NCT03993236

Study on Rosuvastatin+Ezetimibe and Rosuvastatin for LDL-C Goal in Patients With Recent Ischemic Stroke

Moderate-intensity Rosuvastatin Plus Ezetimibe Versus High-intensity Rosuvastatin for Target LDL-C Goal Achievement in Patients With Recent Ischemic Stroke: a Randomized Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 584 (actual)
• Sponsor: Keun-Sik Hong · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

A randomized clinical trial for the comparison of the efficacy and safety of moderate-intensity rosuvastatin plus ezetimibe versus high-intensity rosuvastatin for target LDL-C goal achievement in patients with recent ischemic stroke

Detailed description

The purpose of this study is to compare the efficiency and safety on the target LDL-C goal achievement between rosuvastatin 10 mg plus ezetimibe 10 mg (rosuvastatin/ezetimibe 10/10 mg) once daily versus rosuvastatin 20 mg once daily in patients with recent ischemic stroke. The target LDL-C goal achievement rate in patients with recent ischemic stroke has not been well studied. In particular, no clinical studies have been conducted comparing the efficacy and safety of low-dose rosuvastatin plus ezetimibe with high-dose rosuvastatin single agent for achieving target LDL-C levels. In this trial, the investigators aim to compare the efficacy of the target LDL-C achievement between rosuvastatin 10 mg plus ezetimibe 10 mg (rosuvastatin/ezetimibe 10/10 mg) and rosuvastatin 20 mg in patients with recent ischemic stroke. For this trial, more than 292 patients (584 total) per group will be enrolled. Subjects who were satisfied with the inclusion/exclusion criteria of this trial and who agreed to participate in the clinical trial in writing were randomly assigned to a 1:1 ratio in the experimental group (the low-dose combination of rosuvastatin plus ezetimibe) and comparator group (high-dose rosuvastatin). The duration of administration of the drug for clinical trials is 90 days (±14 days), and the efficacy and safety evaluation parameters are compared with baseline.

Conditions

• Stroke, Ischemic

Interventions

Type	Name	Description
DRUG	Experimental: Rosuvastatin/Ezetimibe 10	* Rosuvastatin/Ezetimibe 10/10mg * orally administered once daily for 90 days
DRUG	Active Comparator: Rosuvastatin 20mg	* Rosuvastatin 20mg * orally administered once daily for 90 days

Timeline

• Start date: 2019-09-09
• Primary completion: 2021-09-27
• Completion: 2021-09-27
• First posted: 2019-06-20
• Last updated: 2024-10-03

Locations

12 sites across 1 country: South Korea