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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000009176
Receipt No. 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

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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
Institute Department of gastroenterology, The University of Tokyo.
Institute
Department

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
URL(English) https://upload.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


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