UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015397
Receipt number R000017907
Scientific Title Registration study on Intervention
Date of disclosure of the study information 2014/10/09
Last modified on 2014/10/09 23:24:47

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Basic information

Public title

Registration study on Intervention

Acronym

KICS

Scientific Title

Registration study on Intervention

Scientific Title:Acronym

KICS

Region

Japan


Condition

Condition

Ischemic heart disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To determine the current status and prognosis of patients undergoing PCI

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

cardiovascular death, MI, stroke

Key secondary outcomes

hospitalization for UA or heart failure, revascularization


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who undergo PCI in Kumamoto University Hospital or affiliated hospitals

Key exclusion criteria

Patients who do not give consent

Target sample size

10000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hisao Ogawa

Organization

Kumamoto University

Division name

Department of Cardiovascular Medicine

Zip code


Address

1-1-1, Honjo, Chuo-ku, Kumamoto, Kumamoto, 860-8556, JAPAN

TEL

81963735175

Email

shokimot@kumamoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Seiji Hokimoto

Organization

Secretariat of KICS

Division name

Department of Cardiovascular Medicine

Zip code


Address

1-1-1, Honjo, Chuo-ku, Kumamoto

TEL

81-96-373-5175

Homepage URL


Email

shokimot@kumamoto-u.ac.jp


Sponsor or person

Institute

KICS

Institute

Department

Personal name



Funding Source

Organization

KICS

Organization

Division

Category of Funding Organization

Non profit foundation

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



Other administrative information

Date of disclosure of the study information

2014 Year 10 Month 09 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

Enrolling by invitation

Date of protocol fixation

2008 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2008 Year 06 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Co-therapy with clopidogrel and PPI was not associated with an increased risk of cardiovascular events in coronary heart disease patients


Management information

Registered date

2014 Year 10 Month 09 Day

Last modified on

2014 Year 10 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017907


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name