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

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ClinicalTrials.gov Identifier: NCT03993236
Recruitment Status : Not yet recruiting
First Posted : June 20, 2019
Last Update Posted : June 20, 2019
Sponsor:
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
Information provided by (Responsible Party):
Keun-Sik Hong, Inje University

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

Condition or disease Intervention/treatment Phase
Stroke, Ischemic Drug: Experimental: Rosuvastatin/Ezetimibe 10 Drug: Active Comparator: Rosuvastatin 20mg Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 584 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Estimated Study Start Date : July 22, 2019
Estimated Primary Completion Date : November 12, 2020
Estimated Study Completion Date : November 12, 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Suvast tab 20mg




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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.

  6. Number of Death of all causes. [ Time Frame: Baseline to Visit 4(up to 90 days) ]
    Number of Death of all causes.

  7. Number of subjects with newly diagnosed diabetes. [ Time Frame: Visit 4(Day 90) ]
    Number of subjects with newly diagnosed diabetes.

  8. 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.)

  9. Incidence of rhabdomyolysis [ Time Frame: Baseline to Visit 4(up to 90 days) ]
    Incidence of rhabdomyolysis

  10. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03993236


Contacts
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Contact: Keun-Sik Hong, MD., PhD. 82-31-910-7277 nrhks@paik.ac.kr

Locations
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Korea, Republic of
Korea University Ansan Hospital Not yet recruiting
Ansan-Si, Gyeonggi-Do, Korea, Republic of
Contact: Jin-Man Jung, MD., PhD.       sodium75@hanmail.net   
Hallym University Medical Center Not yet recruiting
Anyang-si, Gyeonggi-Do, Korea, Republic of
Contact: Mi-Sun Oh, MD., PhD.       iyyar@hallym.ac.kr   
Myongji Hospital
Goyang-Si, Gyeonggi-Do, Korea, Republic of
Inje University Ilsan Paik Hospital Not yet recruiting
Ilsan, Gyeonggi-Do, Korea, Republic of
Contact: Keun-Sik Hong, MD, Phd    82-31-910-7277    nrhks@paik.ac.kr   
Chung-Ang University Hopital Not yet recruiting
Seoul, Korea, Republic of
Contact: Kwang-Yeol Park, MD., PhD.       sbaram1@cau.ac.kr   
Ewha Womans University Seoul hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Tae-Jin Song, MD., PhD.       knstar@hanmail.net   
Korea University Guro Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Chi-Kyung Kim, MD., PhD.       ckkim7@korea.ac.kr   
Kyung-Hee University Medical Center Not yet recruiting
Seoul, Korea, Republic of
Contact: Sung-Hyuk Heo, MD., PhD.       shheo73@khu.ac.kr   
Samsung Medical Center, Sungkyunkwan University School of Medicine Not yet recruiting
Seoul, Korea, Republic of
Contact: Oh-Young Bang, MD., PhD.       ohyoung.bang@samsung.com   
Seoul National University Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Sang-Bae Ko, MD.,PhD.       sangbai1378@gmail.com   
Seoul St Mary's Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Ja-Seong Koo, MD., PhD.       carotidstroke@gmail.com   
Severance Hospital, Yonsei University Health System Not yet recruiting
Seoul, Korea, Republic of
Contact: Hyo-Suk Nam, MD., PhD.       hsnam@yuhs.ac   
Sponsors and Collaborators
Keun-Sik Hong
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
Investigators
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Principal Investigator: Keun-Sik Hong, MD., PhD. Department of Neurology, Inje University Ilsan Paik Hospital

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Responsible Party: Keun-Sik Hong, Principal Investigator, Inje University
ClinicalTrials.gov Identifier: NCT03993236     History of Changes
Other Study ID Numbers: ROSETTA-Stroke
First Posted: June 20, 2019    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Keun-Sik Hong, Inje University:
Stroke, Ischemic
Rosuvastatin
Ezetimibe
Additional relevant MeSH terms:
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Stroke
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Rosuvastatin Calcium
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors