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A prospective, multicenter, randomized, open-label trial to compare efficacy of pitavastatin plus ezetimibe versus high-dose statin on LDL cholesterol lowering in old age patients (=70) undergoing percutaneous coronary intervention

A prospective, multicenter, randomized, open-label trial to compare efficacy of pitavastatin plus ezetimibe versus high-dose statin on LDL cholesterol lowering in old age patients (=70) undergoing percutaneous coronary intervention

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0008414
Enrollment
488
Registered
2023-05-04
Start date
2023-05-01
Completion date
Unknown
Last updated
2023-05-30

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

Conditions

None listed

Interventions

Drug : This study will compare the efficacy and safety of two antiplatelet strategies in old age patients (=70) undergoing percutaneous coronary intervention (Livalozet70-PCI) (1)Pitavastatin 4mg/ Ez

Sponsors

The Catholic University of Korea, Seoul St. Mary's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Ages 70 years and older male/female 2)Patients with ASCVD((Atherosclerotic Cardiovascular Disease)) who underwent percutaneous coronary intervention 3)Patient agreed to participate in the protocol

Exclusion criteria

Exclusion criteria: 1)Familial hyperlipidemia 2)LDL-C =100mg/dL after taking high-dose statin or statin/ezetimibe combination therapy 3)Cancer with life expectancy = 1 year 4)History of severe liver disease (Child Pugh B or C) 5)History of hypersensitivity or contraindication to ezetimibe, pitavastatin, or rosuvastatin 6)End-stage renal disease on HD/PD or kidney transplantation 7)Patients who participated in other clinical trial(s) within 3 months after the screening (except non-interventional observational study)

Design outcomes

Primary

MeasureTime frame
Time-course changes (% change) in mean serum levels of fasting low density lipoprotein-cholesterol (LDL-C);Time-course changes in SAMS (statin-associated myalgia) questionnaire score—

Secondary

MeasureTime frame
Change from Baseline in fasting LDL-C target level (55mg/dL) achievement rate ;Change from Baseline in fasting LDL-C target level (70mg/dL) achievement rate ;Change from Baseline in other fasting lipid profile components (high density lipoprotein-cholesterol (HDL-C), triglyceride (TG), total cholesterol (TC), Apolipoprotein B (Apo-B), Apolipoprotein A1 (Apo-A1), Lipoprotein(a), HDL/TG, LDL/HDL ratio, non-HDL/LDL, TC/HDL, Apo-B/Apo-A1 ratio);Change from Baseline in HOMA-IR(Homeostatic Model Assessment for Insulin Resistance), HOMA-ß(Homeostatic Model Assessment for ß cell function );Change from Baseline in serum fasting blood glucose, HbA1c, Fasting serum insulin level ;Change from Baseline in serum AST(ASpartate Transaminase), ALT(ALanine Transaminase) level ;Change from Baseline in serum CPK(creatine phosphokinase), CK-MB(Creatine kinase MB Fraction) level ;Change from Baseline in serum hsCRP(high sensitivity C-Reactive protein) level—

Countries

Korea, Republic of

Contacts

Public ContactJAEHYUN LEE

The Catholic University of Korea, Seoul St. Mary's Hospital

jaehyunlee772@gmail.com+82-70-4278-9085

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026