UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	management of antithrombotic therapy for nonvariceal upper gastrointestinal bleeding
Title of the study (Brief title)	Antithrombotic therapy and nonvariceal upper gastrointestinal bleeding
Region	Japan

Condition
Condition	nonvariceal upper gastrointestinal bleeding
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the management of antithrombotic treatment in nonvariceal upper gastrointestinal bleeding
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Rebleeding rate after resumption of antithrombotic treatment
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	1)Patient who underwent endoscopy for acute upper gastrointestinal bleeding with proved source of blood losses in upper gastrointestinal tract 2)Patient who was taking antithrombotic medication 3)Patient who was explained about the study, understood it, and gave the consent form
Key exclusion criteria	Patient with 1.pregnant or lactating women and women who may be pregnant 2. allrgic to proton pump inhibitor 3.an uncontrollable heart trouble (myocardial infarction, heart failure, or arrhythmia) 4.renal disease, Cre >2mg/dl 5.liver disease, ALT levels that were more than 2.5 times the upper limit of the normal range
Target sample size	100

Research contact person
Name of lead principal investigator	Ichida chikamasa
Organization	shonan kamakura general hospital
Division name	department of gastroenterology
Address	1370-1 okamoto,kamakura, kanagawa, japan
TEL	0467-46-1717
Email	ichikamasa@yahoo.co.jp

Public contact
Name of contact person	Ichida chikamasa
Organization	shonan kamakura general hospital
Division name	department of gastroenterology
Address	1370-1 okamoto,kamakura, kanagawa, japan
TEL	0467-46-1717
Homepage URL
Email	ichikamasa@yahoo.co.jp

Sponsor
Institute	shonan kamakura general hospital
Institute
Department

Funding Source
Organization	shonan kamakura general hospital
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	2016 Year 08 Month 03 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 07 Month 20 Day
Anticipated trial start date	2016 Year 08 Month 03 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	A study participant is absent at present.

Management information
Registered date	2016 Year 08 Month 03 Day
Last modified on	2016 Year 08 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027025