UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018818 |
|---|---|
| Receipt number | R000021766 |
| Scientific Title | Trail against hyperlipidemia Patients with high risks to Investigate the effect ON small dense ldl & idl by using middlE dosE rosuvastatin, atrovastatin, psSk-9 inhibitor(relationship of blood ANGPTL, Sortilin, miRNA and so on level) (PIONEERs in Saitama Study 3) |
| Date of disclosure of the study information | 2015/09/14 |
| Last modified on | 2025/05/12 17:28:02 |
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Basic information
Public title
Trail against hyperlipidemia Patients with high risks to Investigate the effect ON small dense ldl & idl by using middlE dosE rosuvastatin, atrovastatin, psSk-9 inhibitor(relationship of blood ANGPTL, Sortilin, miRNA and so on level) (PIONEERs in Saitama Study 3)
Acronym
PIONEERs Study 3
Scientific Title
Trail against hyperlipidemia Patients with high risks to Investigate the effect ON small dense ldl & idl by using middlE dosE rosuvastatin, atrovastatin, psSk-9 inhibitor(relationship of blood ANGPTL, Sortilin, miRNA and so on level) (PIONEERs in Saitama Study 3)
Scientific Title:Acronym
PIONEERs Study 3
Region
| Japan |
Condition
Condition
Hypercholesterolemia
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The lipid medical treatment by rosuvastatin or atrovastatin or PCSK-9 inhibitor a high risk hyperlipidemia patient or statin intolerance patient examines propriety aiming at disappearance of small dense LDL and IDL by 3%poly-acrylamide gel electrophoresis(PAGE) metod, gradient gel electrophoresis(GGE), and electron microscope. Small dense LDL and IDL were determined and compaired by 3%PAGE and agarose gel electrophoresis method. 3%PAGEs were peformed two Commercial kits(Lipopho System and Lipopho AS System). In particular, Lipopho AS System was determined by Gaussian fitting method to evaluate the small dense LDL and IDL. Moreover, the CAC scoring (Agatston Units, AUs) and stenosis and the event rate of cerebrovascular and cardiovascular disease, blood ANGPTL, Sortilin, miRNA and so on level were estimated in 300 patients receiving coronary computed tomographic angiography (CCTA).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lipid profile (TC,TG,HDL-C, Friedewald LDL-C, small dense LDL,IDL), apo protein, apoE phenotype Lp(a), dementia/cognitive function after 6 months, 12 months, 2 years, 3 years, 4 years, 5 years to treatment
Key secondary outcomes
The CAC scoring (Agatston Units, AUs) and stenosis and the event rate of cerebrovascular and cardiovascular disease, blood ANGPTL, Sortilin, miRNA and so on level after 6 months, 12 months, 2 years, 3 years, 4 years, 5 years treatment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Rosuvastatin group: start from rosuvastatin 5mg, increased to 20mg,
Interventions/Control_2
Atorvastatin group: start from atorvastatin 10mg, increased to 40mg
Interventions/Control_3
Statin and evolocumab combination group: combination therapy with a statin and PCSK-9 inhibitor
Interventions/Control_4
statin intolerance group: combination therapy with a statin and/or PCSK-9 inhibitor
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)-4) 4 examine group
1)T2DM with 70 mg/dl or more than 70 mg/dl LDL-C
2)Patients of JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2017 CategoryIII (Diabetes patients are excepted) with 70 mg/dl or more than 70 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 100 mg/dl LDL-C
4)statin intolerance patients
Key exclusion criteria
patients considered as inadequated by the investigator and doctor
Target sample size
300
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 | Ikuo 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
Institute
Department
Personal name
Funding Source
Organization
Saitama Industrial Promotion Public Corporation (SIPC)
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama medical University
Address
Saitama medical University
Tel
0492791875
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
| 2015 | Year | 09 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
https://www.ncbi.nlm.nih.gov/pubmed/29951223
https://www.researchgate.net/publication/314118317_The_New_Molecular_Entity_Evolocumab_One_Kind_of_PCSK9_Inhibitor_Reduce_Plasma_Small_Size_LDL-Cholesterol_Levels_by_Using_a_New_Standardized_Method_of_Measuring_LDL_Size
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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 08 | Month | 26 | Day |
Date of IRB
| 2015 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2030 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 26 | Day |
Last modified on
| 2025 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021766
