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

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 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


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

Value
https://center6.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