UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040373 |
|---|---|
| Receipt number | R000046077 |
| Scientific Title | Individual clinical efficacy and safety of low-density lipoprotein cholesterol-lowering by switching from arilocumab to evolocumab(SWITCH From Arilocumab To Evolocumab study:Switch fate Study). |
| Date of disclosure of the study information | 2020/05/12 |
| Last modified on | 2023/05/30 12:59:48 |
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Basic information
Public title
Prospective Study of Patients Switched from arilocumab to evolocumab(SWITCH From Arilocumab To Evolocumab study:Switch fate Study)
Acronym
Switch from arilocumab to evolocumab(SWITCH From Arilocumab To Evolocumab study:Switch fate Study)
Scientific Title
Individual clinical efficacy and safety of low-density lipoprotein cholesterol-lowering by switching from arilocumab to evolocumab(SWITCH From Arilocumab To Evolocumab study:Switch fate Study).
Scientific Title:Acronym
Switch fate Study
Region
| Japan |
Condition
Condition
Hyperlipidemia
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Individual clinical efficacy and safety of low-density lipoprotein cholesterol-lowering therapy by switching from arilocumab to evolocumab
Basic objectives2
Others
Basic objectives -Others
Changes in LDL quantity and quality depending on the degree of LDL decline
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Lipid profile (TC,TG,HDL-C, Friedewald LDL-C,small dense LDL,IDL,Lp(a),LDL oxidation ability,LDL stability,oxidized LDL,3%PAGE,Agarose gel electrophoresis,electronegative LDL),apo protein, apoE phenotype
Key secondary outcomes
Cr, BUN, Urinal analysis, GOT, GPT, CK, (following in the case of DM), fasting blood glucose, HbA1, hematologic changes such as thrombocytopenia, etc., early-phase and late-phase of allergic reaction to PCSK9 inhibitor.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Before switching from 75 mg, 150 mg arilocumab to 140 mg, 420 mg evolocumab, and 6 months and 1 year after the switch.
Interventions/Control_2
Evolocumab 140mg, 420mg continued: at start of intervention, 6 months after intervention, 1 year after intervention
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)-3) 3 examine group
1)T2DM with 120 mg/dl or more than 100 mg/dl LDL-C
2)Patients of JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2017 CategoryIII (Diabetes patients are excepted) with 120 mg/dl or more than 100 mg/dl LDL-C
3)Patients of JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2017 Secondary prevention with 100 mg/dl or more than 70 mg/dl LDL-C
Key exclusion criteria
A patient with the side-effects past in statin medication
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ikuo |
| Middle name | |
| Last name | Inoue |
Organization
Saitama Medical University
Division name
Dept. of Endocrinology and Diabetology
Zip code
350-0495
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL
049-276-1875
i1901018@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Ikuo |
| Middle name | |
| Last name | Inoue |
Organization
Saitama Medical University
Division name
Dept. of Endocrinology and Diabetology
Zip code
350-0495
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL
049-276-1875
Homepage URL
i1901018@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Dept. of Endocrinology and Diabetology
Institute
Department
Personal name
Funding Source
Organization
Non
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
IRB
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
Tel
049-276-1354
hirb@saitama-med.ac.jp
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
埼玉医科大学
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | Month | 12 | 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
| 2020 | Year | 06 | Month | 01 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2020 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2020 | Year | 05 | Month | 12 | Day |
Last modified on
| 2023 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046077
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2020/05/13 | A Sudden Onset of Severe Thrombocytopenia WhileUsing Evolocumab.pdf |
