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
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
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
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
