UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009109 |
|---|---|
| Receipt number | R000010682 |
| Scientific Title | GI endoscopy and anticoagulant therapy -a multicenter obsevational study- |
| Date of disclosure of the study information | 2012/10/15 |
| Last modified on | 2018/08/31 09:50:30 |
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Basic information
Public title
GI endoscopy and anticoagulant therapy -a multicenter obsevational study-
Acronym
Osaka GI-anticoagulant (GIANT) study
Scientific Title
GI endoscopy and anticoagulant therapy -a multicenter obsevational study-
Scientific Title:Acronym
Osaka GI-anticoagulant (GIANT) study
Region
| Japan |
Condition
Condition
Patients who are treated with anticoagulant drugs requiring endoscopic biopsy or therapeutics
Classification by specialty
| Medicine in general | Gastroenterology | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the prevalence of GI bleeding after endoscopy or treatents in patients treated with anticoagulants.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Prevalence of GI bleeding within one month after the endoscopy or endoscopic treatment
Key secondary outcomes
1. Duration of hospitalization
2. Prevalence of cardiovascular and cerebro- and systemic vascular events after endoscopy or endoscopic treatment
3. Frequency of requiring re-endoscopy
4. Frequency of massive GI bleeding
5. Frequency of massive GI bleeding threatening life
6. Frequency of cerebrovascular bleeding
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients taking warfarin or other antigocoagulant drugs (e.g., dabigatran).
2) Patients older than 20 years old.
3) Patients requiring endoscopic biopsy or treatment
4) Patients who gave written informed concent.
Key exclusion criteria
1) Patients with unstable vital sign with high risk of endoscopy.
2) Patients with apparent GI bleeding before endoscopy.
3)Pregnant, breast-feeding women and possibility of pregnancy
4)Patients who will perform endoscopic biopsy and treatment during the same hospitalization period
5)Patients who were considered not suitable to be included in this study by the physician.
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuo Takehara |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL
06-6879-3621
takehara@gh.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Iijima |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL
06-6879-3621
Homepage URL
hiijima@gh.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
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
| 2012 | Year | 10 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
DOAC administration showed similar post-procedural GI bleeding risk to VKA administration in patients undergoing endoscopic procedures, but it shortened the hospital stay.
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
Completed
Date of protocol fixation
| 2012 | Year | 09 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 06 | Month | 19 | Day |
Date trial data considered complete
| 2016 | Year | 06 | Month | 19 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 01 | Day |
Other
Other related information
Patients taking anticoagulants and requiring endoscopic biopsy or treatment will be prospectively registered and will be assessed for the risk of GI bleeding and cerebrovascular events.
Management information
Registered date
| 2012 | Year | 10 | Month | 13 | Day |
Last modified on
| 2018 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010682
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
