UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	GI endoscopy and anticoagulant therapy -a multicenter obsevational study-
Title of the study (Brief title)	Osaka GI-anticoagulant (GIANT) study
Region	Japan

Condition
Condition	Patients who are treated with anticoagulant drugs requiring endoscopic biopsy or therapeutics
Classification by specialty	Medicine in general Gastroenterology Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the prevalence of GI bleeding after endoscopy or treatents in patients treated with anticoagulants.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Prevalence of GI bleeding within one month after the endoscopy or endoscopic treatment
Key secondary outcomes	1. Duration of hospitalization 2. Prevalence of cardiovascular and cerebro- and systemic vascular events after endoscopy or endoscopic treatment 3. Frequency of requiring re-endoscopy 4. Frequency of massive GI bleeding 5. Frequency of massive GI bleeding threatening life 6. Frequency of cerebrovascular bleeding

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) Patients taking warfarin or other antigocoagulant drugs (e.g., dabigatran). 2) Patients older than 20 years old. 3) Patients requiring endoscopic biopsy or treatment 4) Patients who gave written informed concent.
Key exclusion criteria	1) Patients with unstable vital sign with high risk of endoscopy. 2) Patients with apparent GI bleeding before endoscopy. 3)Pregnant, breast-feeding women and possibility of pregnancy 4)Patients who will perform endoscopic biopsy and treatment during the same hospitalization period 5)Patients who were considered not suitable to be included in this study by the physician.
Target sample size	450

Research contact person
Name of lead principal investigator	Tetsuo Takehara
Organization	Osaka University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL	06-6879-3621
Email	takehara@gh.med.osaka-u.ac.jp

Public contact
Name of contact person	Hideki Iijima
Organization	Osaka University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL	06-6879-3621
Homepage URL
Email	hiijima@gh.med.osaka-u.ac.jp

Sponsor
Institute	Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
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	2012 Year 10 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 09 Month 14 Day
Anticipated trial start date	2012 Year 09 Month 27 Day
Last follow-up date	2015 Year 12 Month 31 Day
Date of closure to data entry	2016 Year 06 Month 19 Day
Date trial data considered complete	2016 Year 06 Month 19 Day
Date analysis concluded	2018 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	DOAC administration showed similar post-procedural GI bleeding risk to VKA administration in patients undergoing endoscopic procedures, but it shortened the hospital stay.
Other related information	Patients taking anticoagulants and requiring endoscopic biopsy or treatment will be prospectively registered and will be assessed for the risk of GI bleeding and cerebrovascular events.

Management information
Registered date	2012 Year 10 Month 13 Day
Last modified on	2018 Year 08 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010682