Ischemic Stroke, AcutePhase 4SEEISNCT05697185
Safety and Efficacy of Evolocumab in Ischemic Stroke
A Phase 4 study testing Evolocumab in people with Ischemic Stroke, Acute, run by Second Affiliated Hospital of Guangxi Medical University.
Trial summary
The goal of this clinical trial is to evaluate the effect of evolocumab in combination with statin therapy (atorvastatin) in acute ischemic stroke (AIS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Acute
- What is being tested?
- Evolocumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2023to 1 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient age between 18-80 years
- Time of onset: within 1 week
- NIHSS score ≤12
- Acute ischemic stroke confirmed by head CT or MRI
- Premorbid mRS ≤1
- Signed informed consent
Who cannot join
- Intracranial hemorrhage found by head CT
- Severe hepatic or renal dysfunction
- Pregnant females
- Abnormal elevation of creatine phosphokinase
- Blood sugar is out of control
- Receiving statins within 1 month before onset
- Not willing and able to comply with scheduled visits, lifestyle guidelines, treatment plan, laboratory tests, and other study procedures
- Unsuitable for this clinical studies assessed by researcher
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Safety and Efficacy of Evolocumab in in Combination With Statin Therapy in Adults With Ischemic Stroke
The goal of this clinical trial is to evaluate the effect of evolocumab in combination with statin therapy (atorvastatin) in acute ischemic stroke (AIS).
- Conditions
- Ischemic Stroke, Acute
- Being tested
- Evolocumab
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvolocumabDrug
Patients were randomly assigned of the ratio of 1:1 using a computer-generated random number and divided into two treatment groups: the statin alone therapy and the evolocumab plus statin therapy.
| Study group | Role | What they receive |
|---|---|---|
| the evolocumab plus statin therapy | Experimental | Patients with AIS are treated with atorvastatin (40mg) daily and evolocumab (420 mg) every months throughout the study period Receives: Drug: Evolocumab |
| the statin alone therapy | No intervention | Patients with AIS are treated with atorvastatin (40mg) daily throughout the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in LDL-C
Measured: baseline, 4 weeks, 8 weeks, 12 weeks after treatment
Secondary outcomes (3)
Vascular events
incidence of Transient ischemic attack, stroke or other vascular events
Measured: 3 months, 6months
mRS (0-2)
proportion of mRS (0-2)
Measured: 3 months, 6months
death of any causes
proportion of death
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start1 Feb 2023 (estimated)
- Primary completion1 Feb 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic Stroke, AcuteStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Guangxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junli Liang, Second Affiliated Hospital of Guangxi Medical University
- Investigators
- Junli Liang, PhD, Study director, The Second Affiliated Hospital of Guangxi Medical University, Nanning, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05697185
- Sponsor's protocol ID
- KY-0012
- Acronym
- SEEIS
- Status last verified
- Jan 2023
- First submitted
- 15 Jan 2023
- Last updated
- 25 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Qiu X, Liang Y, Wei Y, Lu M, Mei Y, Tang S, Tang J, Liang J, Liang J. Evolocumab for early reduction of LDL-C levels in patients with acute ischemic stroke: a randomized controlled trial. Front Neurol. 2024 Dec 23;15:1454608. doi: 10.3389/fneur.2024.1454608. eCollection 2024.
PubMed 39764289
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Evolocumab in in Combination With Statin Therapy in Adults With Ischemic Stroke
- ClinicalTrials.gov ID
- NCT05697185
- Acronym / sponsor ID
- SEEIS / KY-0012
- Conditions
- Ischemic Stroke, Acute
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Guangxi Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 25 Jan 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.
The goal of this clinical trial is to evaluate the effect of evolocumab in combination with statin therapy (atorvastatin) in acute ischemic stroke (AIS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the evolocumab plus statin therapy | Experimental | Drug: EvolocumabPatients with AIS are treated with atorvastatin (40mg) daily and evolocumab (420 mg) every months throughout the study period |
| the statin alone therapy | No intervention | –Patients with AIS are treated with atorvastatin (40mg) daily throughout the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient age between 18-80 years
- Time of onset: within 1 week
- NIHSS score ≤12
- Acute ischemic stroke confirmed by head CT or MRI
- Premorbid mRS ≤1
Key exclusion criteria (8 listed)
- Intracranial hemorrhage found by head CT
- Severe hepatic or renal dysfunction
- Pregnant females
- Abnormal elevation of creatine phosphokinase
- Blood sugar is out of control
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 |
|---|---|---|
| EvolocumabPatients were randomly assigned of the ratio of 1:1 using a computer-generated random number and divided into two treatment groups: the statin alone therapy and the evolocumab plus statin therapy. | Drug | the evolocumab plus statin therapy |
Primary outcome
Percent change in LDL-C
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks after treatment
3 secondary outcomes
Vascular events
Time frame: 3 months, 6months
mRS (0-2)
Time frame: 3 months, 6months
death of any causes
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Derived from this study: PubMed 39764289Qiu X, Liang Y, Wei Y, Lu M, Mei Y, Tang S, Tang J, Liang J, Liang J. Evolocumab for early reduction of LDL-C levels in patients with acute ischemic stroke: a randomized controlled trial. Front Neurol. 2024 Dec 23;15:1454608. doi: 10.3389/fneur.2024.1454608. eCollection 2024.
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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.
Junli Liang, PhD study director
The Second Affiliated Hospital of Guangxi Medical University, Nanning, China
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Evolocumab in people with Ischemic Stroke, Acute, run by Second Affiliated Hospital of Guangxi Medical University.
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 6 inclusion and 8 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 25 Jan 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.
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 Junli Liang, PhD (+86-13481138068, liangjl80@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in LDL-C (time frame: baseline, 4 weeks, 8 weeks, 12 weeks after treatment). 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 NCT05697185, 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 25 Jan 2023.