UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000024576
Receipt No. R000028282
Scientific Title Transradial Intervention for Acute Coronary Syndrome -J-PCI Registry-
Date of disclosure of the study information 2016/11/01
Last modified on 2020/04/29 (Ver. 6)

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Basic information
Public title Transradial Intervention for Acute Coronary Syndrome -J-PCI Registry-
Acronym TRIACS-J
Scientific Title Transradial Intervention for Acute Coronary Syndrome -J-PCI Registry-
Scientific Title:Acronym TRIACS-J
Region
Japan

Condition
Condition Acute coronary syndrome
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify mortality reduction by transradial coronary intervention (TRI) for patients with acute coronary syndrome (ACS) compared with transfemoral approach
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes a composite of in-hospital death, MI associated with PCI, bleeding complication requiring transfusion, and stent thrombosis during in-hospital stay.
Key secondary outcomes Bleeding complications
In hospital mortality

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
19 years-old <
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Acute coronary syndrome treated by percutaneous coronary intervention
Key exclusion criteria None
Target sample size 80000

Research contact person
Name of lead principal investigator
1st name Yuji
Middle name
Last name Ikari
Organization Tokai University
Division name Cardiology
Zip code 259-1193
Address 143 Shimokasuya, Isehara, Kanagawa 259-1193
TEL 0463-93-1121
Email ikari@is.icc.u-tokai.ac.jp

Public contact
Name of contact person
1st name Toshiharu
Middle name
Last name Fujii
Organization Tokai University
Division name Cardiolgoy
Zip code 259-1193
Address 143 Shimokasuya, Isehara, Kanagawa 259-1193
TEL 0463-93-1121
Homepage URL
Email fujii@is.icc.u-tokai.ac.jp

Sponsor
Institute Tokai University
Institute
Department

Funding Source
Organization Tokai 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 Tokai University
Address 143 Shimokasuya Isehara 259-1193 Japan
Tel 0463-93-1121
Email kenkyu@tokai-u.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 All institutions in Japan registering data to J-PCI registry

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 01 Day

Related information
URL releasing protocol Cardiovasc Interv Ther. 2019 Oct;34(4):297-304. doi: 10.1007/s12928-019-00582-0. Epub 2019 Mar 7.
Publication of results Published

Result
URL related to results and publications Cardiovasc Interv Ther. 2019 Oct;34(4):297-304. doi: 10.1007/s12928-019-00582-0. Epub 2019 Mar 7.
Number of participants that the trial has enrolled 76835
Results 
Propensity score matching (PS) and instrumental variable (IV) analyses were used to account for treatment selection. The incidence of post-treatment adverse events was lower in the TRI group by 0.95% compared to the TFI group with PS (p < 0.001) and by 0.34% with IV (p = 0.127). A significantly lower risk for access site bleeding was observed by 0.34% with PS (p < 0.001) and by 0.53% with IV (p < 0.001).
Results date posted
2020 Year 04 Month 29 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
We retrospectively analyzed a large nation-wide registry in Japan to compare the incidence of post-treatment adverse events according to the types of vessel access (trans-radial; TRI vs. trans-femoral; TFI) among ACS cases (n = 76,835; 43,288 TRI group and 33,547 TFI group).
Participant flow 
Nation-wide registry data in Japan
Adverse events 
No adverse events due to retrospective analyses
Outcome measures 
Primary outcome was a composite of in-hospital death, myocardial infarction associated with percutaneous coronary intervention, bleeding complication requiring transfusion, and stent thrombosis during in-hospital stay.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 01 Month 01 Day
Date of IRB
2014 Year 01 Month 01 Day
Anticipated trial start date
2014 Year 01 Month 01 Day
Last follow-up date
2014 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is a retrospective study using J-PCI registry which is a national database of PCI in Japan. In Japan, there is no IIbIIIa inhibitors due to no govermental approval. In ACS, all are unfractioned heparin and DAPT with clopidogrel. Under the constant angicoagulation therapy, benefits of TRI is compared with transfemoral approach.

Management information
Registered date
2016 Year 10 Month 26 Day
Last modified on
2020 Year 04 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028282