UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049264 |
|---|---|
| Receipt number | R000056105 |
| Scientific Title | An Exploratory Study of Atherosclerosis/Bleeding Risk Events in Patients Undergoing Percutaneous Coronary Intervention |
| Date of disclosure of the study information | 2022/10/19 |
| Last modified on | 2024/11/07 10:29:25 |
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Basic information
Public title
An Exploratory Study of Atherosclerosis/Bleeding Risk Events in Patients Undergoing Percutaneous Coronary Intervention
Acronym
Exploratory Study on Post-PCI Atherosclerosis/Bleeding Risk and Events
Scientific Title
An Exploratory Study of Atherosclerosis/Bleeding Risk Events in Patients Undergoing Percutaneous Coronary Intervention
Scientific Title:Acronym
Exploratory Study on Post-PCI Atherosclerosis/Bleeding Risk and Events
Region
| Japan |
Condition
Condition
Ischemic heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assess atherosclerosis/bleeding risk in patients undergoing PCI.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cardiovascular bleeding composite endpoint (total death + nonfatal myocardial infarction + angina requiring revascularization + stent thrombosis + stroke + major bleeding event (BARC 3 or 5))
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 undergoing PCI
Key exclusion criteria
If you refuse to participate in the research
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | KEISUKE |
| Middle name | |
| Last name | KOJIMA |
Organization
Nihon University School of Medicine
Division name
Department of Cardiology
Zip code
173-8610
Address
Tokyo, Itabashi, Oyaguchi-kamimachi 30-1
TEL
03-3972-8111
kojima.keisuke@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | KEISUKE |
| Middle name | |
| Last name | KOJIMA |
Organization
Nihon University Itabashi Hospital
Division name
Department of Cardiology
Zip code
173-8610
Address
Tokyo, Itabashi, Oyaguchi-kamimachi 30-1
TEL
03-3972-8111
Homepage URL
kojima.keisuke@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine
Department of Cardiology
Institute
Department
Personal name
Funding Source
Organization
Nihon University School of Medicine
Department of Cardiology
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
Center for Clinical Research, Nihon University Itabashi Hospital
Address
Tokyo, Itabashi, Oyaguchi-kamimachi 30-1
Tel
03-3972-8111
med.itabashi.chiken@nihon-u.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
| 2022 | Year | 10 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 09 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study aims to clarify the relationship between the potential risk of atherosclerosis (subcutaneous and visceral fat, vascular disease, nonalcoholic fatty liver disease, constipation, etc.) and bleeding risk (anemia, hemorrhage in systemic organs) and future atherosclerosis (myocardial infarction, stroke, etc.) and bleeding events in patients with CAD. (myocardial infarction, stroke, etc.) and bleeding events in the future, and to identify novel risks and therapeutic interventions necessary to improve the prognosis of post-revascularization CAD patients in a prospective registry conducted within an insured setting. The objective of this study is to identify novel risks and therapeutic interventions necessary to improve the life expectancy of patients with CAD after revascularization. In Japan, where the incidence of cardiac disease is rapidly increasing due to the aging of the population, early detection and intervention of other atherosclerosis and bleeding risks, in addition to the current medical treatment and revascularization, will contribute to the extension of healthy life expectancy.
Management information
Registered date
| 2022 | Year | 10 | Month | 19 | Day |
Last modified on
| 2024 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056105
