UMIN-CTR Clinical Trial

Basic information
Public title	Safety of colorectal polypectomy with switching warfarin to direct oral anticoagulant
Acronym	SWARD trial
Scientific Title	Safety of colorectal polypectomy with switching warfarin to direct oral anticoagulant
Scientific Title:Acronym	SWARD trial
Region	Japan

Condition
Condition	Colorectal polyp
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the safety of colorectal polypectomy with switching warfarin to direct oral anticoagulant (DOAC)
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase II,III

Assessment
Primary outcomes	Incidence of delayed bleeding and thromboembolic event
Key secondary outcomes	Incidence of immediate bleeding and perforation, hospitalization

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Colorectal polypectomy with switching warfarin to DOAC
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	Subjects must satisfy all of the following criteria to be enrolled in the study 1.Age:over 20 years-old and under 90 years-old 2.concomitant use of warfarin 3.Colorectal polyps available to be resected by EMR or polypectomy 4.Cardiologist permitted switching warfarin to DOAC(patient with nonvalvular atrial fibrillation or deep vein thrombosis or pulmonary vein thrombosis, without severe renal failure: CCr >30ml/min, without any other contraindication to DOAC) 5.Written informed consent to continue DOAC after this study was obtained 6.Discontinuation or switching to aspirin/cilostazol is available in case of taking thienopyridine derivative 7.Written informed consent for this study was obtained
Key exclusion criteria	Potential subjects who meet any of the following criteria will be excluded from participating in the study 1.pregnant or breast-feeding 2.patient with inflammatory bowel disease or familial polyposis 3.without bleeding tendency(Platelet count <90,000/uL at the screening visit) 4.poor bowel preparation
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yuichi Shimodate
Organization	Kurashiki Central Hospital
Division name	Gastroenterology and Hepatology
Zip code
Address	1-1-1, Miwa, Kurashiki, Okayama
TEL	086-422-0210
Email	ys13544@kchnet.or.jp

Public contact
Name of contact person	1st name Middle name Last name Yuichi Shimodate
Organization	Kurashiki Central Hospital
Division name	Gastroenterology and Hepatology
Zip code
Address	1-1-1, Miwa, Kurashiki, Okayama
TEL	086-422-0210
Homepage URL
Email	ys13544@kchnet.or.jp

Sponsor
Institute	Kurashiki Central Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 09 Month 27 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	2016 Year 09 Month 20 Day
Date of IRB	2019 Year 12 Month 23 Day
Anticipated trial start date	2016 Year 10 Month 20 Day
Last follow-up date	2019 Year 12 Month 23 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 09 Month 27 Day
Last modified on	2019 Year 12 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027838