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

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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

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

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

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 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

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name