22

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Basic information
Public title the efficacy of nicorandil in percutaneouns coronary intervention post procedure MI study
Acronym PCI post procedure MI study
Scientific Title the efficacy of nicorandil in percutaneouns coronary intervention post procedure MI study
Scientific Title:Acronym PCI post procedure MI study
Region
Japan

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

Objectives
Narrative objectives1 The evaluation of the efficacy of nicorandil in post elective percutaneous coronary intervention myocardial infarction
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the difference of troponin I level betweeen before and after PCI
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 intracoronary injection of 1mg nicorandil before PCI.
Interventions/Control_2 intracoronary injection of 10ml normal saline before PCI
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
18 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria elective PCI patient
Key exclusion criteria None
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takanori Kusuyama
Organization Tsukazaki Hospital
Division name Department of Cardiology
Zip code
Address 68-1 Waku Aboshi-ku, Himeji, Hyogo Japan
TEL 079-272-8555
Email takanori.kusuyama@nifty.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takanori Kusuyama
Organization Tsukazaki Hospital
Division name Department of Cardiology
Zip code
Address 68-1 Waku Aboshi-ku, Himeji, Hyogo
TEL 079-272-8555
Homepage URL
Email takanori.kusuyama@nifty.ne.jp

Sponsor
Institute Tsukazaki Hospital Department of Cardiology
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 社会医療法人 三栄会 ツカザキ病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 21 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 Terminated
Date of protocol fixation
2017 Year 06 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 21 Day
Last follow-up date
2017 Year 12 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2018 Year 10 Month 30 Day

Other
Other related information

Management information
Registered date
2017 Year 06 Month 21 Day
Last modified on
2018 Year 12 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031903

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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