NCT05705804

Brief Summary

The purpose of this study was to investigate the effect of pitavastatin or pitavastatin and ezetimibe combination therapy on glucose metabolism compared to atorvastatin in patients with atherosclerotic cardiovascular disease with metabolic syndrome.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 31, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

June 13, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

July 6, 2023

Status Verified

July 1, 2023

Enrollment Period

1.6 years

First QC Date

January 18, 2023

Last Update Submit

July 4, 2023

Conditions

DyslipidemiasAtherosclerotic Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • Change form baseline homeostatic model assessment for insulin resistance (HOMA-IR) at 24 weeks

    Changes of homeostatic model assessment for insulin resistance (HOMA-IR) form baseline to 24 weeks will be compared among the three groups.

    At 24 weeks

Secondary Outcomes (10)

  • Proportion of fasting glucose ≥100 mg/dL

    At 24 weeks

  • Proportion of HbA1C ≥6.5%

    At 24 weeks

  • Proportion of new-onset diabetes mellitus

    At 24 weeks

  • Changes of HOMA-β at 24 weeks

    At 24 weeks

  • Changes of fasting glucose at 24 weeks

    At 24 weeks

  • +5 more secondary outcomes

Study Arms (3)

Group P

EXPERIMENTAL

Pitavastatin 4mg group

Drug: Pitavastatin

Group PE

EXPERIMENTAL

Pitavastatin 4 mg Ezetimibe 10 mg combined administration group

Drug: Pitavastatin plus Ezetemibe

Group A

ACTIVE COMPARATOR

Atorvastatin 40 mg administration group

Drug: Atorvastatin

Interventions

PitavastatinDRUG

Pitavastatin 4 mg will be given.

Group P
Pitavastatin plus EzetemibeDRUG

Pitvastatin 4 mg plus ezetemibe 10 mg will be given.

Group PE
AtorvastatinDRUG

Atorvastatin 40 mg will be given.

Group A

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with dyslipidemia
  • Patient with diagnosis of clinical atherosclerotic cardiovascular disease (acute coronary syndrome, history of myocardial infarction, stable or unstable angina, history of coronary artery reperfusion, stroke or transient stroke, history of peripheral arterial disease or peripheral arterial reperfusion)
  • Patients with metabolic syndrome but without diabetes

You may not qualify if:

  • Diagnosis of clinical atherosclerotic cardiovascular disease within 1 year
  • Acute liver disease or persistent unexplained serum AST or ALT three times the upper limit of normal
  • Allergy or hypersensitivity to statins or ezetimibe
  • Solid organ transplant recipients
  • History of side effects requiring discontinuation of statin administration
  • Pregnant women, potentially pregnant or lactating women
  • Life expectancy less than 3 years
  • If it is judged that follow-up for more than 1 year is not possible
  • If the patient is unable to understand or read the consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

DyslipidemiasAtherosclerosis

Interventions

pitavastatinAtorvastatin

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Byeong-Keuk Kim

    Severance Cardiovascular Hospital, YONSEI UNIVERSITY COLLEGE OF MEDICINE

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Byeong-Keuk Kim

CONTACT

82-2-2228-8465KIMBK@yuhs.ac

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2023

First Posted

January 31, 2023

Study Start

June 13, 2023

Primary Completion

February 1, 2025

Study Completion

April 1, 2025

Last Updated

July 6, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)