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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000024181
Receipt No. R000027838
Scientific Title Safety of colorectal polypectomy with switching warfarin to direct oral anticoagulant
Date of disclosure of the study information 2016/09/27
Last modified on 2019/12/27

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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