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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
