UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024181 |
|---|---|
| Receipt number | 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 14:32:16 |
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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
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
ys13544@kchnet.or.jp
Sponsor or person
Institute
Kurashiki Central Hospital
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
