UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039768 |
|---|---|
| Receipt number | R000044821 |
| Scientific Title | Clinical Outcome and Cost-effectiveness of Routine Follow-up Coronary Angiography after Percutaneous Coronary stenting in Japan |
| Date of disclosure of the study information | 2020/03/12 |
| Last modified on | 2020/05/06 13:15:37 |
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Basic information
Public title
Clinical Outcome and Cost-effectiveness of Routine Follow-up Coronary Angiography after Percutaneous Coronary stenting in Japan
Acronym
Cost-effectiveness of Routine Follow-up Coronary Angiography after Percutaneous Coronary stenting
Scientific Title
Clinical Outcome and Cost-effectiveness of Routine Follow-up Coronary Angiography after Percutaneous Coronary stenting in Japan
Scientific Title:Acronym
Cost-effectiveness of Routine Follow-up Coronary Angiography after Percutaneous Coronary stenting
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate clinical economic indicators of routine follow-up coronary angiography after percutaneous coronary stenting from a social perspective on health insurance.
Basic objectives2
Others
Basic objectives -Others
Effectiveness, Incremental cost
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary endpoint was the 3-year cumulative incidence of major adverse cardiac events and the cumulative cost based on direct medical costs.
Key secondary outcomes
Secondary endpoints included all-cause death, nonfatal myocardial infarction, urgent revascularization, coronary artery bypass grafting, stroke, hospitalization for heart failure, and any coronary revascularization.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing coronary artery stenting
Key exclusion criteria
Previous CABG within 1 year before Index PCI, concurrent end-stage renal failure on dialysis or cancer treated with surgery or chemotherapy during enrollment and follow-up.
Target sample size
856
Research contact person
Name of lead principal investigator
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Takura |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Healthcare Economics and Health Policy
Zip code
113-8655
Address
7-3-1 Hongo,Bunkyo-ku,Tokyo
TEL
03-5800-9523
ttakura@m.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Takura |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Healthcare Economics and Health Policy
Zip code
113-8655
Address
7-3-1 Hongo,Bunkyo-ku,Tokyo
TEL
03-5800-9523
Homepage URL
ttakura@m.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
The University of Tokyo
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
Tokyo University of Tokyo Hospital
Address
7-3-1 Hongo,Bunkyo-ku,Tokyo
Tel
03-5800-9523
hehp-labo@umin.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 | 03 | Month | 12 | 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
558
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
| 2018 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data base research
Management information
Registered date
| 2020 | Year | 03 | Month | 11 | Day |
Last modified on
| 2020 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044821
