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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000039768
Receipt No. 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

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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
Email 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
Email ttakura@m.u-tokyo.ac.jp

Sponsor
Institute The University of Tokyo
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044821

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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