UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004937 |
|---|---|
| Receipt number | 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 07:27:01 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
hkasai@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005829
