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

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 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


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

Value
https://center6.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