UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004813 |
|---|---|
| Receipt number | R000005728 |
| Scientific Title | Risk and safety to stop antiplatelet (aspirin)to perform an initial diagnostic endoscopy |
| Date of disclosure of the study information | 2011/04/01 |
| Last modified on | 2017/06/08 20:31:27 |
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Basic information
Public title
Risk and safety to stop antiplatelet (aspirin)to perform an initial diagnostic endoscopy
Acronym
Risk and safety to stop aspirin to perform an endoscopy
Scientific Title
Risk and safety to stop antiplatelet (aspirin)to perform an initial diagnostic endoscopy
Scientific Title:Acronym
Risk and safety to stop aspirin to perform an endoscopy
Region
| Japan |
Condition
Condition
Coronary artery disease patients not to be stopped aspirin to perform an initial diagnostic endoscopy.
Classification by specialty
| Gastroenterology | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Risk and safety to stop aspirin to perform an initial diagnostic endoscopy.The decision to reverse or to stop this therapy, risking an adverse ischemic event.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
bleeding rate to be performed the endoscopic procedures(biopsy) and adverse ischemic event rate to stop aspirin.
Key secondary outcomes
Efficacy and safety to Cilostazol
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Aspirin Discontinue for a short period of time (3days) before the endoscopic procedure. after that, Cilostazol uses 2days before the procedure(biopsy).
Endoscopic morning day only stop cilostazol. From next day,aspirin starts in the management.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients are used to aspirin in the management coronary artery disease and can not stop aspirin therapy before the endoscopic procedure(biopsy)(patients may be at too high of a risk to safely stop aspirin).
Key exclusion criteria
Malignancy, Zollinger-Ellison syndrome, pregnancy, a history of esophago-gastric surgery, continue bleeding from the GI tract, can not use the cilostazol, and can not take informed consent.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Sasaki |
Organization
Graduate School of Medical Sciences, 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
sakurai@s3.kcn-tv.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | kouichi Sakurai |
Organization
Graduate School of Medical Sciences, 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
sakurai@s3.kcn-tv.ne.jp
Sponsor or person
Institute
Graduate School of Medical Sciences, Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
no
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
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
| 2011 | Year | 04 | Month | 01 | 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
| 2010 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2011 | 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
| 2011 | Year | 01 | Month | 03 | Day |
Last modified on
| 2017 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005728
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
