UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034434
Receipt number 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 14:41:00

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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 or person

Institute

Nara Medical University

Institute

Department

Personal name



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

Value
https://center6.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