UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009176
Receipt number R000010700
Scientific Title Safety evaluation of high-risk endoscopic procedures on aspirin for high-risk patients of thromboembolism.
Date of disclosure of the study information 2012/10/23
Last modified on 2014/03/09 12:30:57

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Basic information

Public title

Safety evaluation of high-risk endoscopic procedures on aspirin for high-risk patients of thromboembolism.

Acronym

STRAP study (Safe endoscopic TReatment on Anti Platelet agent study)

Scientific Title

Safety evaluation of high-risk endoscopic procedures on aspirin for high-risk patients of thromboembolism.

Scientific Title:Acronym

STRAP study (Safe endoscopic TReatment on Anti Platelet agent study)

Region

Japan


Condition

Condition

Status requiring high-risk procedures in gastrointestinal tract during anti-platelet therapy.

Classification by specialty

Medicine in general Gastroenterology Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate safety of high-risk procedures on aspirin for high-risk patients of thromboembolism.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Complication rate (bleeding and thromboembolism).

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Endoscopic polypectomy
Endoscopic mucosal resection
Endoscopic submucosal dissection
Endoscopic variceal ligation
Endoscopic injection sclerotherapy
Endoscopic dilatation
Endoscopic mucosal ablation

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

(A)Medical need of high-risk endoscopic procedures.
(B)Comorbidity requiring antiplatelet therapy.
(C)Receiving antiplatelet agents.
(D)Informed consent.
(E)Performance status(ECOG):0-2.
(F)Scheduled blood test 14 days after procedures.

Key exclusion criteria

(A)Receiving anticoagulants.
(B)Severe hematological, hepatological, or renal disorder accompanied with hemorrhagic tendency.
(C)Other severe comorbidities.
(D)During anticancer chemotherapy.
(E)Poor compliance.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Satoshi Ono

Organization

The University of Tokyo

Division name

Department of gastroenterology

Zip code


Address

7-3-1, Hongo, Bunkyo, Tokyo.

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

The University of Tokyo

Division name

Department of gastroenterology

Zip code


Address

7-3-1, Hongo, Bunkyo, Tokyo.

TEL


Homepage URL


Email



Sponsor or person

Institute

Department of gastroenterology, The University of Tokyo.

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

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

2012 Year 10 Month 23 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

Terminated

Date of protocol fixation

2012 Year 07 Month 04 Day

Date of IRB


Anticipated trial start date

2012 Year 10 Month 23 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

2012 Year 10 Month 23 Day

Last modified on

2014 Year 03 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010700


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name