UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001610
Receipt number R000001937
Scientific Title Gastrointestinal bleeding complicating antiplatelet treatment after percutaneous coronary intervention(PCI)
Date of disclosure of the study information 2009/01/05
Last modified on 2011/01/03 07:22:28

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Basic information

Public title

Gastrointestinal bleeding complicating antiplatelet treatment after percutaneous coronary intervention(PCI)

Acronym

Gastrointestinal bleeding complicating antiplatelet treatment after PCI

Scientific Title

Gastrointestinal bleeding complicating antiplatelet treatment after percutaneous coronary intervention(PCI)

Scientific Title:Acronym

Gastrointestinal bleeding complicating antiplatelet treatment after PCI

Region

Japan


Condition

Condition

patients for indicated antiplatelet treatment after percutaneous coronary intervention(PCI)

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The current study attempted to compare the efficacy of omeprazole with omeprazole in patients indicated for antiplatelet treatment after PCI

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase IV


Assessment

Primary outcomes

The current study attempted to compare the efficacy of rabeprazole with omeprazole in patients indicated for antiplatelet treatment after PCI

Key secondary outcomes

upper gastrointestinal bleeding.
Gastrointestinal symptom(Gastrointesitinal Symptom Rating Scale).


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

endoscopic findings is normal and no symptom case:
they randomly divided into three treatment arms in each of the groups. Each group was randomly assigned to receive 10 mg omeprazole once a day after breakfast, 100 mg rebamipide 3 times per day after each meal, or no receiving drug during 6 months.

Interventions/Control_2

patients have endoscopic findings and/or symptom :
they randomly divided into two treatment arms in each of the groups. Each group was randomly assigned to receive 10 mg omeprazole once a day after breakfast, 100 mg rebamipide 3 times per day after each meal 6 months.

Interventions/Control_3

when patients have peptic uler, they received H. pylori eradication therapy. afer that, they receive 10 mg omeprazole once a day after breakfast.

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

patients indicated for antiplatelet treatment(aspirin and clopidogrel) after percutaneous coronary intervention(PCI)

Key exclusion criteria

Patients were excluded if patients had been malignant disease, previous upper abdominal surgery, neuropsychiatric disorder, organic brain damage, severe hepato-renal disorder, symptoms suggesting or were pregnant.

Target sample size

240


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yutaka Sasaki

Organization

Graduate School of Medicine Science, Kumamoto University

Division name

Department of Gastroenterology and Hepatology,

Zip code


Address

1-1-1 honjo, Kumamoto City, Kumamoto 860-8556, JAPAN

TEL

096-373-5150

Email



Public contact

Name of contact person

1st name
Middle name
Last name Kouichi Sakurai

Organization

Graduate School of Medicine Science, Kumamoto University

Division name

Department of Gastroenterology and Hepatology,

Zip code


Address

1-1-1 honjo, Kumamoto City, Kumamoto 860-8556, JAPAN

TEL

096-373-5150(+81-96-373-5150)

Homepage URL


Email



Sponsor or person

Institute

Graduate School of Medicine Science, Kumamoto University

Institute

Department

Personal name



Funding Source

Organization

Graduate School of Medicine Science, Kumamoto University

Organization

Division

Category of Funding Organization

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

2009 Year 01 Month 05 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

2008 Year 02 Month 29 Day

Date of IRB


Anticipated trial start date

2008 Year 09 Month 01 Day

Last follow-up date

2011 Year 03 Month 01 Day

Date of closure to data entry

2011 Year 03 Month 01 Day

Date trial data considered complete

2011 Year 09 Month 01 Day

Date analysis concluded

2012 Year 03 Month 01 Day


Other

Other related information



Management information

Registered date

2009 Year 01 Month 01 Day

Last modified on

2011 Year 01 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001937


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name