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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000018284
Receipt No. 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

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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
Email 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
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)

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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021156

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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