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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000004937
Receipt No. R000005829
Scientific Title Assessment of antithrombic agents for endoscopic procedure using biopsy forceps
Date of disclosure of the study information 2011/02/01
Last modified on 2014/07/25

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Basic information
Public title Assessment of antithrombic agents for endoscopic procedure using biopsy forceps
Acronym ASAMA-study
Scientific Title Assessment of antithrombic agents for endoscopic procedure using biopsy forceps
Scientific Title:Acronym ASAMA-study
Region
Japan

Condition
Condition patients on anti-thrombotic therapy who need gastrointestinal endoscopy procedure using biopsy forceps.
Classification by specialty
Medicine in general Gastroenterology Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to evaluate the risk of bleeding in endoscopic procedures using biopsy forceps while taking antithrombotic agents (warfarin, aspirin, thienopyridine derivatives) .
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1)the prevalence and severity of gastric bleeding during gastric biopsy, and the prevalence of gastric breeding which requires hemostatic therapy.

2)The prevalence and severity of postoperative gastric bleedig after gastric biopsy, and the prevalence of the breeding which requires hemostatic therapy.
Key secondary outcomes 1)the prevalence and severity of thromboembolic events.

Base
Study type Interventional

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

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 group A:to perform gastric biopsy while continuing antithrombotic agents(warfarin, aspirin, thienopyridine derivatives).
Interventions/Control_2 group B:to perform gastric biopsy under discontinuation of antithrombotic agents according to the reccomendation of the Japanese guideline for endoscopic procedures(Japan gastroenterogical endoscopy society).
Interventions/Control_3 group C(control):to perform usual gastric biopsy to the patients without taking any antithrombotic agents.
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 adult patients who need gastrointestinal endoscopy, and may require endoscopic procedures using biopsy forceps.
Key exclusion criteria 1)without agreement
2)PT-INR>3.0 in warfarin taking patients(within 1 Month before procudere)
3)taking dual antiplatelet therapy(both aspirin and thienopyridine delivatives)(patients under discontinuation of thienopyridine delivatives before biopsy procedure can be enrolled).
4)receiving both anticoagulant and antiplatelet therapy(patients with discontinuation of antiplatelet agents or warfarin before biopsy procedure can be enrolled).
5)taking antiplatelet agents other than aspirin or thienopyridine derivatives.
6)within 12months after drug eluting stent placement.
7)taking warfarin for DVT.
8)other serious conditions, pregnency, overt bleeding tendency.
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Uichi Ikeda
Organization Shinshu University School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 3-1-1 Asahi, Matsumoto, Japan
TEL 0263-37-3486
Email uikeda@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Kasai
Organization Shinshu University School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 3-1-1 Asahi, Matsumoto, Japan
TEL 0263-37-3486
Homepage URL
Email hkasai@shinshu-u.ac.jp

Sponsor
Institute Shinshu University School of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
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
2011 Year 02 Month 01 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 Preinitiation
Date of protocol fixation
2011 Year 01 Month 11 Day
Date of IRB
Anticipated trial start date
2011 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 01 Month 24 Day
Last modified on
2014 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005829

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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