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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025181
Receipt No. 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 2016/12/07

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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
Email 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
Email kuramitsu@circulation.jp

Sponsor
Institute Kokura Memorial Hospital
Institute
Department

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
Email

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 Enrolling by invitation
Date of protocol fixation
2016 Year 11 Month 17 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 13 Day
Last follow-up date
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
2016 Year 12 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028968

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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