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

Keun-Sik Hong

Status and phase: Completed; Phase 4

Conditions: Stroke, Ischemic

Treatments: Drug: Active Comparator: Rosuvastatin 20mg; Drug: Experimental: Rosuvastatin/Ezetimibe 10

Study type: Interventional

Funder types: Other

Identifiers

NCT03993236

ROSETTA-Stroke

Details and patient eligibility

About

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

Full description

The purpose of this study is to compare the efficiency and safety on the target LDL-C goal achievement between rosuvastatin 10 mg plus ezetimibe 10 mg (rosuvastatin/ezetimibe 10/10 mg) once daily versus rosuvastatin 20 mg once daily in patients with recent ischemic stroke.

The target LDL-C goal achievement rate in patients with recent ischemic stroke has not been well studied. In particular, no clinical studies have been conducted comparing the efficacy and safety of low-dose rosuvastatin plus ezetimibe with high-dose rosuvastatin single agent for achieving target LDL-C levels.

In this trial, the investigators aim to compare the efficacy of the target LDL-C achievement between rosuvastatin 10 mg plus ezetimibe 10 mg (rosuvastatin/ezetimibe 10/10 mg) and rosuvastatin 20 mg in patients with recent ischemic stroke.

For this trial, more than 292 patients (584 total) per group will be enrolled.

Subjects who were satisfied with the inclusion/exclusion criteria of this trial and who agreed to participate in the clinical trial in writing were randomly assigned to a 1:1 ratio in the experimental group (the low-dose combination of rosuvastatin plus ezetimibe) and comparator group (high-dose rosuvastatin).

The duration of administration of the drug for clinical trials is 90 days (±14 days), and the efficacy and safety evaluation parameters are compared with baseline.

Enrollment: 584 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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584 participants in 2 patient groups

Rosuvastatin/Ezetimibe 10/10mg

Experimental group

Description:

The experimental group is orally administered with rosuvastatin 10 mg plus ezetimibe 10 mg combination once daily for 90 days.

Treatment:

Drug: Experimental: Rosuvastatin/Ezetimibe 10

Rosuvastatin 20mg

Active Comparator group

Description:

The comparator group is orally administered with rosuvastatin 20 mg single agent once daily for 90 days

Treatment:

Drug: Active Comparator: Rosuvastatin 20mg