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NCT Number: NCT04080310

Efficacy and Safety of Combination Therapy of Moderate-intensity Statin and Ezetimibe Compared to High-intensity Statin

This study is a multicenter, randomized, open-label, parallel, phase IV trial.

The purpose of this study efficacy and safety of combination therapy of moderate-intensity statin and ezetimibe compared to high-intensity statin.

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Key information

Conditions

Cardiovascular Diseases

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea

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About this study

The study is planned to include 272 patients with a clinical atherosclerotic cardiovascular disease requiring optimal statin therapy.

After enrollment, subjects are randomized into two groups in a 1:1 manner. The combination therapy group will receive a single-pill combination of rosuvastatin 10 mg and ezetimibe 10 mg once daily.

The subjects in the intensive statin group will receive rosuvastatin 20 mg once daily.

Subjects will visit at weeks 12 and 24 to identify medication adherence and clinical side effects.

The primary endpoint of this study is a % change of low-density lipoprotein cholesterol at 12 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged between 19 and 75 years
  • Presence of atherosclerotic cardiovascular disease Coronary artery disease
  • History of acute coronary syndrome
  • Stable or unstable angina
  • History of coronary revascularization Stroke or TIA Peripheral arterial disease, history of peripheral arterial revascularization
  • Patients who have been taking lipid-lowering agents (statin or ezetimibe) for ≥4 weeks at the time of randomization
  • Patients who gave informed consent

Exclusion criteria

  • Patients who have used lipid-lowering agents other than statin or ezetimibe within the last 3 months
  • A serum triglyceride on fasting >400 mg/dL
  • A history of muscular symptoms or rhabdomyolysis due to the use of statin
  • Hypersensitivity to rosuvastatin or ezetimibe
  • Labeled contraindications to rosuvastatin or rosuvastatin Severe renal impairment (CrCl <30 mL/min by Cockcroft-Gault formula or estimated GFR <30 mL/min / 1.73 m2 by MDRD equation) ALT, AST ≥3 × ULN or active liver disease CPK ≥3 × ULN
  • Enrollment of other clinical trials within 30 days
  • Any other issues that the treating physician assumes ineligible for participation in the trial

Treatment and study plan

Efficacy and safety of combination therapy of moderate-intensity statin and ezetimibe compared to high-intensity statin

Drug

This study is a multicenter, randomized, open-label, parallel, phase IV trial. The study is planned to include 272 patients with clinical ASCVD requiring optimal statin therapy.

After enrollment, subjects are randomized into two groups in a 1:1 manner. patients in combination therapy group(rosuvastation 10mg and ezetimibe 10mg daily) will be provided a fixed-dose single pill comibation and patients in the intensive statin group will receive rosuvastatin 20mg daily.

Primary outcomes

  1. % change of low-density lipoprotein cholesterol

    Time frame: at 12 weeks

    %change of LDL-C = (LDL-C at 12 weeks) - (LDL-C at baseline)/LDL-C at baseline * 100

Secondary outcomes

  1. % change of serum cholesterol level

    Time frame: at 12 and 24 weeks

    total cholesterol, LDL, HDL cholesterol, triglyceride (mg/dL)

  2. % change of high-sensitivity C-reactive protein

    Time frame: at 12 and 24 weeks

    hs-CRP(mg/dL)

  3. % change of fasting glucose

    Time frame: at 12 and 24 weeks

    fasting plasma glucose(mg/dL)

  4. % change of homeostatic model assessment for insulin resistance(HOMA-IR)

    Time frame: at 12 and 24 weeks

    HOMA-IR = glucose * insulin / 405(glucose mg/dL , insulin uIU/mL)

  5. proportion of participant with statin-associated muscle symptoms

    Time frame: at 12 and 24 weeks

    occurrence of statin-associated muscle symptoms

  6. proportion of participant with creatinine phosphokinase elevation

    Time frame: at 12 and 24 weeks

    proportion of CPK elevation ≥4 or ≥10 upper normal of limit

  7. proportion of participant with liver function test abnormality

    Time frame: at 12 and 24 weeks

    proportion of AST/ALT elevation ≥4 or ≥10 upper normal of limit

  8. proportion of participant with major adverse cardiovascular and cerebrovascular events(MACCE)

    Time frame: at 12 and 24 weeks

    MACCE defined as a composite of the followings : cardiovascular death, acute myocardial infarction, unstable angina, stroke

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Collaborators

  • Yuhan Corporation

Registry information

Official study title

Efficacy and Safety of Combination Therapy of Moderate-intensity Statin and Ezetimibe Compared to High-intensity Statin: Study Protocol for a Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 6, 2019
Registry last updated
Mar 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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