UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011996
Receipt number R000013634
Scientific Title LinkagE between GAstrointestinal Symptom and CoronarY stenting study
Date of disclosure of the study information 2013/10/10
Last modified on 2013/10/09 08:43:43

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Basic information

Public title

LinkagE between GAstrointestinal Symptom and CoronarY stenting study

Acronym

LEGACY study

Scientific Title

LinkagE between GAstrointestinal Symptom and CoronarY stenting study

Scientific Title:Acronym

LEGACY study

Region

Japan


Condition

Condition

Coronary artery disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the safety and efficacy of Rabeprazole for gastrointestinal injury during dual antiplatelet therapy such as aspirin and clopidogrel or ticlopidine in patients who undergoing stent implantation

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

to examine cardiovascular events, and gastrointestinal lesions at 1 month between rabeprazole and placebo groups

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Double blind -all involved 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

rabeprazole (PPI) vs placebo

Interventions/Control_2

placebo

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

30 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

patients who undergoing coronary stent implantation within a month during dual anti platelet therapy
evaluation by Global Overall Symptom(GOS) score > / = 4

Key exclusion criteria

allergy to rabeprazole
severe liver, or renal dysfunction,
heart failure,
malignancy,
gastroduodenal injury,
taking warfarin,

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hisao Ogawa

Organization

Graduate School of Medical Sciences,Kumamoto University

Division name

Department of Cardiovascular Medicine

Zip code


Address

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

TEL

096-373-5175

Email

ogawah@kumamoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Seiji Hokimoto

Organization

Graduate School of Medical Sciences,Kumamoto University

Division name

Department of Cardiovascular Medicine

Zip code


Address

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

TEL

096-373-5175

Homepage URL


Email

shokimot@kumamoto-u.ac.jp


Sponsor or person

Institute

Graduate School of Medical Sciences,Kumamoto University

Institute

Department

Personal name



Funding Source

Organization

Graduate School of Medical Sciences,Kumamoto University

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


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

2013 Year 10 Month 10 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

Open public recruiting

Date of protocol fixation

2009 Year 07 Month 13 Day

Date of IRB


Anticipated trial start date

2010 Year 02 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



Management information

Registered date

2013 Year 10 Month 09 Day

Last modified on

2013 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=R000013634


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name