drugset / Trial / NCT03993236
Study on Rosuvastatin+Ezetimibe and Rosuvastatin for LDL-C Goal in Patients With Recent Ischemic Stroke
Phase 4
Completed
584 enrolled
Keun-Sik Hong
Chung-Ang University Hospital · collabEwha Womans University Seoul Hospital · collabHallym University Medical Center · collabInje University Ilsan Paik Hospital · collabKorea University Ansan Hospital · collabKorea University Guro Hospital · collabKyunghee University Medical Center · collabMyongji Hospital · collabSamsung Medical Center · collabSeoul National University Hospital · collabSeoul St. Mary's Hospital · collabSeverance Hospital · collab
RandomizedParallel-groupOpen-labelSupportive care
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
Timeline
- Start
- 2019-09-09
- Primary completion
- 2021-09-27
- Completion
- 2021-09-27
Outcome
Met primary endpoint
paper The primary endpoint was achieved in 198 patients (72.5%) in the ROS10/EZT10 group and 148 (57.6%) in the ROS20 group PMID 37032475 ↗
paper odds ratio [95% confidence interval], 1.944 [1.352-2.795]; P= 0.0003 PMID 37032475 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ezetimibe | Unknown | 10 mg | Oral |
| Comparator | Rosuvastatin | Small molecule | 10 mg | Oral |
| Comparator | Rosuvastatin | Small molecule | 20 mg | Oral |