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

February 11, 2020 updated by: Keun-Sik Hong

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

584

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Keun-Sik Hong, MD., PhD.
  • Phone Number: 82-31-910-7277
  • Email: nrhks@paik.ac.kr

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Not yet recruiting
        • Seoul National University Hospital
        • Contact:
      • Seoul, Korea, Republic of
        • Recruiting
        • Korea University Guro Hospital
        • Contact:
      • Seoul, Korea, Republic of
        • Recruiting
        • Severance Hospital, Yonsei University Health System
        • Contact:
      • Seoul, Korea, Republic of
        • Recruiting
        • Ewha Womans University Seoul Hospital
        • Contact:
      • Seoul, Korea, Republic of
        • Not yet recruiting
        • Chung-Ang University Hopital
        • Contact:
      • Seoul, Korea, Republic of
        • Recruiting
        • Kyung-Hee University Medical Center
        • Contact:
      • Seoul, Korea, Republic of
        • Recruiting
        • Samsung Medical Center, Sungkyunkwan University School of Medicine
        • Contact:
      • Seoul, Korea, Republic of
    • Gyeonggi-Do
      • Ansan-Si, Gyeonggi-Do, Korea, Republic of
        • Recruiting
        • Korea University Ansan Hospital
        • Contact:
      • Anyang-si, Gyeonggi-Do, Korea, Republic of
        • Recruiting
        • Hallym University Medical Center
        • Contact:
      • Goyang-Si, Gyeonggi-Do, Korea, Republic of
      • Ilsan, Gyeonggi-Do, Korea, Republic of
        • Recruiting
        • Inje University Ilsan Paik Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rosuvastatin/Ezetimibe 10/10mg
The experimental group is orally administered with rosuvastatin 10 mg plus ezetimibe 10 mg combination once daily for 90 days.
Drug: Experimental: Rosuvastatin/Ezetimibe 10
  • Rosuvastatin/Ezetimibe 10/10mg
  • orally administered once daily for 90 days
Other Names:
  • Rosuzet tab 10/10 mg
Active Comparator: Rosuvastatin 20mg
The comparator group is orally administered with rosuvastatin 20 mg single agent once daily for 90 days
Drug: Active Comparator: Rosuvastatin 20mg
  • Rosuvastatin 20mg
  • orally administered once daily for 90 days
Other Names:
  • Suvast tab 20mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The percentage of subjects with LDL-C decreased more than 50% at 90days (±14 days) compared to Baseline
Time Frame: Baseline, Visit 4(Day 90)
The percentage of subjects with LDL-C decreased more than 50% at 90days (±14 days) compared to Baseline
Baseline, Visit 4(Day 90)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of subjects with LDL-C less than 70 mg/dL at 90 days(±14 days)
Time Frame: Baseline, Visit 4(Day 90)
Percentage of subjects with LDL-C less than 70 mg/dL at 90 days(±14 days)
Baseline, Visit 4(Day 90)
The percentage of subjects with LDL-C decreased more than or less than 70 mg/dL at 90 days(±14 days)
Time Frame: Baseline, Visit 4(Day 90)
The percentage of subjects with LDL-C decreased more than or less than 70 mg/dL at 90 days(±14 days)
Baseline, Visit 4(Day 90)
The decrement of LDL-C at 90 days (±14 days) compared to baseline LDL-C (absolute difference and change)
Time Frame: Baseline, Visit 4(Day 90)
The decrement of LDL-C at 90 days (±14 days) compared to baseline LDL-C (absolute difference and change)
Baseline, Visit 4(Day 90)
The percentage of subjects achieved multiple lipid level (Total-C < 200mg/dL, LDL-C < 70mg/dL and triglyceride < 150mg /dL)
Time Frame: Baseline, Visit 4(Day 90)
The percentage of subjects achieved multiple lipid level (Total-C < 200mg/dL, LDL-C < 70mg/dL and triglyceride < 150mg /dL)
Baseline, Visit 4(Day 90)
Cardiovascular event rates including stroke (ischemic or hemorrhagic), coronary artery(myocardial infarction or coronary vascular reperfusion) and death related to vascular disease.
Time Frame: Baseline to Visit 4(up to 90 days)
Cardiovascular event rates including stroke (ischemic of hemorrhagic), coronary artery(myocardial infarction or coronary vascular reperfusion) and death related to vascular disease.
Baseline to Visit 4(up to 90 days)
Number of Death of all causes.
Time Frame: Baseline to Visit 4(up to 90 days)
Number of Death of all causes.
Baseline to Visit 4(up to 90 days)
Number of subjects with newly diagnosed diabetes.
Time Frame: Visit 4(Day 90)
Number of subjects with newly diagnosed diabetes.
Visit 4(Day 90)
Fatigue scale measured by Fatigue Severity Scale.
Time Frame: Screening, Visit 4(Day 90)
Fatigue scale measured by Fatigue Severity Scale. (The Fatigue Severity Scale is a 9-item scale which measures the severity of fatigue and its effect on a person's activity and lifestyle in patients with a variety of disorders. A 9-item questionnaire with questions related to how fatigue interferes with certain activities and rates its severity. The Fatigue Severity Scale scores range from 9 to 63, with higher scores indicating a greater fatigue severity.)
Screening, Visit 4(Day 90)
Incidence of rhabdomyolysis
Time Frame: Baseline to Visit 4(up to 90 days)
Incidence of rhabdomyolysis
Baseline to Visit 4(up to 90 days)
Incidence of serious liver dysfunction
Time Frame: Baseline to Visit 4(up to 90 days)
Incidence of serious liver dysfunction (AST or ALT increase more than three times from baseline)
Baseline to Visit 4(up to 90 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Keun-Sik Hong

Collaborators

Samsung Medical Center
Seoul St. Mary's Hospital
Seoul National University Hospital
Korea University Guro Hospital
Korea University
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Inje University
Severance Hospital
Hallym University Medical Center
Kyunghee University Medical Center
Myongji Hospital
Ewha Womans University Seoul Hospital

Investigators

  • Principal Investigator: Keun-Sik Hong, MD., PhD., Department of Neurology, Inje University Ilsan Paik Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2019

Primary Completion (Anticipated)

November 12, 2020

Study Completion (Anticipated)

November 12, 2020

Study Registration Dates

First Submitted

June 17, 2019

First Submitted That Met QC Criteria

June 19, 2019

First Posted (Actual)

June 20, 2019

Study Record Updates

Last Update Posted (Actual)

February 12, 2020

Last Update Submitted That Met QC Criteria

February 11, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROSETTA-Stroke

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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