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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000034434
Receipt No. R000034587
Scientific Title Impact of Pemafibrate on coronary plaque characteristics in ACS patients
Date of disclosure of the study information 2018/10/10
Last modified on 2019/04/08

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Basic information
Public title Impact of Pemafibrate on coronary plaque characteristics in ACS patients
Acronym Pemafibrate and coronary plaque characteristics
Scientific Title Impact of Pemafibrate on coronary plaque characteristics in ACS patients
Scientific Title:Acronym Pemafibrate and coronary plaque characteristics
Region
Japan

Condition
Condition ACS patients who underwent OCT guided PCI
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify impact of pemafibrate on coronary artery plaque characteristics in ACS patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Plaque characteristics by OCT
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Pemafibrate
Interventions/Control_2 Standard therapy
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
90 years-old >=
Gender Male and Female
Key inclusion criteria 1. ACS(STEMI or NSTEMI/Unstable angina)
2. Presence of coronary artery plaque more than 5 mm from the target lesion for PCI
3. TG>150mg/dl
4. Age > 20yo
5. Written informed consent obtained

Key exclusion criteria 1. SVG or in-stent restenosis lesion
2. Previous history of PCI to the target lesion
3. Vessel with diffuse coronary artery stenosis which is scheduled for PCI
4. Cardiogenic shock
5. Allergy to the study drug (Pemafibrate)
6. Severe lever injury or biliary tract obstruction
7. Moderate to severe renal dysfunction(SCr >2.5mg/dl)
8. Presence of bile stone
9. pregnant or lactating woman
10. Use of Cyclosporine or Rifampicin
11. Insulin requiring diabetes\
12. Those who are considered as unsuitable candidate by investigators
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsunenari Soeda
Organization Nara Medical University
Division name Cardiovascular Medicine
Zip code
Address 840 Shijo, kashihara 634-8522, Japan
TEL 0744-22-3051
Email soedatn@naramed-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsunenari Soeda
Organization Nara Medical University
Division name Cardiovascular Medicine
Zip code
Address 840 Shijo, kashihara 634-8522, Japan
TEL 0744-22-3051
Homepage URL
Email soedatn@naramed-u.ac.jp

Sponsor
Institute Nara Medical University
Institute
Department

Funding Source
Organization None
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
2018 Year 10 Month 10 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 Terminated
Date of protocol fixation
2018 Year 03 Month 06 Day
Date of IRB
2018 Year 03 Month 14 Day
Anticipated trial start date
2018 Year 12 Month 01 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 10 Month 10 Day
Last modified on
2019 Year 04 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034587

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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