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

• Status: Recruiting
• Trial end date: 2020-11-12
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Keun-Sik Hong
• Collaborators: Chung-Ang University Hosptial, Chung-Ang University College of Medicine; Ewha Womans University; Ewha Womans University Seoul Hospital; Hallym University Medical Center; Inje University; Korea University; Korea University Guro Hospital; Kyunghee University Medical Center; Myongji Hospital; Samsung Medical Center; Seoul National University Hospital; Seoul St. Mary's Hospital; Severance Hospital
• Treatments: Ezetimibe; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

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 imaging)

This is satisfied by meeting at least one of the following two criteria:

1. Patients who sustained stroke symptoms for more than 24 hours and had acute ischemic lesions on DWI.

2. 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:

1. Patients with ischemic stroke due to arteriosclerosis and LDL-C ≥ 100 mg / dL. (Class I; Level of Evidence B)

2. Patients with ischemic stroke due to arteriosclerosis and LDL-C <100 mg / dL. (Class I; Level of Evidence C)

3. 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:

1. Patients who had a baseline LDL-C level before the onset of a recent ischemic stroke and started statin therapy.

2. 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.

Exclusion Criteria:

1. Planned vascular intervention before the end of trial

2. Significant hepatic dysfunction (Aspartate Aminotransferase or Alanine Aminotransferase >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 prothrombin time International Normalized Ratio > 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. Patients with severe renal impairment (creatinine clearance <30 mL / min)

15. Other reasons for ineligibility judged by investigators