UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study to assess the safety of non-vitamin K antagonist oral anticoagulants on high-risk gastrointestinal endoscopic procedures
Title of the study (Brief title)	NOAC study
Region	Japan

Condition
Condition	All diseases that require high-risk gastrointestinal endoscopic procedures such as endoscopic polypectomy, endoscopic mucosal resection, endoscopic submucosal dissection, endoscopic balloon dilation, endoscopic mucosal ablation or percutaneous endoscopic gastrostomy
Classification by specialty	Gastroenterology Cardiology Neurology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To reveal the rate of bleeding or thromboembolism during the periendoscopic period when using non-vitamin K antagonist oral anticoagulants (NOAC) for antithrombotic therapy during the perioperative period of high-risk gastrointestinal endoscopic procedures
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Post-procedural bleeding rate (soon after registration to 2 months after endoscopic procedures, >= CTCAE v4.0 Grade 3)
Key secondary outcomes	1) Thromboembolism rate (soon after registration to 2 months after endoscopic procedures) 2) All complication rate (soon after registration to 2 months after endoscopic procedures) 3) Post-procedural bleeding rate (soon after registration to 2 months after endoscopic procedures, >= CTCAE v4.0 Grade 1) 4) Length of hospital stay

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	Replacement of warfarin by NOAC before endoscopic procedures
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) Taking warfarin or NOAC to prevent thromboembolism caused by non-valvular atrial fibrillation or recurrence of deep vein thrombus 2) 20 years old or older 3) Performance status (ECOG) of 0 to 2 4) Hb: >=9 g/dl 5) Plt: >=100000 /mm3 6) AST, ALT: <=150 U/l 7) eGFR: >=30 ml/min 8) Written informed consent
Key exclusion criteria	1) Clinical bleeding tendency 2) Allergy to NOAC 3) Azole antifungal drugs 4) Pregnant or lactation woman 5) Patients who are disqualified for the study by physicians
Target sample size	50

Research contact person
Name of lead principal investigator	Ryu Ishihara
Organization	Osaka International Cancer Institute
Division name	Department of Gastrointestinal Oncology
Address	3-1-69, Otemae, Chuo-ku, Osaka 541-8567, Japan
TEL	06-6945-1181
Email	isihara-ry@mc.pref.osaka.jp

Public contact
Name of contact person	Masamichi Arao
Organization	Osaka International Cancer Institute
Division name	Department of Gastrointestinal Oncology
Address	3-1-69, Otemae, Chuo-ku, Osaka 541-8567, Japan
TEL	06-6945-1181
Homepage URL
Email	arao-ma@mc.pref.osaka.jp

Sponsor
Institute	Osaka International Cancer Institute
Institute
Department

Funding Source
Organization	Osaka International Cancer Institute
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	No
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	大阪国際がんセンター(大阪府)

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 13 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 04 Month 17 Day
Anticipated trial start date	2015 Year 07 Month 13 Day
Last follow-up date	2018 Year 10 Month 13 Day
Date of closure to data entry	2018 Year 11 Month 30 Day
Date trial data considered complete	2018 Year 11 Month 30 Day
Date analysis concluded	2018 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	When patients taking warfarin undergo high-risk gastrointestinal endoscopic procedures, they need heparin replacement during the perioperative period. In these cases they need to use both of heparin and warfarin after procedures for 3 to 11 days, and very high rate of delayed bleeding has been reported. When patients take NOAC during the perioperative period, they don't need use heparin after endoscopic procedures, therefore decrease in delayed bleeding rate is expected.

Management information
Registered date	2015 Year 07 Month 13 Day
Last modified on	2017 Year 06 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021156