Acute StrokePhase 4EPOCH-TECTNCT07295366
Early Administration of PCSK9 Inhibitors After Thrombectomy for Atherosclerotic Acute Ischemic Stroke: A Randomized Controlled Trial
A Phase 4 study testing Evolocumab(420 mg injections) in people with Acute Stroke, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
Trial summary
This study (EPOCH-TECT) was a single-center, randomized, open-label, blinded, endpoint-assessing controlled trial conducted at the Affiliated Hospital of Xuzhou Medical University. 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?
- Evolocumab(420 mg injections)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2025to 1 May 2026
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-85 years old, gender not limited, gender ratio not limited.
- The clinical diagnosis was acute ischemic stroke with occlusion of the anterior circulation large vessels. CTA/DSA confirmed that the responsible vessel for this stroke occlusion was located in the intracranial segment of the internal carotid artery and the M1 segment of the middle cerebral artery.
- The time from onset to puncture is within 24 hours, and the patient receives mechanical thrombectomy (MT) (including direct thrombectomy and intravenous thrombolysis bridging thrombectomy), with postoperative vascular recanalization reaching mTICI grade 2b or 3. The surgical indications and time window follow the current guidelines and imaging criteria of key randomized controlled trials (RCTs). The definitions are as follows: Early window (0-6 h): Meeting the usual EVT indications (anterior circulation LVO, baseline NIHSS ≥ 6, ASPECTS ≥ 6, or center-defined criteria), the interventional team decides to perform MT; Late window (6-24 h): Meeting one of the imaging selection criteria of DAWN or DEFUSE-3 (based on CTP-RAPID or MRI-DWI/perfusion):
- ·DAWN (6-24 h) (any one): Age ≥ 80 years: NIHSS ≥ 10 and core infarct volume < 21 mL; Age < 80 years: NIHSS ≥ 10 and core < 31 mL; Age < 80 years: NIHSS ≥ 20 and core 31-51 mL.
- DEFUSE-3 (6-16 h) (all conditions must be met): Core <70 mL, mismatch ratio (penumbra/core) ≥1.8, mismatch volume ≥15 mL, and Tmax >6 s volume >15 mL.
- The etiological classification is intracranial arteriosclerosis-LAA (ICAD-LAA). The definition is as follows: imaging evidence supports the presence of atherosclerotic stenosis/plaque in the responsible vessel (such as severe stenosis/occlusion of the proximal internal carotid artery or middle cerebral artery) and the patient has corresponding underlying atherosclerosis (such as other intracranial/extracranial artery stenosis, hypertension, diabetes, etc.).
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- Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥ 6 points.
- Before the onset of the disease, the patient had good daily living abilities and an mRS score ≤ 2 (no severe disability).
- Able to complete the injection of research drugs as required.
- The patient or his or her legal representative shall sign a written informed consent form, understand the research content and agree to cooperate with the follow-up.
Who cannot join
- Non-atherosclerotic lesions (such as arterial dissection, Moyamoya disease, vasculitis, embolism of unknown origin, etc.).
- Patients who present with significant intracranial hemorrhage or excessively large cerebral infarction volume upon admission, making them unsuitable for continued participation in the study.
- The cause of stroke is cardioembolism (such as a history of heart disease such as atrial fibrillation or valvular heart disease).
- Individuals with a clear history of allergy to evolocumab or its excipients.
- Patients with severe liver and kidney dysfunction: baseline alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal, or significantly reduced creatinine clearance (eGFR < 30 mL/min/1.73m²).
- Patients with active severe infection, immune system disease or other serious comorbidities that may significantly affect prognosis (such as active tumors, terminal diseases, etc.).
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- Patients who have been treated with PCSK9 inhibitors within the past 4 weeks (to avoid affecting the study due to changes in tolerance or mechanism of action).
- Pregnant or lactating women.
- Expected survival <90 days or accompanied by other serious diseases.
- Currently participating in other interventional clinical studies.
Trial locations and contacts
1 site in 1 country.
About this study
This study (EPOCH-TECT) was a single-center, randomized, open-label, blinded, endpoint-assessing controlled trial conducted at the Affiliated Hospital of Xuzhou Medical University. It aimed to investigate the efficacy and safety of administering the PCSK9 inhibitor evolocumab early (within 6 hours) after successful thrombectomy in patients with atherosclerotic large vessel occlusive stroke. The study planned to enroll 60 patients, who were randomly assigned 1:1 to either the "thrombectomy + evolocumab" group or the "thrombectomy alone" group. The primary endpoint was the incidence of early neurological deterioration within 7 days post-procedure (NIHSS score increase ≥2 points from post-operative best or death from any cause); secondary endpoints included 24-hour recanalization failure rate, 90-day functional recovery (mRS score 0-2), changes in serum biomarkers, and safety indicators such as symptomatic intracranial hemorrhage. This study aimed to provide prospective evidence for early intensive lipid-lowering and neuroprotective strategies after thrombectomy.
- Conditions
- Acute Stroke
- Being tested
- Evolocumab(420 mg injections)
- Keywords
- Acute Ischemic Stroke, Mechanical Thrombectomy, Atherosclerosis, PCSK9 Inhibitor, Early Neurological Deterioration
- Medical subject headings
- Stroke, Ischemic Stroke, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evolocumab(420 mg injections)Drug
Intervention Group: Thrombectomy alone + evolocumab Thrombectomy alone: Mechanical thrombectomy performed according to guidelines (may include necessary angioplasty/stent implantation). Elavolocumab: 420 mg subcutaneously injected within 6 hours after recanalization (140 mg x 3 injections, pre-filled 3 mL total), at the location of the abdomen, lateral thigh, or lateral upper arm.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Intervention Group: Thrombectomy alone + evolocumab
Thrombectomy alone: Mechanical thrombectomy performed according to guidelines (may include necessary angioplasty/stent implantation).
Evolocumab: 420 mg subcutaneously injected within 6 hours after recanalization (140 mg x 3 injections, pre-filled 3 mL total), at the location of the abdomen, lateral thigh, or lateral upper arm.
Both groups received standardized drug therapy: antithrombotic/lipid-regulating/blood pressure/blood glucose/fluid management and rehabilitation: in accordance with the latest clinical guidelines. Receives: Drug: Evolocumab(420 mg injections) |
| control group | No intervention | Control group: simple thrombectomy Both groups received standardized drug therapy: antithrombotic/lipid-regulating/blood pressure/blood glucose/fluid management and rehabilitation: in accordance with the latest clinical guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early deterioration of neurological function (END)
The incidence of early neurological deterioration (END) within 7 days, defined as an increase of ≥2 points in NIHSS score compared to the best post-procedure level or death from any cause.
Measured: Within 7 days post-thrombectomy
Incidence of symptomatic intracranial hemorrhage (sICH) within 90 days, defined according to the Heidelberg Bleeding Classification criteria.
Incidence of symptomatic intracranial hemorrhage (sICH) within 90 days, defined according to the Heidelberg Bleeding Classification criteria.
Measured: Within 90 days post-thrombectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start20 Dec 2025
- Primary completion1 May 2026
- Study completion1 May 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu Feng, MD, PhD, Principal investigator, The Affiliated Hospital of Xuzhou Medical UniversityYanbo Cheng, MD, PhD, Study director, The Affiliated Hospital of Xuzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07295366
- Sponsor's protocol ID
- XYFY2025-KL574-01
- Acronym
- EPOCH-TECT
- Status last verified
- May 2026
- First submitted
- 7 Dec 2025
- Last updated
- 13 Jul 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 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Administration of PCSK9 Inhibitors After Thrombectomy for Atherosclerotic Acute Ischemic Stroke: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07295366
- Acronym / sponsor ID
- EPOCH-TECT / XYFY2025-KL574-01
- Conditions
- Acute Stroke
- Keywords
- Acute Ischemic Stroke, Mechanical Thrombectomy, Atherosclerosis, PCSK9 Inhibitor, Early Neurological Deterioration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 20 Dec 2025 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 19 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 (EPOCH-TECT) was a single-center, randomized, open-label, blinded, endpoint-assessing controlled trial conducted at the Affiliated Hospital of Xuzhou Medical University. It aimed to investigate the efficacy and safety of administering the PCSK9 inhibitor evolocumab early (within 6 hours) after successful thrombectomy in patients with atherosclerotic large vessel occlusive stroke. The study planned to enroll 60 patients, who were randomly assigned 1:1 to either the "thrombectomy + evolocumab" group or the "thrombectomy alone" group. The primary endpoint was the incidence of early neurological deterioration within 7 days post-procedure (NIHSS score increase ≥2 points from post-operative best or death from any cause); secondary endpoints included 24-hour recanalization failure rate, 90-day functional recovery (mRS score 0-2), changes in serum biomarkers, and safety indicators such as symptomatic intracranial hemorrhage. This study aimed to provide prospective evidence for early intensive lipid-lowering and neuroprotective strategies after thrombectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Drug: Evolocumab(420 mg injections)Intervention Group: Thrombectomy alone + evolocumab Thrombectomy alone: Mechanical thrombectomy performed according to guidelines (may include necessary angioplasty/stent implantation). Evolocumab: 420 mg subcutaneously injected within 6 hours after recanalization (140 mg x 3 injections, pre-filled 3 mL total), at the location of the abdomen, lateral thigh, or lateral upper arm. Both groups received standardized drug therapy: antithrombotic/lipid-regulating/blood pressure/blood glucose/fluid management and rehabilitation: in accordance with the latest clinical guidelines. |
| control group | No intervention | –Control group: simple thrombectomy Both groups received standardized drug therapy: antithrombotic/lipid-regulating/blood pressure/blood glucose/fluid management and rehabilitation: in accordance with the latest clinical guidelines. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18-85 years old, gender not limited, gender ratio not limited.
- The clinical diagnosis was acute ischemic stroke with occlusion of the anterior circulation large vessels. CTA/DSA confirmed that the responsible vessel for this stroke occlusion was located in the intracranial segment of the internal carotid artery and the M1 segment of the middle cerebral artery.
- The time from onset to puncture is within 24 hours, and the patient receives mechanical thrombectomy (MT) (including direct thrombectomy and intravenous thrombolysis bridging thrombectomy), with postoperative vascular recanalization reaching mTICI grade 2b or 3. The surgical indications and time window follow the current guidelines and imaging criteria of key randomized controlled trials (RCTs). The definitions are as follows: Early window (0-6 h): Meeting the usual EVT indications (anterior circulation LVO, baseline NIHSS ≥ 6, ASPECTS ≥ 6, or center-defined criteria), the interventional team decides to perform MT; Late window (6-24 h): Meeting one of the imaging selection criteria of DAWN or DEFUSE-3 (based on CTP-RAPID or MRI-DWI/perfusion):
- ·DAWN (6-24 h) (any one): Age ≥ 80 years: NIHSS ≥ 10 and core infarct volume < 21 mL; Age < 80 years: NIHSS ≥ 10 and core < 31 mL; Age < 80 years: NIHSS ≥ 20 and core 31-51 mL.
- The etiological classification is intracranial arteriosclerosis-LAA (ICAD-LAA). The definition is as follows: imaging evidence supports the presence of atherosclerotic stenosis/plaque in the responsible vessel (such as severe stenosis/occlusion of the proximal internal carotid artery or middle cerebral artery) and the patient has corresponding underlying atherosclerosis (such as other intracranial/extracranial artery stenosis, hypertension, diabetes, etc.).
Key exclusion criteria (10 listed)
- Non-atherosclerotic lesions (such as arterial dissection, Moyamoya disease, vasculitis, embolism of unknown origin, etc.).
- Patients who present with significant intracranial hemorrhage or excessively large cerebral infarction volume upon admission, making them unsuitable for continued participation in the study.
- The cause of stroke is cardioembolism (such as a history of heart disease such as atrial fibrillation or valvular heart disease).
- Individuals with a clear history of allergy to evolocumab or its excipients.
- Patients with severe liver and kidney dysfunction: baseline alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal, or significantly reduced creatinine clearance (eGFR < 30 mL/min/1.73m²).
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 |
|---|---|---|
| Evolocumab(420 mg injections)Intervention Group: Thrombectomy alone + evolocumab Thrombectomy alone: Mechanical thrombectomy performed according to guidelines (may include necessary angioplasty/stent implantation). Elavolocumab: 420 mg subcutaneously injected within 6 hours after recanalization (140 mg x 3 injections, pre-filled 3 mL total), at the location of the abdomen, lateral thigh, or lateral upper arm. | Drug | intervention group |
Primary outcome
Early deterioration of neurological function (END)
Time frame: Within 7 days post-thrombectomy
The incidence of early neurological deterioration (END) within 7 days, defined as an increase of ≥2 points in NIHSS score compared to the best post-procedure level or death from any cause.
Incidence of symptomatic intracranial hemorrhage (sICH) within 90 days, defined according to the Heidelberg Bleeding Classification criteria.
Time frame: Within 90 days post-thrombectomy
Incidence of symptomatic intracranial hemorrhage (sICH) within 90 days, defined according to the Heidelberg Bleeding Classification criteria.
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 13 Jul 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.
Yu Feng, MD, PhD principal investigator
The Affiliated Hospital of Xuzhou Medical University
Yanbo Cheng, MD, PhD study director
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 4 study testing Evolocumab(420 mg injections) 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 10 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: finished, as of the sponsor's last update on 13 Jul 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 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?
Early deterioration of neurological function (END) (time frame: Within 7 days post-thrombectomy). The study lists 2 primary outcomes in all. 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 13 Jul 2026.