DyslipidemiasPhase 4NCT05884502
A Multicenter Study to Evaluate the Effect of High Dose Rosuvastatin Versus Rosuvastatin and Ezetimibe in Stroke
A Phase 4 study testing combination of high-dose rosuvastatin and ezetimibe and high-dose rosuvastatin single administration in people with Dyslipidemias and Stroke, Acute Ischemic, run by Korea University Anam Hospital at 3 sites in South Korea.
Trial summary
High-intensity statins are recommended for secondary prevention of stroke in patients with atherosclerotic ischemic stroke. According to the guidelines of the American Heart Association and the American Stroke Society, high-intensity or high-dose statins are recommended for high-risk groups of atherosclerotic… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Dyslipidemias, Stroke, Acute Ischemic
- What is being tested?
- combination of high-dose rosuvastatin and ezetimibe and high-dose rosuvastatin single administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 1 Sep 2022to 31 Dec 2024
- 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
- Those with primary hypercholesterolemia among those whose lesions were confirmed by brain CT or MRI within 48 hours of the onset of ischemic stroke
- Adults 19 years of age or older
- Patients who agreed to participate in this study
Who cannot join
- Patients scheduled for carotid endarterectomy or stenting, cerebral artery stenting, coronary angioplasty and stenting, or coronary artery bypass surgery within 3 months
- Patients with malignant tumors that have not been cured
- Patients who have participated in other drug clinical trials within the last 30 days
- Patients expected to experience side effects when taking rosuvastatin and ezetimibe
- Patients who did not consent to participate in this study
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites, 3 recruiting
- Recruiting
Korea University Ansan Hospital
Ansan, Gyeonggi-do, 15355
Jin-Man Jung, M.D., sodium75@hanmail.net
- Recruiting
Korea University Anam Hospital
Seoul, 02841
Sungwook Yu, M.D., 82-2-920-5510, song4yu@korea.ac.kr
- Recruiting
Koera University Guro Hospital
Seoul, 08308
Chi-Kyung Kim, M.D., ckkim7@gmail.com
About this study
Official title: A Multicenter Prospective Randomized-controlled Interventional Study to Evaluate the Effect of High Dose Rosuvastatin Versus High Dose Rosuvastatin and Ezetimibe in Acute Ischemic Stroke Patients
High-intensity statins are recommended for secondary prevention of stroke in patients with atherosclerotic ischemic stroke. According to the guidelines of the American Heart Association and the American Stroke Society, high-intensity or high-dose statins are recommended for high-risk groups of atherosclerotic cardiovascular disease (ASCVD). Statin therapy is recommended even if it is less than 100 mg/dL. The 2016 ESC/EAS and 2017 AACE guidelines include ischemic stroke and transient cerebral ischemic attacks caused by atherosclerosis in ASCVD, classifying them as ultra-high-risk groups, and recommending LDL cholesterol of less than 70 mg/dL as a treatment goal. The recently published guidelines for dyslipidemia in Korea also recommend that the target level of LDL cholesterol in patients with atherosclerotic ischemic stroke and transient ischemic attack be reduced to less than 70 mg/dL or 50% or more from the baseline.
According to a previous study on the efficacy and safety of high-intensity rosuvastatin in patients with ischemic stroke, it is not clear whether the use of rosuvastatin 20 mg prevents recurrence of cerebral infarction in the acute stage, but it is safe and effective for hemorrhagic conversion of cerebral infarction. In addition, the results were shown when rosuvastatin and ezetimibe were combined in patients with high cardiovascular risk, LDL cholesterol and total cholesterol decreased more in the combined group than in the single agent group. In a study comparing the group whose LDL cholesterol target was reduced to 70 mg/dL or less after stroke and the group maintained at 90-110 mg/dL, the group whose LDL cholesterol was controlled to 70 mg/dL or less It was confirmed that the incidence of cardiovascular disease was reduced. Existing studies aimed at general high-risk groups, not specific disease groups, and as in this study, studies were not conducted on a single disease group called acute stroke. In addition, there are only limited studies on the effectiveness and safety of diseases that occur mainly in the elderly, such as acute stroke. Therefore, there are currently no studies on the clinical efficacy and safety of high-intensity rosuvastatin and ezetimibe combination therapy for patients with acute cerebral infarction.
Read the detailed description
Multicenter, randomized controlled trial to compare the efficacy and safety of the test group (high-dose rosuvastatin and ezetimibe combined administration group) and control group (high-dose rosuvastatin single administration group) to achieve the target LDL-C level in patients who have recently experienced an ischemic stroke; It is an open-label, investigator-led clinical trial.
In this clinical trial, treatment is performed according to the general treatment procedure for patients who have recently had an ischemic stroke. Subjects who agree to participate in the clinical trial and satisfy the selection and exclusion criteria are the test group (combination of high-dose rosuvastatin and ezetimibe). Administration group) and control group (high-dose rosuvastatin single administration group) are randomly assigned in a 1:1 ratio.
Clinical investigational drugs according to randomization are administered to hospitalized patients, and when discharged, they are allowed to take the provided clinical investigational drugs for a total of 90 days. After the baseline, on the 7th day or at discharge (1st follow-up), and on the 30th day (2nd follow-up), compliance with medication and occurrence of adverse reactions are observed, and on the 90th day (3rd follow-up), lipid concentration test is performed. Check LDL-C levels and compare with baseline LDL-C levels.
- Conditions
- Dyslipidemias, Stroke, Acute Ischemic
- Being tested
- combination of high-dose rosuvastatin and ezetimibe, high-dose rosuvastatin single administration
- Medical subject headings
- Dyslipidemias, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combination of high-dose rosuvastatin and ezetimibeDrug
combination of rosuvastatin 20mg and ezetimibe 10mg
high-dose rosuvastatin single administrationDrug
rosuvastatin 20mg monotherapy
| Study group | Role | What they receive |
|---|---|---|
| Combination therapy | Experimental | combination of high-dose rosuvastatin and ezetimibe Receives: Drug: combination of high-dose rosuvastatin and ezetimibe |
| Single therapy | Active comparator | high-dose rosuvastatin single administration group Receives: Drug: high-dose rosuvastatin single administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute value of LDL-C (low-density lipoprotein cholesterol) reduction
low-density lipoprotein cholesterol reduction at 90 days after enrollment
Measured: 90 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start1 Sep 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multicenter prospective randomized-controlled
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu, Sungwook, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884502
- Sponsor's protocol ID
- 2021AN0073
- Status last verified
- May 2023
- First submitted
- 10 Apr 2023
- Last updated
- 1 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Randomized-controlled Interventional Study to Evaluate the Effect of High Dose Rosuvastatin Versus High Dose Rosuvastatin and Ezetimibe in Acute Ischemic Stroke Patients
- ClinicalTrials.gov ID
- NCT05884502
- Acronym / sponsor ID
- 2021AN0073
- Conditions
- Dyslipidemias, Stroke, Acute Ischemic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
High-intensity statins are recommended for secondary prevention of stroke in patients with atherosclerotic ischemic stroke. According to the guidelines of the American Heart Association and the American Stroke Society, high-intensity or high-dose statins are recommended for high-risk groups of atherosclerotic cardiovascular disease (ASCVD). Statin therapy is recommended even if it is less than 100 mg/dL. The 2016 ESC/EAS and 2017 AACE guidelines include ischemic stroke and transient cerebral ischemic attacks caused by atherosclerosis in ASCVD, classifying them as ultra-high-risk groups, and recommending LDL cholesterol of less than 70 mg/dL as a treatment goal. The recently published guidelines for dyslipidemia in Korea also recommend that the target level of LDL cholesterol in patients with atherosclerotic ischemic stroke and transient ischemic attack be reduced to less than 70 mg/dL or 50% or more from the baseline.
According to a previous study on the efficacy and safety of high-intensity rosuvastatin in patients with ischemic stroke, it is not clear whether the use of rosuvastatin 20 mg prevents recurrence of cerebral infarction in the acute stage, but it is safe and effective for hemorrhagic conversion of cerebral infarction. In addition, the results were shown when rosuvastatin and ezetimibe were combined in patients with high cardiovascular risk, LDL cholesterol and total cholesterol decreased more in the combined group than in the single agent group. In a study comparing the group whose LDL cholesterol target was reduced to 70 mg/dL or less after stroke and the group maintained at 90-110 mg/dL, the group whose LDL cholesterol was controlled to 70 mg/dL or less It was confirmed that the incidence of cardiovascular disease was reduced. Existing studies aimed at general high-risk groups, not specific disease groups, and as in this study, studies were not conducted on a single disease group called acute stroke. In addition, there are only limited studies on the effectiveness and safety of diseases that occur mainly in the elderly, such as acute stroke. Therefore, there are currently no studies on the clinical efficacy and safety of high-intensity rosuvastatin and ezetimibe combination therapy for patients with acute cerebral infarction.
Detailed description
Multicenter, randomized controlled trial to compare the efficacy and safety of the test group (high-dose rosuvastatin and ezetimibe combined administration group) and control group (high-dose rosuvastatin single administration group) to achieve the target LDL-C level in patients who have recently experienced an ischemic stroke; It is an open-label, investigator-led clinical trial.
In this clinical trial, treatment is performed according to the general treatment procedure for patients who have recently had an ischemic stroke. Subjects who agree to participate in the clinical trial and satisfy the selection and exclusion criteria are the test group (combination of high-dose rosuvastatin and ezetimibe). Administration group) and control group (high-dose rosuvastatin single administration group) are randomly assigned in a 1:1 ratio.
Clinical investigational drugs according to randomization are administered to hospitalized patients, and when discharged, they are allowed to take the provided clinical investigational drugs for a total of 90 days. After the baseline, on the 7th day or at discharge (1st follow-up), and on the 30th day (2nd follow-up), compliance with medication and occurrence of adverse reactions are observed, and on the 90th day (3rd follow-up), lipid concentration test is performed. Check LDL-C levels and compare with baseline LDL-C levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- multicenter prospective randomized-controlled
| Arm | Type | Receives |
|---|---|---|
| Combination therapy | Experimental | Drug: combination of high-dose rosuvastatin and ezetimibecombination of high-dose rosuvastatin and ezetimibe |
| Single therapy | Active comparator | Drug: high-dose rosuvastatin single administrationhigh-dose rosuvastatin single administration group |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Those with primary hypercholesterolemia among those whose lesions were confirmed by brain CT or MRI within 48 hours of the onset of ischemic stroke
- Adults 19 years of age or older
- Patients who agreed to participate in this study
Key exclusion criteria (5 listed)
- Patients scheduled for carotid endarterectomy or stenting, cerebral artery stenting, coronary angioplasty and stenting, or coronary artery bypass surgery within 3 months
- Patients with malignant tumors that have not been cured
- Patients who have participated in other drug clinical trials within the last 30 days
- Patients expected to experience side effects when taking rosuvastatin and ezetimibe
- Patients who did not consent to participate in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| combination of high-dose rosuvastatin and ezetimibecombination of rosuvastatin 20mg and ezetimibe 10mg | Drug | Combination therapy |
| high-dose rosuvastatin single administrationrosuvastatin 20mg monotherapy | Drug | Single therapy |
Primary outcome
Absolute value of LDL-C (low-density lipoprotein cholesterol) reduction
Time frame: 90 days after enrollment
low-density lipoprotein cholesterol reduction at 90 days after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing combination of high-dose rosuvastatin and ezetimibe and high-dose rosuvastatin single administration in people with Dyslipidemias and Stroke, Acute Ischemic, run by Korea University Anam Hospital at 3 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sungwook Yu, M.D. (82-2-920-5510, song4yu@korea.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute value of LDL-C (low-density lipoprotein cholesterol) reduction (time frame: 90 days after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2023.