UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041849 |
|---|---|
| Receipt number | R000047773 |
| Scientific Title | Multicenter observational study of real-world efficacy and safety of antithrombotic therapy underwent percutaneous coronary intervention (PCI) |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2024/11/07 10:32:57 |
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Basic information
Public title
Multicenter observational study of real-world efficacy and safety of antithrombotic therapy underwent percutaneous coronary intervention (PCI)
Acronym
Multicenter observational study of efficacy and safety of antithrombotic therapy underwent percutaneous coronary intervention (PCI)
Scientific Title
Multicenter observational study of real-world efficacy and safety of antithrombotic therapy underwent percutaneous coronary intervention (PCI)
Scientific Title:Acronym
Multicenter observational study of efficacy and safety of antithrombotic therapy underwent percutaneous coronary intervention (PCI)
Region
| Japan |
Condition
Condition
Ischemic heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is aimed to investigate Post-PCI real-world antithrombotic period and prognosis by period.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Major adverse cardiac or cerebrovascuar events: all cause death, non-fatal myocardial infarct, stent thrombosis, revascularization, stroke
Key secondary outcomes
Major and minor bleeding event
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 those who have obtained the informed consent of the research subject
Key exclusion criteria
Patients with contraindications to antithrombotic therapy, Pregnant women, lactating women, women who may be pregnant
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Riku |
| Middle name | |
| Last name | Arai |
Organization
Nihon University School of Medicine
Division name
Division of Cardiology, Department of Internal Medicine
Zip code
173-8610
Address
30-1, Oyaguchikami-cho, Itabashi-ku, Tokyo
TEL
03-3972-8111
arai.riku@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Riku |
| Middle name | |
| Last name | Arai |
Organization
Nihon University School of Medicine
Division name
Division of Cardiology, Department of Internal Medicine
Zip code
173-8610
Address
30-1, Oyaguchikami-cho, Itabashi-ku, Tokyo
TEL
03-3972-8111
Homepage URL
arai.riku@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nihon University School of Medicine
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
Nihon University Itabashi Hospital, Clinical Research Judging Committee
Address
30-1, Oyaguchikami-cho, Itabashi-ku, Tokyo
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
| 2020 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
1182
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The administration period of antiplatelet drugs including DAPT in patients with ischemic heart disease emphasizes bleeding complications and tends to be significantly shortened even in Japanese guidelines. Against this background of the times, it is estimated that the administration period of antiplatelet drugs will be shortened rapidly even in clinical practice, and it can be said that the accumulation of evidence in clinical practice of antiplatelet drugs is an urgent issue.
Management information
Registered date
| 2020 | Year | 09 | 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=R000047773
