UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024576 |
|---|---|
| Receipt number | 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 11:18:08 |
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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
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
fujii@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028282
