Acute StrokePhase 2EPOCH-LYSISNCT07301372
Evaluation Study of Early Administration of Evolocumab After Thrombolysis in Patients With Atherosclerotic Acute Ischemic Stroke
A Phase 2 study testing Ivolumab 420mg (three vials) in people with Acute Stroke, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
Trial summary
This study is a Phase IIa clinical trial initiated by the researchers, which is prospective, single-center, randomized, open-label, with blinded endpoint evaluation (PROBE design). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Stroke
- What is being tested?
- Ivolumab 420mg (three vials)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2025to 1 Jun 2026
- Phase
- Phase 2
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age 18-85 years. No gender or sex restrictions, and no gender ratio restrictions.
- 2. Clinically diagnosed with acute ischemic stroke, with the time from symptom onset to intravenous thrombolysis <9 hours.
- Within 4.5 hours of symptom onset: This time window is based on the ECASS III criteria (Class IA recommendation) and is currently the standard indication for intravenous thrombolysis in acute ischemic stroke worldwide.
- 4.5-9 hours: Referring to the EXTEND study criteria, meeting the following multimodal imaging mismatch ratio: ischemic penumbra volume/ischemic core volume >1.2, with an absolute mismatch volume >10 mL and an ischemic core volume <70 mL.
- 3. The stroke meets the TOAST classification for large artery atherosclerosis (LAA), which includes intracranial arteriosclerosis (ICAS) and extracranial arteriosclerosis (ECAS), and meets one of the following three criteria: large artery stenosis ≥50%, infarct lesion >1.5cm + ipsilateral plaque (no stenosis requirement), or intracranial artery stenosis ≥30% with plaque ulceration.
- 4. The patient or their legal representative has signed an informed consent form.
Who cannot join
- 1. CT scan showing signs of intracranial hemorrhage, symptomatic intracranial hemorrhage, or subarachnoid hemorrhage, even if the CT scan results are normal.
- 2. Patients who must or wish to continue using restrictive medications or any medications that may interfere with the safe conduct of the trial.
- 3. Acute bleeding tendency, including but not limited to:
- A known family history of bleeding disorders and a history of a serious bleeding disorder currently present or within the past 6 months.
- Receiving heparin treatment within the past 48 hours, with an activated partial thromboplastin time (aPTT) exceeding the upper limit of the normal range for laboratory testing.
- Currently taking an oral vitamin K anticoagulant (e.g., warfarin) with a prolonged prothrombin time (INR > 1.7 or PT > 15 seconds); or currently taking a novel oral anticoagulant (e.g., dabigatran etexilate, rivaroxaban, or apixaban) with an activated partial thromboplastin time (aPTT) and/or prothrombin time (PT) exceeding the upper limit of the local laboratory reference range.
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- Platelet count below 100,000/mm³ at screening.
- History of central nervous system injury (e.g., tumor, aneurysm, intracranial or spinal surgery).
- Experiencing traumatic external cardiac compression, obstetric delivery, or non-compressive vascular puncture (e.g., subclavian or jugular vein puncture) within the past 10 days.
- Known history of suspected intracranial hemorrhage or suspected aneurysm/subarachnoid hemorrhage.
- Tumors with increased bleeding risk.
- History of ulcerative gastrointestinal disease, esophageal varices, aneurysm, or arteriovenous malformation within the past 3 months.
- Associated with bleeding risk. 4. Any known disease significantly associated with this condition.
- 4. Previous mRS score ≥2, with comorbid dementia or other neurodegenerative diseases.
- 5. Clinically confirmed non-atherosclerotic intracranial arterial stenosis, such as aortic dissection, vasculitis, moyamoya disease, embolism, immune system disorders, etc.
- 6. Other comorbid medical histories that may affect endpoint event determination and follow-up, such as history of traumatic brain injury, multiple sclerosis, encephalitis, tumors, poisoning, syphilis, and severe heart, lung, liver, kidney, or endocrine diseases.
- 7. Pregnant women.
- 8. Currently participating in other experimental device or drug studies, or having completed other experimental device or drug studies, or having received other experimental treatments for less than 30 days.
- 9. Having used PCSK9 inhibitors within 4 weeks prior to enrollment.
- 10. Hypersensitivity to statins or PCSK9 inhibitors.
- 11. Patients with severe hepatic or renal impairment (eGFR <30 ml/min/1.73 m²).
- 12. Refusal to sign informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Blinded Endpoint Evaluation Study of Early Administration of Evolocumab After Thrombolysis in Patients With Atherosclerotic Acute Ischemic Stroke
This study is a Phase IIa clinical trial initiated by the researchers, which is prospective, single-center, randomized, open-label, with blinded endpoint evaluation (PROBE design). Patients were screened through the emergency stroke green channel and included if they had an onset within 9 hours, met the criteria for large artery atherosclerosis (LAA) after multimodal imaging screening, received intravenous thrombolysis, and signed informed consent to participate. The study used block randomization (block size of 4), stratified by baseline National Institutes of Health Stroke Scale (NIHSS) score (5-10 vs >10-20) and onset-to-thrombolysis time (<4.5 hours vs 4.5-9 hours).
Intervention group: received subcutaneous injections of Ilyumumab 420 mg (three syringes) within 24 hours after thrombolysis plus standard drug therapy (including statins). Control group: received conventional statin therapy (atorvastatin 20 mg/day) after thrombolysis. All patients received standardized stroke treatment (initiating antiplatelet therapy 24 hours after thrombolysis) and standardized management of blood pressure and blood glucose.
Read more
NIHSS scores were assessed every 12 hours within 72 hours post-thrombolysis, and then daily thereafter, to evaluate the effectiveness of combined therapy in reducing early neurological deterioration (END).
Blinding: The study is open-label. An independent Clinical Endpoint Committee (CEC) was established, and all clinical endpoint events (END assessment, 90-day mRS scores) were evaluated in a blinded manner by experts who were completely unaware of group assignments.
- Conditions
- Acute Stroke
- Being tested
- Ivolumab 420mg (three vials)
- Keywords
- PCSK9 inhibitor, Inflammatory factor, Biomarkers of brain injury, Atorvastatin, Early neurological deterioration
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivolumab 420mg (three vials)Drug
Administer 420 mg (three vials) of evolocumab subcutaneously within 24 hours after thrombolysis.
| Study group | Role | What they receive |
|---|---|---|
| evolocumab | Experimental | Within 24 hours after thrombolysis, patients received subcutaneous injections of 420 mg evokine and three vials of evokine, along with standard statin therapy (atorvastatin 20 mg/day). Receives: Drug: Ivolumab 420mg (three vials) |
| Standard of care | No intervention | Following thrombolysis, the patient received standard statin therapy (atorvastatin 20 mg/day). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early deterioration of neurological function (END)
Defined as an increase of ≥2 points in NIHSS score or death within 1-7 days after thrombolysis. NIHSS scores should be assessed daily.The NIHSS (National Institutes of Health Stroke Scale) has a total score of 0 to 42. The higher the total score, the more severe the neurological deficit caused by stroke.
Measured: within 1-7 days after thrombolysis.
Secondary outcomes (9)
Therapeutic efficacy
90-day functional prognosis (mRS 0-2 score rate and ordered shift analysis).The Modified Rankin Scale (MRS) is a core tool for assessing the degree of neurological function recovery in patients with stroke or other neurological disorders. The score ranges from 0 to 6, with higher scores indicating a more severe degree of disability.
Measured: Within 90 days after thrombolysis
Mechanism exploration
Dynamic changes in serum PCSK9 levels from baseline to 36 hours and 72 hours after thrombolysis,and the correlation between these changes and the end of the treatment period.
Measured: from baseline to 36 hours and 72 hours after thrombolysis.
Mechanism Exploration
Dynamic changes in serum hsCRP levels from baseline to 36 hours and 72 hours after thrombolysis,and the correlation between these changes and the end of the treatment period.
Measured: from baseline to 36 hours and 72 hours after thrombolysis
Mechanism Exploration
Dynamic changes in serum IL-6 levels from baseline to 36 hours and 72 hours after thrombolysis,and the correlation between these changes and the end of the treatment period.
Measured: from baseline to 36 hours and 72 hours after thrombolysis
Mechanism Exploration
Dynamic changes in serum NSE and S100β levels from baseline to 36 hours and 72 hours after thrombolysis, and the correlation between these changes and the end of the treatment period.
Measured: from baseline to 36 hours and 72 hours after thrombolysis
Preset subgroup analysis
The impact of onset to thrombolysis time (<4.5h vs 4.5-9h) on the primary efficacy endpoint.The efficacy therapeutic endpoint was early deterioration of neurological function (END).Defined as an increase of ≥2 points in NIHSS score or death within 1-7 days after thrombolysis. NIHSS scores should be assessed daily.The NIHSS (National Institutes of Health Stroke Scale) has a total score of 0 to 42. The higher the total score, the more severe the neurological deficit caused by stroke.
Measured: within 1-7 days after thrombolysis
Plasma Lysophosphatidylcholine (LPC) Lipidomic Profile
Temporal changes in the relative abundance of lysophosphatidylcholine (LPC) species will be assessed to compare lipidomic trajectories between the evolocumab and control groups.
Measured: Baseline, 36 ± 6 hours, and 72 ± 12 hours after intravenous thrombolysis
Plasma Ceramide Lipidomic Profile
Temporal changes in the relative abundance of ceramide species will be assessed to compare lipidomic trajectories between the evolocumab and control groups.
Measured: Baseline, 36 ± 6 hours, and 72 ± 12 hours after intravenous thrombolysis
Plasma Phosphatidylethanolamine Plasmalogen (PE-Plasmalogen) Lipidomic Profile
Temporal changes in the relative abundance of phosphatidylethanolamine plasmalogen (PE-plasmalogen) species will be assessed to compare lipidomic trajectories between the evolocumab and control groups.
Measured: Baseline, 36 ± 6 hours, and 72 ± 12 hours after intravenous thrombolysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start30 Oct 2025
- Primary completion8 Mar 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute StrokeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ren Guo Chen, Study director, the Ethics Committee of the Affiliated Hospital of Xuzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07301372
- Sponsor's protocol ID
- XYFY2025-KL477-01
- Acronym
- EPOCH-LYSIS
- Status last verified
- Aug 2026
- First submitted
- 27 Nov 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants do not consent to the data sharing about themselves. IPD involves privacy and ethical issues.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Blinded Endpoint Evaluation Study of Early Administration of Evolocumab After Thrombolysis in Patients With Atherosclerotic Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT07301372
- Acronym / sponsor ID
- EPOCH-LYSIS / XYFY2025-KL477-01
- Conditions
- Acute Stroke
- Keywords
- PCSK9 inhibitor, Inflammatory factor, Biomarkers of brain injury, Atorvastatin, Early neurological deterioration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- 8 Mar 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 24 Dec 2025 (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 study is a Phase IIa clinical trial initiated by the researchers, which is prospective, single-center, randomized, open-label, with blinded endpoint evaluation (PROBE design). Patients were screened through the emergency stroke green channel and included if they had an onset within 9 hours, met the criteria for large artery atherosclerosis (LAA) after multimodal imaging screening, received intravenous thrombolysis, and signed informed consent to participate. The study used block randomization (block size of 4), stratified by baseline National Institutes of Health Stroke Scale (NIHSS) score (5-10 vs >10-20) and onset-to-thrombolysis time (<4.5 hours vs 4.5-9 hours).
Intervention group: received subcutaneous injections of Ilyumumab 420 mg (three syringes) within 24 hours after thrombolysis plus standard drug therapy (including statins). Control group: received conventional statin therapy (atorvastatin 20 mg/day) after thrombolysis. All patients received standardized stroke treatment (initiating antiplatelet therapy 24 hours after thrombolysis) and standardized management of blood pressure and blood glucose.
NIHSS scores were assessed every 12 hours within 72 hours post-thrombolysis, and then daily thereafter, to evaluate the effectiveness of combined therapy in reducing early neurological deterioration (END).
Blinding: The study is open-label. An independent Clinical Endpoint Committee (CEC) was established, and all clinical endpoint events (END assessment, 90-day mRS scores) were evaluated in a blinded manner by experts who were completely unaware of group assignments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| evolocumab | Experimental | Drug: Ivolumab 420mg (three vials)Within 24 hours after thrombolysis, patients received subcutaneous injections of 420 mg evokine and three vials of evokine, along with standard statin therapy (atorvastatin 20 mg/day). |
| Standard of care | No intervention | –Following thrombolysis, the patient received standard statin therapy (atorvastatin 20 mg/day). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Age 18-85 years. No gender or sex restrictions, and no gender ratio restrictions.
- 2. Clinically diagnosed with acute ischemic stroke, with the time from symptom onset to intravenous thrombolysis <9 hours.
- Within 4.5 hours of symptom onset: This time window is based on the ECASS III criteria (Class IA recommendation) and is currently the standard indication for intravenous thrombolysis in acute ischemic stroke worldwide.
- 4.5-9 hours: Referring to the EXTEND study criteria, meeting the following multimodal imaging mismatch ratio: ischemic penumbra volume/ischemic core volume >1.2, with an absolute mismatch volume >10 mL and an ischemic core volume <70 mL.
- 3. The stroke meets the TOAST classification for large artery atherosclerosis (LAA), which includes intracranial arteriosclerosis (ICAS) and extracranial arteriosclerosis (ECAS), and meets one of the following three criteria: large artery stenosis ≥50%, infarct lesion >1.5cm + ipsilateral plaque (no stenosis requirement), or intracranial artery stenosis ≥30% with plaque ulceration.
Key exclusion criteria (22 listed)
- 1. CT scan showing signs of intracranial hemorrhage, symptomatic intracranial hemorrhage, or subarachnoid hemorrhage, even if the CT scan results are normal.
- 2. Patients who must or wish to continue using restrictive medications or any medications that may interfere with the safe conduct of the trial.
- A known family history of bleeding disorders and a history of a serious bleeding disorder currently present or within the past 6 months.
- Receiving heparin treatment within the past 48 hours, with an activated partial thromboplastin time (aPTT) exceeding the upper limit of the normal range for laboratory testing.
- Currently taking an oral vitamin K anticoagulant (e.g., warfarin) with a prolonged prothrombin time (INR > 1.7 or PT > 15 seconds); or currently taking a novel oral anticoagulant (e.g., dabigatran etexilate, rivaroxaban, or apixaban) with an activated partial thromboplastin time (aPTT) and/or prothrombin time (PT) exceeding the upper limit of the local laboratory reference range.
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 |
|---|---|---|
| Ivolumab 420mg (three vials)Administer 420 mg (three vials) of evolocumab subcutaneously within 24 hours after thrombolysis. | Drug | evolocumab |
Primary outcome
Early deterioration of neurological function (END)
Time frame: within 1-7 days after thrombolysis.
Defined as an increase of ≥2 points in NIHSS score or death within 1-7 days after thrombolysis. NIHSS scores should be assessed daily.The NIHSS (National Institutes of Health Stroke Scale) has a total score of 0 to 42. The higher the total score, the more severe the neurological deficit caused by stroke.
9 secondary outcomes
Therapeutic efficacy
Time frame: Within 90 days after thrombolysis
Mechanism exploration
Time frame: from baseline to 36 hours and 72 hours after thrombolysis.
Mechanism Exploration
Time frame: from baseline to 36 hours and 72 hours after thrombolysis
Mechanism Exploration
Time frame: from baseline to 36 hours and 72 hours after thrombolysis
Mechanism Exploration
Time frame: from baseline to 36 hours and 72 hours after thrombolysis
Preset subgroup analysis
Time frame: within 1-7 days after thrombolysis
Plasma Lysophosphatidylcholine (LPC) Lipidomic Profile
Time frame: Baseline, 36 ± 6 hours, and 72 ± 12 hours after intravenous thrombolysis
Plasma Ceramide Lipidomic Profile
Time frame: Baseline, 36 ± 6 hours, and 72 ± 12 hours after intravenous thrombolysis
Plasma Phosphatidylethanolamine Plasmalogen (PE-Plasmalogen) Lipidomic Profile
Time frame: Baseline, 36 ± 6 hours, and 72 ± 12 hours after intravenous thrombolysis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No. Participants do not consent to the data sharing about themselves. IPD involves privacy and ethical issues.
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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.
Ren Guo Chen study director
the Ethics Committee of the Affiliated Hospital of Xuzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ivolumab 420mg (three vials) in people with Acute Stroke, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
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 22 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 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Early deterioration of neurological function (END) (time frame: within 1-7 days after thrombolysis.). 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 10 Sep 2026.