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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)

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) - PIONEERs Study 3

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000018818
Enrollment
300
Registered
2015-09-14
Start date
2025-01-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

Interventions

Rosuvastatin group: start from rosuvastatin 5mg, increased to 20mg, Atorvastatin group: start from atorvastatin 10mg, increased to 40mg Statin and evolocumab combination group: combination therap

Sponsors

Saitama Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: patients considered as inadequated by the investigator and doctor

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactIkuo Ikuo Inoue

Saitama Medical University Dept. of Endocrinology and Diabetology

i1901018@saitama-med.ac.jp049-276-1875

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026