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
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
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
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
