NCT04080310

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-03-15
• Primary completion: 2019-06-15
• Completion: 2019-09-17
• First posted: 2019-09-06
• Last updated: 2020-03-20

Locations

2 sites across 1 country: South Korea