UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035358 |
|---|---|
| Receipt number | R000031342 |
| Scientific Title | Prevalence of Upper Gastrointestinal Bleeding in Antithrombotic Agent Treatment: Wakayama UGB Registry |
| Date of disclosure of the study information | 2019/01/01 |
| Last modified on | 2025/06/30 11:39:16 |
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Basic information
Public title
Prevalence of Upper Gastrointestinal Bleeding in Antithrombotic Agent Treatment: Wakayama UGB Registry
Acronym
Prevalence of Upper Gastrointestinal Bleeding in Antithrombotic Agent Treatment
Scientific Title
Prevalence of Upper Gastrointestinal Bleeding in Antithrombotic Agent Treatment: Wakayama UGB Registry
Scientific Title:Acronym
Prevalence of Upper Gastrointestinal Bleeding in Antithrombotic Agent Treatment
Region
| Japan |
Condition
Condition
Upper Gastrointestinal Bleeding
Classification by specialty
| Hepato-biliary-pancreatic medicine | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Survey of upper gastrointestinal bleeding in antithrombotic agent treatment
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Upper Gastrointestinal Bleeding
Key secondary outcomes
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
Patients contined antithrombotic agent treatment for three months. This study was written informed consent was obtained from all patients.
Key exclusion criteria
Patients have been already done for upper endoscopy within three months.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | takashi |
| Middle name | |
| Last name | yamano |
Organization
Wakayama medical university
Division name
Department of cardiovascular medicine
Zip code
641-0012
Address
811-1 Kimiidera, Wakayama City, Japan
TEL
0734772300
ymntks@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | takashi |
| Middle name | |
| Last name | yamano |
Organization
Wakayama medical university
Division name
Department of cardiovascular medicine
Zip code
641-0012
Address
811-1 Kimiidera, Wakayama City, Japan
TEL
0734772300
Homepage URL
ymntks@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama medical university
Institute
Department
Personal name
Funding Source
Organization
Wakayama medical university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Wakayama medical university
Address
811-1 Kimiidera, Wakayama City, Japan
Tel
0734772300
ymntks@wakayama-med.ac.jp
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
| 2019 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.wakayama-med.ac.jp/info/rinshoukenkyu/index.html
Publication of results
Unpublished
Result
URL related to results and publications
https://www.wakayama-med.ac.jp/info/rinshoukenkyu/index.html
Number of participants that the trial has enrolled
298
Results
The proportion of anticoagulant therapy was as follows: aspirin alone in 88 cases, dual antiplatelet therapy with two agents in 32 cases, warfarin alone in 89 cases, 45 casesof anticoagulant therapy other than warfarin, and 44 casesof combined antiplatelet and anticoagulant therapy. Multivariate logistic regression analysis revealed that age, excessive alcohol consumption, history of myocardial infarction, history of cerebrovascular infarction, and BNP were independent risk factors for IB.
Results date posted
| 2025 | Year | 06 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Gastrointestinal bleeding (IB) is a serious life-threatening problem for cardiovascular disease (CVD) patients receiving antithrombotic therapy. However, Helicobacter pylori (HP) infection is recognized as an important risk factor for GI bleeding, but the prevalence of HP infection has decreased, and HP eradication therapy has become widely available. Therefore, we established the Wakayama GI Bleeding Registry and conducted a prospective, comprehensive registration of CVD patients receiving anticoagulant therapy to investigate the current status and risk factors for GI blee
Participant flow
After obtaining informed consent, 298 asymptomatic CVD patients receiving stable antiplatelet therapy or anticoagulant therapy were enrolled. Blood samples were collected from all patients at baseline and at 3 months of follow-up, and anti-HP antibodies were measured. Cases with a decrease in Hb of 2 mg/dl or more at 3 months were defined as IB if there were no other causes of bleeding, and endoscopy was performed to identify the source of bleeding.
Adverse events
none
Outcome measures
gastrointestinal bleeding
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 01 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 01 | Month | 30 | Day |
Other
Other related information
We investigated the current status and remained risk factors for intestinal bleeding in patients with antiplatelet therapy or anticoagulant therapy .
Management information
Registered date
| 2018 | Year | 12 | Month | 25 | Day |
Last modified on
| 2025 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031342
