KCT0008455进行中（未招募）Unknown
Switch to rosuvastatin plus ezetimibe treatment from statin monotherapy for Target LDL-C goal achievement in patients with ischemic stroke, TIA or cerebral atherosclerosis: A multi-center, open-label, single arm phase IV trial (S-ROSETTA-Stroke)
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 410
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. Patients with ischemic stroke, transient ischemic attack, or cerebrovascular artery disease
- •2. Patients receiving statin monotherapy
- •- Patients receiving concomitant therapy with Omega-3 or fibrate medications are also eligible for enrollment: the same Omega-3 or fibrate medication should be maintained during the clinical trial period.
- •- Patients taking other statins or statin/ezetimibe combination therapy are excluded.
- •3. Patients with a baseline LDL-C level of 70 mg/dL or higher
- •- The measurement taken during routine clinical visits within the past 3 months will be used as the baseline value.
- •4. Adult men and women aged 19 years or older
- •5. Patients who voluntarily provide written consent to participate in this study.
排除标准
- •1. Subjects who are planning cardiovascular intervention before the completion of this clinical trial
- •2. Subjects with significant hepatic impairment (ALT or AST levels > 120 IU/L)
- •3. Subjects with known allergy or contraindication to Rosuvastatin or Ezetimibe
- •4. Alcohol or drug abusers
- •5. Pregnant or lactating women
- •6. Patients with severe anemia: Hb level <10 g/dL for men and <9 g/dL for women
- •7. Women who cannot use contraception during the study period
- •8. Subjects with a life expectancy of less than 6 months due to malignancy or other serious health conditions affecting life expectancy
- •9. Subjects receiving Cyclosporine or protease therapy
- •10. Patients with severe renal impairment due to end-stage renal disease (creatinine clearance <30mL/min)
- •11. Subjects who cannot comply with the clinical trial procedures specified in the protocol
- •12. Subjects who have participated in another clinical trial within the past 3 months
- •13. Employees of the investigator's institution or research site who are directly involved in the conduct of the study
- •14. Other individuals who are deemed by the investigator to be unsuitable for participation in the clinical trial.
研究者
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