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

NCT04080310 | Completed Phase 4

• 1 other identifier: YMC033
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• % change of low-density lipoprotein cholesterol

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

  at 12 weeks

Secondary Outcomes (8)

• % change of serum cholesterol level

  at 12 and 24 weeks

• % change of high-sensitivity C-reactive protein

  at 12 and 24 weeks

• % change of fasting glucose

  at 12 and 24 weeks

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

  at 12 and 24 weeks

• proportion of participant with statin-associated muscle symptoms

  at 12 and 24 weeks

Study Arms (2)

combination therapy group

ACTIVE COMPARATOR

The combination therapy group will receive a single-pill combination of rosuvastatin 10 mg and ezetimibe 10 mg once daily.

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

intensive statin group

OTHER

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

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

Interventions

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.

combination therapy group; intensive statin group

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead
• Yuhan Corporation: collaborator

Study Sites (2)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 06511, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: September 6, 2019
• Study Start: March 15, 2018
• Primary Completion: June 15, 2019
• Study Completion: September 17, 2019
• Last Updated: March 20, 2020

Record last verified: 2020-03

Locations

KR (2)