UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027846 |
|---|---|
| Receipt number | 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 11:37:16 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
takanori.kusuyama@nifty.ne.jp
Sponsor or person
Institute
Tsukazaki Hospital Department of Cardiology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031903
