UMIN-CTR Clinical Trial

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