UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Risk and safety to stop antiplatelet (aspirin)to perform an initial diagnostic endoscopy
Title of the study (Brief title)	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	Yutaka Sasaki
Organization	Graduate School of Medical Sciences, Kumamoto University
Division name	Department of Gastroenterology and Hepatology
Address	1-1-1 Honjo, Kumamoto City, Kumamoto 860-8556, Japan
TEL	096-373-5150
Email	sakurai@s3.kcn-tv.ne.jp

Public contact
Name of contact person	kouichi Sakurai
Organization	Graduate School of Medical Sciences, Kumamoto University
Division name	Department of Gastroenterology and Hepatology
Address	1-1-1 honjo, Kumamoto City, Kumamoto 860-8556, JAPAN
TEL	096-373-5150(+81-96-373-5150)
Homepage URL
Email	sakurai@s3.kcn-tv.ne.jp

Sponsor
Institute	Graduate School of Medical Sciences, Kumamoto University
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2010 Year 12 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005728