UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023483 |
|---|---|
| Receipt number | R000027050 |
| Scientific Title | Efficacy and safety of PCSK9 inhibitor for dyslipidemia |
| Date of disclosure of the study information | 2016/08/04 |
| Last modified on | 2024/09/09 11:04:06 |
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Basic information
Public title
Efficacy and safety of PCSK9 inhibitor for dyslipidemia
Acronym
EVOLUTION trial (effects of EVOLocUmab on lipid and oxidaTIve stress biOmarkers in high-risk patieNts with Cardiovascular disease)
Scientific Title
Efficacy and safety of PCSK9 inhibitor for dyslipidemia
Scientific Title:Acronym
EVOLUTION trial (effects of EVOLocUmab on lipid and oxidaTIve stress biOmarkers in high-risk patieNts with Cardiovascular disease)
Region
| Japan |
Condition
Condition
refractory dyslipidemia
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of PCSK9 inhibitor (Evolocumab).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
LDL, HDL, T-cho(Pre, 1M, 3M, 6M, 1Y, 2Y)
Key secondary outcomes
Pre, 6M, 1Y, 2Y
1) FMD
2) carotis echo
3) ABI
Pre, 3M, 6M, 1Y, 2Y
4) U-alb, U-type IV collagen
5) cystatin C, ox-LDL, Lp (a), EPA/AA, Apo A1, B, E, TG
6) Cr,eGFR
7) complications
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
PCSK9 inhibitor (repasa) for patients with refractory dyslipidemia
140mg/every 2 weeks for 24 months
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
refractory dyslipidemia
Key exclusion criteria
Doctor's decision not to register to this regimen
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Sezai |
Organization
Nihon University School of medicine
Division name
Department of Cardiovascular Surgery
Zip code
1738610
Address
30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
TEL
03-3982-8111
asezai.med@gmail.com
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Sezai |
Organization
Nihon University School of Medicine
Division name
Department of Cardiovascular Surgery
Zip code
1738610
Address
30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
TEL
03-3982-8111
Homepage URL
asezai.med@gmail.com
Sponsor or person
Institute
Sekino Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sekino Laboratory
Address
3-28-3 ikebukuro, Toshima-ku, Tokyo, Japan
Tel
03-3986-5501
skn-np@sekino-hospital.com
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
関野病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 04 | 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
| 2016 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2020 | 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
| 2016 | Year | 08 | Month | 04 | Day |
Last modified on
| 2024 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027050
