UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025181 |
|---|---|
| Receipt number | R000028968 |
| Scientific Title | Retrospective Multicenter Registry of Stent Thrombosis After First- and Second-Generation Drug-Eluting Stents Implantation |
| Date of disclosure of the study information | 2016/12/13 |
| Last modified on | 2019/10/08 14:28:48 |
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Basic information
Public title
Retrospective Multicenter Registry of Stent Thrombosis After First- and Second-Generation Drug-Eluting Stents Implantation
Acronym
REAL-ST
Scientific Title
Retrospective Multicenter Registry of Stent Thrombosis After First- and Second-Generation Drug-Eluting Stents Implantation
Scientific Title:Acronym
REAL-ST
Region
| Japan |
Condition
Condition
coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We sought to (1) compare the baseline clinical characteristics and clinical outcome in patients with stent thrombosis (ST) after second-generation drug-eluting stents (DES) implantation compared with those without any ST (control group); (2) assess the risk factors of each ST after second-generation DES implantation.
Basic objectives2
Others
Basic objectives -Others
We sought to compare baseline clinical characteristics, risk factors, and clinical outcome between patients with ST after first- and second-generation DES implantation.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We sought to assess the baseline clinical characteristics, risk factors of each ST, and 1-year clinical outcome in patients with early-, late-, and very late ST after second-generation DES implantation compared with those without any ST (control group).
Key secondary outcomes
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
1) Patients with definite stent thrombosis (ST) after first- or second-generation DES implantation
2) As a control group, 4 patients without any ST in whom second-generation DES was implanted are selected for one patient with ST after second-generation DES in each participating institution.
Key exclusion criteria
Patients with cardiopulmonary arrest on arrival at index PCI
Target sample size
1300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shoichi Kuramitsu |
Organization
Kokura Memorial Hospital
Division name
Cardiology
Zip code
Address
3-2-1 Asano, Kokurakita-ku, Kitakyushu, Fukuoka
TEL
093-511-2000
kuramitsu@circulation.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shoichi Kuramitsu |
Organization
Kokura Memorial Hospital
Division name
Cardiology
Zip code
Address
3-2-1 Asano, Kokurakita-ku, Kitakyushu, Fukuoka
TEL
093-511-2000
Homepage URL
kuramitsu@circulation.jp
Sponsor or person
Institute
Kokura Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
Kokura Memorial Hospital
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
Address
Tel
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
| 2016 | Year | 12 | Month | 13 | 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
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
Main results already published
Date of protocol fixation
| 2016 | Year | 11 | Month | 17 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 13 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We retrospectively enroll the patients with definite stent thrombosis after first- and second-generation DES implantation in Japanese multicenters from April 2004 to December 2015. We sought to assess the baseline clinical characteristics, risk factors of each ST, and 1-year clinical outcome in patients with early-, late-, and very late ST after second-generation DES compared with those without any ST (control group). In addition, we sought to compare baseline clinical characteristics, risk factors, and clinical outcome between patients with ST after first- and second-generation DES.
Management information
Registered date
| 2016 | Year | 12 | Month | 07 | Day |
Last modified on
| 2019 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028968
