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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001610
Receipt No. 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

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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
Institute Graduate School of Medicine Science, Kumamoto University
Institute
Department

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
URL(English) https://upload.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


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