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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018946
Receipt No. R000021916
Scientific Title Exploration into the lipid management and persistent risk in the patients hospitalized for acute coronary syndrome in Japan
Date of disclosure of the study information 2015/10/02
Last modified on 2018/10/16

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Basic information
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
Condition Acute Coronary Syndrome (ACS)
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information YES

Objectives
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

Assessment
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

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
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

Research contact person
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

Public contact
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

Sponsor
Institute Sanofi K.K.
Institute
Department

Funding Source
Organization Sanofi K.K.
Organization
Division
Category of Funding Organization Profit organization
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
2015 Year 10 Month 02 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 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
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

Management information
Registered date
2015 Year 09 Month 08 Day
Last modified on
2018 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021916

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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