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Stroke, IschemicPhase 4NCT03993236

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

A Phase 4 study testing Experimental: Rosuvastatin/Ezetimibe 10 and Active Comparator: Rosuvastatin 20mg in people with Stroke, Ischemic, run by Keun-Sik Hong at 12 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Stroke, Ischemic
What is being tested?
Experimental: Rosuvastatin/Ezetimibe 10 and Active Comparator: Rosuvastatin 20mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
584 participants
Where
12 sitesSouth Korea
Study dates
9 Sep 2019to 27 Sep 2021
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

South Korea12 sites

  • Korea University Ansan Hospital

    Ansan-si, Gyeonggi-do

  • Hallym University Medical Center

    Anyang-si, Gyeonggi-do

  • Myongji Hospital

    Goyang-si, Gyeonggi-do

  • Inje University Ilsan Paik Hospital

    Ilsan, Gyeonggi-do

  • Chung-Ang University Hopital

    Seoul

  • Ewha Womans University Seoul hospital

    Seoul

  • Korea University Guro Hospital

    Seoul

  • Kyung-Hee University Medical Center

    Seoul

  • Samsung Medical Center, Sungkyunkwan University School of Medicine

    Seoul

  • Seoul National University Hospital

    Seoul

  • Seoul St Mary's Hospital

    Seoul

  • Severance Hospital, Yonsei University Health System

    Seoul

Other trials in South Korea

About this study

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

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

Read the 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.

Being tested
Experimental: Rosuvastatin/Ezetimibe 10, Active Comparator: Rosuvastatin 20mg
Keywords
Stroke, Ischemic, Rosuvastatin, Ezetimibe
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental: Rosuvastatin/Ezetimibe 10Drug

    Also called Rosuzet tab 10/10 mg

    • Rosuvastatin/Ezetimibe 10/10mg
    • orally administered once daily for 90 days

  • Active Comparator: Rosuvastatin 20mgDrug

    Also called Suvast tab 20mg

    • Rosuvastatin 20mg
    • orally administered once daily for 90 days
Study groups in NCT03993236
Study groupRoleWhat they receive
Rosuvastatin/Ezetimibe 10/10mgExperimentalThe experimental group is orally administered with rosuvastatin 10 mg plus ezetimibe 10 mg combination once daily for 90 days.
Receives: Drug: Experimental: Rosuvastatin/Ezetimibe 10
Rosuvastatin 20mgActive comparatorThe comparator group is orally administered with rosuvastatin 20 mg single agent once daily for 90 days
Receives: Drug: Active Comparator: Rosuvastatin 20mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline, Visit 4(Day 90)

Secondary outcomes (10)

  1. 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)

    Measured: Baseline, Visit 4(Day 90)

  2. 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)

    Measured: Baseline, Visit 4(Day 90)

  3. 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)

    Measured: Baseline, Visit 4(Day 90)

  4. 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)

    Measured: Baseline, Visit 4(Day 90)

  5. 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.

    Measured: Baseline to Visit 4(up to 90 days)

  6. Number of Death of all causes.

    Number of Death of all causes.

    Measured: Baseline to Visit 4(up to 90 days)

  7. Number of subjects with newly diagnosed diabetes.

    Number of subjects with newly diagnosed diabetes.

    Measured: Visit 4(Day 90)

  8. 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.)

    Measured: Screening, Visit 4(Day 90)

  9. Incidence of rhabdomyolysis

    Incidence of rhabdomyolysis

    Measured: Baseline to Visit 4(up to 90 days)

  10. Incidence of serious liver dysfunction

    Incidence of serious liver dysfunction (AST or ALT increase more than three times from baseline)

    Measured: Baseline to Visit 4(up to 90 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2019
  2. Study start9 Sep 2019
  3. Primary completion27 Sep 2021
  4. Study completion27 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
584 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03993236
Sponsor's protocol ID
ROSETTA-Stroke
Status last verified
Oct 2024
First submitted
17 Jun 2019
Last updated
3 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hong KS, Bang OY, Park JH, Jung JM, Lee SH, Song TJ, Nam HS, Park HK, Jung KH, Heo SH, Koo J, Yu KH, Park KY, Kim CK, Park HK, Lee J, Lee J, Seo WK. Moderate-Intensity Rosuvastatin Plus Ezetimibe Versus High-Intensity Rosuvastatin for Target Low-Density Lipoprotein Cholesterol Goal Achievement in Patients With Recent Ischemic Stroke: A Randomized Controlled Trial. J Stroke. 2023 May;25(2):242-250. doi: 10.5853/jos.2022.02957. Epub 2023 Apr 11.

    PubMed 37032475

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Experimental: Rosuvastatin/Ezetimibe 10 and Active Comparator: Rosuvastatin 20mg in people with Stroke, Ischemic, run by Keun-Sik Hong at 12 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03993236, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.

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