KCT0003890已完成未知
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
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 584
研究概览
简要总结
Of 584 randomized, 530 were included in the modified intention-to-treat analysis. The primary endpoint of LDL-C reduction =50% from baseline was achieved in 198 patients (72.5%) in the ROS10/EZT10 group and 148 (57.6%) in the ROS20 group of the modified ITT population, and the difference was significant (odds ratio [95% confidence interval], 1.944 [1.352–2.795]; p=0.0003) In this randomized trial, we found that the combination of moderate-intensity rosuvastatin 10 mg plus ezetimibe 10 mg was superior to high-intensity rosuvastatin 20 mg alone for LDL-C reduction in patients with recent ischemic stroke who initiated lipid-lowering therapy. The adverse event rates did not differ between the 2 groups.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. Patients with recent ischemic stroke who meet both 1) and 2) criteria below.
- •1) Patients with acute ischemic stroke confirmed by DWI(diffusion-weighted image)
- •This is satisfied by meeting at least one of the following two criteria:
- •A) Patients who sustained stroke symptoms for more than 24 hours and had acute ischemic lesions on DWI.
- •B) Patients with acute ischemic lesions in DWI who had improved symptoms within 24 hours.
- •2) Patients with ischemic stroke within 90 days.
- •2. Statin therapy indicated according to the recommendations of the 2014 American Heart Association/American Stroke Association guidelines.
- •This is accomplished by meeting at least one of the following three criteria:
- •A) Patients with ischemic stroke due to arteriosclerosis and LDL-C = 100 mg / dL. (Class I; Level of Evidence B)
- •B) Patients with ischemic stroke due to arteriosclerosis and LDL-C <100 mg / dL. (Class I; Level of Evidence C)
- •C) Patients who require statin therapy due to other associated atherosclerotic cardiovascular disease. (Class I; Level of Evidence A).
- •3. Patients without statin dose within 28 days before ischemic stroke.
- •4. Patients who measured baseline LDL-C levels after an ischemic stroke. This is satisfied by meeting at least one of the following two criteria:
- •A) Patients who had a baseline LDL-C level before the onset of a recent ischemic stroke and started statin therapy.
- •B) Patients hospitalized with acute ischemic stroke who had baseline LDL-C levels after initiation of statin therapy should meet both of the following conditions:
- •(1) Patients with LDL-C levels measured within 3 days after initiation of statin therapy
- •(2) Patients in whom randomization and administration of the study drug can be administered within 7 days after baseline LDL-C measurement.
- •5. Adults over 19 years.
- •6. Those who voluntarily agreed in writing to the trial.
排除标准
- •1. Planned vascular intervention before the end of trial
- •2. Significant hepatic dysfunction (AST or ALT >120 IU/L)
- •3. Allergy or contraindication to rosuvastatin or ezetimibe
- •4. Alcohol or drug addiction
- •5. Pregnancy or breast-feeding
- •6. Severe anemia: Hb level <10 g/dL for men and <9 g/dL for women
- •7. Bleeding diathesis: platelet count <100,000/µl or PT INR > 1·7
- •8. Inability or unwillingness to comply with study-related procedures
- •9. Employees of the investigator or study center, with direct involvement in the current study
- •10. Women unwilling to continue contraception during the study period
- •11. Participation in other clinical trials within three-month
- •12. Malignancy or other serious medical conditions with a life expectancy <6 months
- •13. Treatment with protease inhibitors or cyclosporine
- •14. Other reasons for ineligibility judged by investigators
研究者
相似试验
已完成
4 期
Study on Rosuvastatin+Ezetimibe and Rosuvastatin for LDL-C Goal in Patients With Recent Ischemic StrokeStroke, IschemicNCT03993236Keun-Sik Hong584
Unknown
4 期
High-intensity Rosuvastatin vs. Moderate-intensity Rosuvastatin/Ezetimibe in High Atherosclerotic Cardiovascular Disease Risk Patients With Type 2 DiabetesAtherosclerotic Cardiovascular DiseaseType 2 DiabetesNCT03403556Yuhan Corporation140
招募中
4 期
Low Dose Rosuvastatin Plus Ezetimibe Versus High-dose Rosuvastatin in AMIStatin Adverse ReactionMyocardial InfarctionHMG-CoA Reductase Inhibitor ToxicityNCT04499859Kiyuk Chang, MD,PhD3,548
已完成
1 期
Assessment of Potential Interaction Between Ezetimibe and Rosuvastatin in Healthy Subjects With High Cholesterol (P03317)HypercholesterolemiaAtherosclerosisNCT00651144Organon and Co40
已完成
3 期
Evaluating the Efficacy and Safety of Co-administrated Rosuvastatin/Ezetimibe and Telmisartan/AmlodipineHypertensionHypercholesterolemiaNCT04158076Addpharma Inc.131