UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018284 |
|---|---|
| Receipt number | R000021156 |
| Scientific Title | A study to assess the safety of non-vitamin K antagonist oral anticoagulants on high-risk gastrointestinal endoscopic procedures |
| Date of disclosure of the study information | 2015/07/13 |
| Last modified on | 2017/06/01 15:36:57 |
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Basic information
Public title
A study to assess the safety of non-vitamin K antagonist oral anticoagulants on high-risk gastrointestinal endoscopic procedures
Acronym
NOAC study
Scientific Title
A study to assess the safety of non-vitamin K antagonist oral anticoagulants on high-risk gastrointestinal endoscopic procedures
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Ryu Ishihara |
Organization
Osaka International Cancer Institute
Division name
Department of Gastrointestinal Oncology
Zip code
Address
3-1-69, Otemae, Chuo-ku, Osaka 541-8567, Japan
TEL
06-6945-1181
isihara-ry@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masamichi Arao |
Organization
Osaka International Cancer Institute
Division name
Department of Gastrointestinal Oncology
Zip code
Address
3-1-69, Otemae, Chuo-ku, Osaka 541-8567, Japan
TEL
06-6945-1181
Homepage URL
arao-ma@mc.pref.osaka.jp
Sponsor or person
Institute
Osaka International Cancer Institute
Institute
Department
Personal name
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)
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
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 |
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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 04 | Month | 17 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021156
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
