search
Back to results

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

Primary Purpose

Stroke, Ischemic

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Experimental: Rosuvastatin/Ezetimibe 10
Active Comparator: Rosuvastatin 20mg
Sponsored by
Keun-Sik Hong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stroke, Ischemic focused on measuring Stroke, Ischemic, Rosuvastatin, Ezetimibe

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Korea University Ansan HospitalRecruiting
  • Hallym University Medical CenterRecruiting
  • Myongji HospitalRecruiting
  • Inje University Ilsan Paik HospitalRecruiting
  • Chung-Ang University Hopital
  • Ewha Womans University Seoul hospitalRecruiting
  • Korea University Guro HospitalRecruiting
  • Kyung-Hee University Medical CenterRecruiting
  • Samsung Medical Center, Sungkyunkwan University School of MedicineRecruiting
  • Seoul National University Hospital
  • Seoul St Mary's HospitalRecruiting
  • Severance Hospital, Yonsei University Health SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rosuvastatin/Ezetimibe 10/10mg

Rosuvastatin 20mg

Arm Description

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

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

Outcomes

Primary Outcome Measures

The percentage of subjects with LDL-C decreased more than 50% at 90days (±14 days) compared to Baseline
The percentage of subjects with LDL-C decreased more than 50% at 90days (±14 days) compared to Baseline

Secondary Outcome Measures

Percentage of subjects with LDL-C less than 70 mg/dL at 90 days(±14 days)
Percentage of subjects with LDL-C less than 70 mg/dL at 90 days(±14 days)
The percentage of subjects with LDL-C decreased more than or less than 70 mg/dL at 90 days(±14 days)
The percentage of subjects with LDL-C decreased more than or less than 70 mg/dL at 90 days(±14 days)
The decrement of LDL-C at 90 days (±14 days) compared to baseline LDL-C (absolute difference and change)
The decrement of LDL-C at 90 days (±14 days) compared to baseline LDL-C (absolute difference and change)
The percentage of subjects achieved multiple lipid level (Total-C < 200mg/dL, LDL-C < 70mg/dL and triglyceride < 150mg /dL)
The percentage of subjects achieved multiple lipid level (Total-C < 200mg/dL, LDL-C < 70mg/dL and triglyceride < 150mg /dL)
Cardiovascular event rates including stroke (ischemic or hemorrhagic), coronary artery(myocardial infarction or coronary vascular reperfusion) and death related to vascular disease.
Cardiovascular event rates including stroke (ischemic of hemorrhagic), coronary artery(myocardial infarction or coronary vascular reperfusion) and death related to vascular disease.
Number of Death of all causes.
Number of Death of all causes.
Number of subjects with newly diagnosed diabetes.
Number of subjects with newly diagnosed diabetes.
Fatigue scale measured by Fatigue Severity Scale.
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.)
Incidence of rhabdomyolysis
Incidence of rhabdomyolysis
Incidence of serious liver dysfunction
Incidence of serious liver dysfunction (AST or ALT increase more than three times from baseline)

Full Information

First Posted
June 17, 2019
Last Updated
February 11, 2020
Sponsor
Keun-Sik Hong
Collaborators
Ewha Womans University Seoul Hospital, Severance Hospital, Korea University, Korea University Guro Hospital, Myongji Hospital, Seoul St. Mary's Hospital, Samsung Medical Center, Seoul National University Hospital, Chung-Ang University Hosptial, Chung-Ang University College of Medicine, Hallym University Medical Center, Kyunghee University Medical Center, Inje University
search

1. Study Identification

Unique Protocol Identification Number
NCT03993236
Brief Title
Study on Rosuvastatin+Ezetimibe and Rosuvastatin for LDL-C Goal in Patients With Recent Ischemic Stroke
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 9, 2019 (Actual)
Primary Completion Date
November 12, 2020 (Anticipated)
Study Completion Date
November 12, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Keun-Sik Hong
Collaborators
Ewha Womans University Seoul Hospital, Severance Hospital, Korea University, Korea University Guro Hospital, Myongji Hospital, Seoul St. Mary's Hospital, Samsung Medical Center, Seoul National University Hospital, Chung-Ang University Hosptial, Chung-Ang University College of Medicine, Hallym University Medical Center, Kyunghee University Medical Center, Inje University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic
Keywords
Stroke, Ischemic, Rosuvastatin, Ezetimibe

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
584 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rosuvastatin/Ezetimibe 10/10mg
Arm Type
Experimental
Arm Description
The experimental group is orally administered with rosuvastatin 10 mg plus ezetimibe 10 mg combination once daily for 90 days.
Arm Title
Rosuvastatin 20mg
Arm Type
Active Comparator
Arm Description
The comparator group is orally administered with rosuvastatin 20 mg single agent once daily for 90 days
Intervention Type
Drug
Intervention Name(s)
Experimental: Rosuvastatin/Ezetimibe 10
Other Intervention Name(s)
Rosuzet tab 10/10 mg
Intervention Description
Rosuvastatin/Ezetimibe 10/10mg orally administered once daily for 90 days
Intervention Type
Drug
Intervention Name(s)
Active Comparator: Rosuvastatin 20mg
Other Intervention Name(s)
Suvast tab 20mg
Intervention Description
Rosuvastatin 20mg orally administered once daily for 90 days
Primary Outcome Measure Information:
Title
The percentage of subjects with LDL-C decreased more than 50% at 90days (±14 days) compared to Baseline
Description
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)
Secondary Outcome Measure Information:
Title
Percentage of subjects with LDL-C less than 70 mg/dL at 90 days(±14 days)
Description
Percentage of subjects with LDL-C less than 70 mg/dL at 90 days(±14 days)
Time Frame
Baseline, Visit 4(Day 90)
Title
The percentage of subjects with LDL-C decreased more than or less than 70 mg/dL at 90 days(±14 days)
Description
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)
Title
The decrement of LDL-C at 90 days (±14 days) compared to baseline LDL-C (absolute difference and change)
Description
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)
Title
The percentage of subjects achieved multiple lipid level (Total-C < 200mg/dL, LDL-C < 70mg/dL and triglyceride < 150mg /dL)
Description
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)
Title
Cardiovascular event rates including stroke (ischemic or hemorrhagic), coronary artery(myocardial infarction or coronary vascular reperfusion) and death related to vascular disease.
Description
Cardiovascular event rates including stroke (ischemic of 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)
Title
Number of Death of all causes.
Description
Number of Death of all causes.
Time Frame
Baseline to Visit 4(up to 90 days)
Title
Number of subjects with newly diagnosed diabetes.
Description
Number of subjects with newly diagnosed diabetes.
Time Frame
Visit 4(Day 90)
Title
Fatigue scale measured by Fatigue Severity Scale.
Description
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.)
Time Frame
Screening, Visit 4(Day 90)
Title
Incidence of rhabdomyolysis
Description
Incidence of rhabdomyolysis
Time Frame
Baseline to Visit 4(up to 90 days)
Title
Incidence of serious liver dysfunction
Description
Incidence of serious liver dysfunction (AST or ALT increase more than three times from baseline)
Time Frame
Baseline to Visit 4(up to 90 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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: Patients who sustained stroke symptoms for more than 24 hours and had acute ischemic lesions on DWI. Patients with acute ischemic lesions in DWI who had improved symptoms within 24 hours. 2) Patients with ischemic stroke within 90 days. 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: Patients with ischemic stroke due to arteriosclerosis and LDL-C ≥ 100 mg / dL. (Class I; Level of Evidence B) Patients with ischemic stroke due to arteriosclerosis and LDL-C <100 mg / dL. (Class I; Level of Evidence C) Patients who require statin therapy due to other associated atherosclerotic cardiovascular disease. (Class I; Level of Evidence A). Patients without statin dose within 28 days before ischemic stroke. Patients who measured baseline LDL-C levels after an ischemic stroke. This is satisfied by meeting at least one of the following two criteria: Patients who had a baseline LDL-C level before the onset of a recent ischemic stroke and started statin therapy. Patients hospitalized with acute ischemic stroke who had baseline LDL-C levels after initiation of statin therapy should meet both of the following conditions: Patients with LDL-C levels measured within 3 days after initiation of statin therapy Patients in whom randomization and administration of the study drug can be administered within 7 days after baseline LDL-C measurement. Adults over 19 years. Those who voluntarily agreed in writing to the trial. Exclusion Criteria: Planned vascular intervention before the end of trial Significant hepatic dysfunction (Aspartate Aminotransferase or Alanine Aminotransferase >120 IU/L) Allergy or contraindication to rosuvastatin or ezetimibe Alcohol or drug addiction Pregnancy or breast-feeding Severe anemia: Hb level <10 g/dL for men and <9 g/dL for women Bleeding diathesis: platelet count <100,000/μl or prothrombin time International Normalized Ratio > 1·7 Inability or unwillingness to comply with study-related procedures Employees of the investigator or study center, with direct involvement in the current study Women unwilling to continue contraception during the study period Participation in other clinical trials within three-month Malignancy or other serious medical conditions with a life expectancy <6 months Treatment with protease inhibitors or cyclosporine Patients with severe renal impairment (creatinine clearance <30 mL / min) Other reasons for ineligibility judged by investigators
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Keun-Sik Hong, MD., PhD.
Phone
82-31-910-7277
Email
nrhks@paik.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keun-Sik Hong, MD., PhD.
Organizational Affiliation
Department of Neurology, Inje University Ilsan Paik Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Ansan Hospital
City
Ansan-Si
State/Province
Gyeonggi-Do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin-Man Jung, MD., PhD.
Email
sodium75@hanmail.net
Facility Name
Hallym University Medical Center
City
Anyang-si
State/Province
Gyeonggi-Do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mi-Sun Oh, MD., PhD.
Email
iyyar@hallym.ac.kr
Facility Name
Myongji Hospital
City
Goyang-Si
State/Province
Gyeonggi-Do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jong-Ho Park, MD., PhD.
Email
neurocraft.jhp@gmail.com
Facility Name
Inje University Ilsan Paik Hospital
City
Ilsan
State/Province
Gyeonggi-Do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keun-Sik Hong, MD, Phd
Phone
82-31-910-7277
Email
nrhks@paik.ac.kr
Facility Name
Chung-Ang University Hopital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kwang-Yeol Park, MD., PhD.
Email
sbaram1@cau.ac.kr
Facility Name
Ewha Womans University Seoul hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tae-Jin Song, MD., PhD.
Email
knstar@hanmail.net
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chi-Kyung Kim, MD., PhD.
Email
ckkim7@korea.ac.kr
Facility Name
Kyung-Hee University Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung-Hyuk Heo, MD., PhD.
Email
shheo73@khu.ac.kr
Facility Name
Samsung Medical Center, Sungkyunkwan University School of Medicine
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oh-Young Bang, MD., PhD.
Email
ohyoung.bang@samsung.com
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tae-Jung Kim, MD.,PhD.
Email
ttae35@gmail.com
Facility Name
Seoul St Mary's Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ja-Seong Koo, MD., PhD.
Email
carotidstroke@gmail.com
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyo-Suk Nam, MD., PhD.
Email
hsnam@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs