UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040727 |
|---|---|
| Receipt number | R000046494 |
| Scientific Title | The crossover randomized controlled clinical trial with Alirocumab and Evolocumab:CROSS ALIVE Study |
| Date of disclosure of the study information | 2020/06/12 |
| Last modified on | 2023/05/30 13:02:15 |
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Basic information
Public title
The crossover randomized controlled clinical trial with Alirocumab and Evolocumab:CROSS ALIVE Study
Acronym
The crossover randomized controlled clinical trial with Alirocumab and Evolocumab:CROSS ALIVE Study
Scientific Title
The crossover randomized controlled clinical trial with Alirocumab and Evolocumab:CROSS ALIVE Study
Scientific Title:Acronym
The crossover randomized controlled clinical trial with Alirocumab and Evolocumab:CROSS ALIVE Study
Region
| Japan |
Condition
Condition
The crossover randomized controlled clinical trial with Alirocumab and Evolocumab:CROSS ALIVE Study
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The crossover randomized controlled clinical trial with Alirocumab and 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, Ultracentrifugation, gel filtration, ion exchange chromatography
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
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
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 3 months after the switch.
Interventions/Control_2
Before switching from 140 mg, 420 mg evolocumab to 75 mg, 150 mg arilocumab, and 3 months after the switch.
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
20
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
Saitama Medical University
Dept. of Endocrinology and Diabetology
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
Saitama Medical University Dept. of Endocrinology and Diabetology
Address
38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
Tel
049-276-1204
i1901018@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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | 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
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2020 | Year | 06 | Month | 11 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2035 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2035 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2035 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 11 | 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=R000046494
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
