Ezetimibe lipid lowering trial on cholesterol absorption-synthesis and prevention of atherrosclerosis in 75 or older with hight risk hyper LDL cholesterolemia

Ezetimibe lipid lowering trial on cholesterol absorption-synthesis and prevention of atherrosclerosis in 75 or older with hight risk hyper LDL cholesterolemia - KEEP(Kyushu Elderly Ezetimibe Phytosterol study)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000017769

Enrollment

1300

Registered

2015-06-02

Start date

2015-04-01

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

Hyper-LDL-cholesterolemia

Interventions

ezetimibe and diet diet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) High-risk outpatients with hyper-LDL-cholesterolemia (serum LDL-cholesterol levels 140mg/dL) aged 75 years and older (at the time of written informed consent) of the both sexes (LDL-cholesterol levels are calculated with Friedewald Formula). (2) At least one of the following factors 1. DM 2. Hypertension 3. Low-HDL-cholesterolemia 4. Hypertriglyceridemia 5. Current smoking 6. History of cerebral infarction 7. PAD

Exclusion criteria

Exclusion criteria: (1)Serum TG level400 mg/dL (2) History of myocardial infarction (3) History of PCI or CABG (4) Angina pectoris requiring treatment (5) Recent history of stroke(within 6 months) (6) 1. AST100 IU/L 2. ALT100 IU/L 3. liver chirosis (7) Serum creatinine level3.0 mg/dL (8) Cancer (9) Dementia (10) Familial hyperchoresterolemia (11) Atrial fibrillation (12) Allergy to ezetimibe (13) Patients participating in other clinical trials (14) Patients inappropriate for the trial judged by investigators

Design outcomes

Primary

Measure	Time frame
0 to 24weeks (1)changes in cholesterol absorption and synthesis (2)changes in inflammation markers (3)changes in lipoproteins(RLPcholesterol, small dense LDL etc), oxydised phospholipid, oxdised cholesterol) (4)NT-proBNP	—

Secondary

Measure	Time frame
relation to composite cardiovascular events(same as EWTOPIA75)	—

Countries

Japan

Contacts

Public ContactJun Sasaki,MD,PhD

International University of Health and Welfare Department of medical treatment for health

fukuoka-shiken@iuhw.ac.jp092-407-0434

Outcome results

None listed

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