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)

Not Applicable

Active, not recruiting

Conditions: Endocrine, nutritional and metabolic diseases

Registration Number: KCT0008455

Lead Sponsor: Inje University Ilsan Paik Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Active, not recruiting

Sex: All

Target Recruitment: 410

Inclusion Criteria

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.

Exclusion Criteria

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.