UMIN-CTR Clinical Trial

Public title

Exploration into the lipid management and persistent risk in the patients hospitalized for acute coronary syndrome in Japan

Acronym

Exploration into the lipid management and persistent risk in the patients hospitalized for acute coronary syndrome (EXPLORE-J)

Scientific Title

Exploration into the lipid management and persistent risk in the patients hospitalized for acute coronary syndrome in Japan

Scientific Title:Acronym

Exploration into the lipid management and persistent risk in the patients hospitalized for acute coronary syndrome (EXPLORE-J)

Region

Japan

Condition

Acute Coronary Syndrome (ACS)

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

To assess the current lipid management of patients hospitalized for ACS, and their persistent CV risk despite undergoing current standard therapy

Basic objectives2

Others

Basic objectives -Others

1.To identify the percentage of patients reaching current lipid targets
2.To compare the incidence of MACE between the patients by LDL-C level
3.To determine the prevalence of FH, including both HeFH and HoFH, among patients hospitalized for ACS

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

The persistent risk will be defined as the incidence of major adverse cardiovascular events (MACE)

Key secondary outcomes

[1] Coronary revascularization based on myocardial ischemia#2
[2] Revascularization excluding the heart
[3] Inpatient treatment due to occurrence or exacerbation of heart failure
[4] Transient ischemic attack (TIA)#3
[5] Acute arterial obstruction
[6] Central retinal artery occlusion
[7] Other adverse events prolonging or requiring hospitalization

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1)Patients hospitalized for any ACS (Acute ST-segment elevation myocardial infarction: STEMI, Acute non ST-segment elevation myocardial infarction: NSTEMI, Unstable angina :UA)
2)Patients aged equal or over 20 years
3)Written informed consent

Key exclusion criteria

1) ACS accompanied by or precipitated by significant comorbidity.

2) Enrolled other lipid interventional studies

3) Patients with sub-acute stent-thrombosis caused by revascularization procedures.

Target sample size

2000

Name of lead principal investigator

1st name
Middle name
Last name	Masato Nakamura

Organization

Toho University Ohashi Medical Center

Division name

Cardiovascular Medicine

Zip code

Address

2-17-6 Ohashi Meguro-ku, Tokyo

TEL

03-3468-1251

Email

explore-j@mebix.co.jp

Name of contact person

1st name
Middle name
Last name	Hiroichi Yamamoto

Organization

Mebix

Division name

EXPLORE-J office

Zip code

Address

3-9-21, Toranomon, Minato-ku, Tokyo

TEL

03-4362-4504

Homepage URL

Email

explore-j@mebix.co.jp

Institute

Sanofi K.K.

Institute

Department

Personal name

Organization

Sanofi K.K.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

10

Month

02

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

No longer recruiting

Date of protocol fixation

2015

Year

01

Month

23

Day

Date of IRB

Anticipated trial start date

2015

Year

04

Month

21

Day

Last follow-up date

2018

Year

09

Month

20

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Study Design:
Nation-wide, Multi-centre, Prospective Observational study

Patient selection:
Hospitalized, from April 2015 to March 2016, ACS patients in prespecified hospitals

Data collected:
At baseline
-Demography
-Family history
-Physical examination
-Achilles tendon thickness
-Medication and Medical histories
-Diagnosis of FH by physicians
-DNA (for specifically consented patients only)

At baseline and the follow-up timing (Day1, 30, 180, 1yr and 2yr)
-MACE
-Laboratory measurements: LDL-C, HDL-C, Triglycerides, non-HDLC, apoA1, apoB, Lp(a), hs-CRP and PCSK9

Registered date

2015

Year

09

Month

08

Day

Last modified on

2018

Year

10

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021916