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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000018818
Receipt No. 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 2018/09/07

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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
Middle name
Last name Ikuo Inoue
Organization Saitama Medical University
Division name Dept. of Endocrinology and Diabetology
Zip code
Address 38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL 049-276-1875
Email i1901018@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ikuo Inoue
Organization Saitama Medical University
Division name Dept. of Endocrinology and Diabetology
Zip code
Address 38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL 049-276-1875
Homepage URL
Email i1901018@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University
Institute
Department

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
Address
Tel
Email

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 Enrolling by invitation
Date of protocol fixation
2015 Year 08 Month 26 Day
Date of IRB
Anticipated trial start date
2028 Year 12 Month 31 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

Other
Other related information

Management information
Registered date
2015 Year 08 Month 26 Day
Last modified on
2018 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021766

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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