Acute Ischemic StrokeNCT06134635
Short-term Effect of PCSK9 Inhibitor in Patients With Acute Ischemic Stroke
An observational study of Acute Ischemic Stroke, run by Xuanwu Hospital, Beijing.
Trial summary
This is a prospective cohort study to investigate the early impact of evolocumab on patients with acute ischemic stroke (AIS) in China. Evolocumab, a proprotein convertase subtilisin/kexin taye 9 inhibitor, can significantly reduce low density lipoprotein cholesterol (LDL-C) levels and has a positive effect on… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Statins and Evolocumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 1 Dec 2024
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute ischemic stroke patients aged 18 to 80 years
Who may be able to join
- Diagnosed with acute ischemic stroke;
- Aged 18-80 years, gender unlimited;
- The fasting LDL-C≥1.8mmol/L (70mg/dL);
- Received lipid-lowering therapy with statins with or without evolocumab;
- Premorbid mRS ≤ 2;
- NIHSS ≤ 15;
- Subjects participated in the study voluntarily and signed informed consent.
Who cannot join
- Participants who changed their lipid-lowering regimen;
- Participants allergic to PCSK9 inhibitors;
- Participants treated with cholesterol ester transfer protein inhibitor within 12 months prior to enrollment;
- LDL or plasma apheresis within 12 months prior to enrollment；
- Last known left ventricular ejection fraction < 30%
- Known hemorrhagic stroke at any time；
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- Severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73m2 at final screening；
- Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times；
- Pregnant or lactating women；
- Severe, concomitant non-cardiovascular disease that is expected to reduce life expectancy to less than 3 years.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Short-term Effect of Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor in Chinese Population With Acute Ischemic Stroke: the Singe-center Real-world Study
This is a prospective cohort study to investigate the early impact of evolocumab on patients with acute ischemic stroke (AIS) in China. Evolocumab, a proprotein convertase subtilisin/kexin taye 9 inhibitor, can significantly reduce low density lipoprotein cholesterol (LDL-C) levels and has a positive effect on improving cardiovascular events. However, existing studies have focused almost exclusively on the long-term effects of Evolocumab, and the early effects of Evolocumab on AIS patients remains unclear.
Read the detailed description
Patients aged 18-80 years old admitted to the Department of Neurology, Xuanwu Hospital, Capital Medical University, with a definite diagnosis of acute ischemic stroke and receiving lipid-lowering therapy with statins with or without evolocumab will be included in this study. Participants will be divided into two groups according to the lipid-lowering therapy they used: 1) statin-alone group: the participants receive statins alone (atorvastatin 20mg qn or rosuvastatin 10mg qn or pivastatin 2mg qn) for lipid reduction, and 2) PCSK9-i group: the participants receive statins (atorvastatin 20mg qn or rosuvastatin 10mg qn or pivastatin 2mg qn) and evolocumab (140mg twice a month) for lipid reduction. Most importantly, the lipid-lowering therapy of participants will be decided only by clinicians not involved in the study, not by the investigators. The levels of blood lipid (TC, TG, HDL-C, LDL-C, Apo AI and Apo B) and inflammatory biomarkers (hsCRP and IL-6) of these participants at different time points (day 1, day 3, day 5, and month 3) will be recorded. The target level of LDL-C is the LDL-C reduction ≥50% from the baseline and LDL-C<1.4mmol/L (55mg/dL). In addition, the cardiovascular events and adverse drug reactions of these participants during follow-up will also be recorded. During the follow-up period (3 months), participants who changed their lipid-lowering regimen, including the type, dosage and frequency of statins and evolocumab, will be excluded from the study.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Statins, Evolocumab
- Keywords
- Acute Ischemic Stroke, Evolocumab, PCSK9 Inhibitor, Statins
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StatinsDrug
Also called statin therapy
Atorvastatin 20mg qn or rosuvastatin 10mg qn or pivastatin 2mg qn, oral
EvolocumabDrug
Also called PCSK9-i
Evolocumab 140mg twice a month, subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Statin-alone group | The participants in statin-alone group receive statins alone for lipid reduction. Receives: Drug: Statins | |
| PCSK9-i group | The participants in PCSK9-i group receive statins and evolocumab for lipid reduction. Receives: Drug: Statins; Drug: Evolocumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-C target achievement rate on Day 5, Month 3
LDL-C target achievement rate= Number of patients who achieved the LDL-C target level/ Total number of follow-up patients
Measured: Day 5, Month 3
Secondary outcomes (11)
Percentage change in LDL-C level on Day 1, Day 3, Day 5, and Month 3
Percentage change in LDL-C level= (follow-up LDL-C level - baseline LDL-C level)/ baseline LDL-C level
Measured: Day 1, Day 3, Day 5, Month 3
Percentage change in HDL-C level on Day 1, Day 3, Day 5, and Month 3
Percentage change in HDL-C level= (follow-up HDL-C level - baseline HDL-C level)/ baseline HDL-C level
Measured: Day 1, Day 3, Day 5, Month 3
Percentage change in TC level on Day 1, Day 3, Day 5, and Month 3
Percentage change in TC level= (follow-up TC level - baseline TC level)/ baseline TC level
Measured: Day 1, Day 3, Day 5, Month 3
Percentage change in TG level on Day 1, Day 3, Day 5, and Month 3
Percentage change in TG level= (follow-up TG level - baseline TG level)/ baseline TG level
Measured: Day 1, Day 3, Day 5, Month 3
Percentage change in Apo AI level on Day 1, Day 3, Day 5, and Month 3
Percentage change in Apo AI level= (follow-up Apo AI level - baseline Apo AI level)/ baseline Apo AI level
Measured: Day 1, Day 3, Day 5, Month 3
Percentage change in Apo B level on Day 1, Day 3, Day 5, and Month 3
Percentage change in Apo B level= (follow-up Apo B level - baseline Apo B level)/ baseline Apo B level
Measured: Day 1, Day 3, Day 5, Month 3
Percentage change in hsCRP level on Day 1, Day 3, Day 5, and Month 3
Percentage change in hsCRP level= (follow-up hsCRP level - baseline hsCRP level)/ baseline hsCRP level
Measured: Day 1, Day 3, Day 5, Month 3
Percentage change in IL-6 level on Day 1, Day 3, Day 5, and Month 3
Percentage change in IL-6 level= (follow-up IL-6 level - baseline IL-6 level)/ baseline IL-6 level
Measured: Day 1, Day 3, Day 5, Month 3
Percentage of mRS≤2 on Month 3
Percentage of mRS≤2= Number of patients with mRS≤2/ Total number of follow-up patients
Measured: Month 3
Incidence of major cardiovascular events on Month 3
Major cardiovascular events: stroke, cardiovascular death, myocardial infarction, hospitalization for unstable angina, and coronary revascularization.
Measured: Month 3
Incidence of adverse events on Month 3
Adverse events: injection site reaction, anaphylaxis, myopathy, abnormal liver function, new onset diabetes, cognitive impairment, and hemorrhagic cerebral infarction.
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meng Ran, PhD, Study chair, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06134635
- Sponsor's protocol ID
- RMeng
- Status last verified
- Oct 2023
- First submitted
- 24 Oct 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effect of Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor in Chinese Population With Acute Ischemic Stroke: the Singe-center Real-world Study
- ClinicalTrials.gov ID
- NCT06134635
- Acronym / sponsor ID
- RMeng
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute Ischemic Stroke, Evolocumab, PCSK9 Inhibitor, Statins
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 18 Nov 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.
This is a prospective cohort study to investigate the early impact of evolocumab on patients with acute ischemic stroke (AIS) in China. Evolocumab, a proprotein convertase subtilisin/kexin taye 9 inhibitor, can significantly reduce low density lipoprotein cholesterol (LDL-C) levels and has a positive effect on improving cardiovascular events. However, existing studies have focused almost exclusively on the long-term effects of Evolocumab, and the early effects of Evolocumab on AIS patients remains unclear.
Detailed description
Patients aged 18-80 years old admitted to the Department of Neurology, Xuanwu Hospital, Capital Medical University, with a definite diagnosis of acute ischemic stroke and receiving lipid-lowering therapy with statins with or without evolocumab will be included in this study. Participants will be divided into two groups according to the lipid-lowering therapy they used: 1) statin-alone group: the participants receive statins alone (atorvastatin 20mg qn or rosuvastatin 10mg qn or pivastatin 2mg qn) for lipid reduction, and 2) PCSK9-i group: the participants receive statins (atorvastatin 20mg qn or rosuvastatin 10mg qn or pivastatin 2mg qn) and evolocumab (140mg twice a month) for lipid reduction. Most importantly, the lipid-lowering therapy of participants will be decided only by clinicians not involved in the study, not by the investigators. The levels of blood lipid (TC, TG, HDL-C, LDL-C, Apo AI and Apo B) and inflammatory biomarkers (hsCRP and IL-6) of these participants at different time points (day 1, day 3, day 5, and month 3) will be recorded. The target level of LDL-C is the LDL-C reduction ≥50% from the baseline and LDL-C<1.4mmol/L (55mg/dL). In addition, the cardiovascular events and adverse drug reactions of these participants during follow-up will also be recorded. During the follow-up period (3 months), participants who changed their lipid-lowering regimen, including the type, dosage and frequency of statins and evolocumab, will be excluded from the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Statin-alone group | – | Drug: StatinsThe participants in statin-alone group receive statins alone for lipid reduction. |
| PCSK9-i group | – | Drug: Statins, Drug: EvolocumabThe participants in PCSK9-i group receive statins and evolocumab for lipid reduction. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute ischemic stroke patients aged 18 to 80 years
Key inclusion criteria (7 listed)
- Diagnosed with acute ischemic stroke;
- Aged 18-80 years, gender unlimited;
- The fasting LDL-C≥1.8mmol/L (70mg/dL);
- Received lipid-lowering therapy with statins with or without evolocumab;
- Premorbid mRS ≤ 2;
Key exclusion criteria (10 listed)
- Participants who changed their lipid-lowering regimen;
- Participants allergic to PCSK9 inhibitors;
- Participants treated with cholesterol ester transfer protein inhibitor within 12 months prior to enrollment;
- LDL or plasma apheresis within 12 months prior to enrollment；
- Last known left ventricular ejection fraction < 30%
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 |
|---|---|---|
| StatinsAlso: statin therapyAtorvastatin 20mg qn or rosuvastatin 10mg qn or pivastatin 2mg qn, oral | Drug | PCSK9-i group, Statin-alone group |
| EvolocumabAlso: PCSK9-iEvolocumab 140mg twice a month, subcutaneous injection | Drug | PCSK9-i group |
Primary outcome
LDL-C target achievement rate on Day 5, Month 3
Time frame: Day 5, Month 3
LDL-C target achievement rate= Number of patients who achieved the LDL-C target level/ Total number of follow-up patients
11 secondary outcomes
Percentage change in LDL-C level on Day 1, Day 3, Day 5, and Month 3
Time frame: Day 1, Day 3, Day 5, Month 3
Percentage change in HDL-C level on Day 1, Day 3, Day 5, and Month 3
Time frame: Day 1, Day 3, Day 5, Month 3
Percentage change in TC level on Day 1, Day 3, Day 5, and Month 3
Time frame: Day 1, Day 3, Day 5, Month 3
Percentage change in TG level on Day 1, Day 3, Day 5, and Month 3
Time frame: Day 1, Day 3, Day 5, Month 3
Percentage change in Apo AI level on Day 1, Day 3, Day 5, and Month 3
Time frame: Day 1, Day 3, Day 5, Month 3
Percentage change in Apo B level on Day 1, Day 3, Day 5, and Month 3
Time frame: Day 1, Day 3, Day 5, Month 3
Percentage change in hsCRP level on Day 1, Day 3, Day 5, and Month 3
Time frame: Day 1, Day 3, Day 5, Month 3
Percentage change in IL-6 level on Day 1, Day 3, Day 5, and Month 3
Time frame: Day 1, Day 3, Day 5, Month 3
Percentage of mRS≤2 on Month 3
Time frame: Month 3
Incidence of major cardiovascular events on Month 3
Time frame: Month 3
Incidence of adverse events on Month 3
Time frame: Month 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 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.
Meng Ran, PhD study chair
Xuanwu Hospital, Beijing
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke, run by Xuanwu Hospital, Beijing.
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 7 inclusion and 10 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 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Meng Ran, PhD (+86-10-83199280, victor65@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LDL-C target achievement rate on Day 5, Month 3 (time frame: Day 5, Month 3). 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 18 Nov 2023.