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

Cardiovascular Diseases Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04080310
• Other study ID #: YMC033
• Status: Completed
• Phase: Phase 4
• Start date: March 15, 2018
• Est. completion date: September 17, 2019

Study information

• Verified date: March 2020
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: September 17, 2019
• Est. primary completion date: June 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Aged between 19 and 75 years

2. 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

3. Patients who have been taking lipid-lowering agents (statin or ezetimibe) for =4 weeks at the time of randomization

4. Patients who gave informed consent

Exclusion Criteria:

1. Patients who have used lipid-lowering agents other than statin or ezetimibe within the last 3 months

2. A serum triglyceride on fasting >400 mg/dL

3. A history of muscular symptoms or rhabdomyolysis due to the use of statin

4. Hypersensitivity to rosuvastatin or ezetimibe

5. 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

6. Enrollment of other clinical trials within 30 days

7. Any other issues that the treating physician assumes ineligible for participation in the trial

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Drug:
• 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 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% 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	% change of serum cholesterol level	total cholesterol, LDL, HDL cholesterol, triglyceride (mg/dL)	at 12 and 24 weeks
Secondary	% change of high-sensitivity C-reactive protein	hs-CRP(mg/dL)	at 12 and 24 weeks
Secondary	% change of fasting glucose	fasting plasma glucose(mg/dL)	at 12 and 24 weeks
Secondary	% change of homeostatic model assessment for insulin resistance(HOMA-IR)	HOMA-IR = glucose * insulin / 405(glucose mg/dL , insulin uIU/mL)	at 12 and 24 weeks
Secondary	proportion of participant with statin-associated muscle symptoms	occurrence of statin-associated muscle symptoms	at 12 and 24 weeks
Secondary	proportion of participant with creatinine phosphokinase elevation	proportion of CPK elevation =4 or =10 upper normal of limit	at 12 and 24 weeks
Secondary	proportion of participant with liver function test abnormality	proportion of AST/ALT elevation =4 or =10 upper normal of limit	at 12 and 24 weeks
Secondary	proportion of participant with major adverse cardiovascular and cerebrovascular events(MACCE)	MACCE defined as a composite of the followings : cardiovascular death, acute myocardial infarction, unstable angina, stroke	at 12 and 24 weeks