Acute Ischemic StrokePhase 2/3PCSK9-PROVENCT07174375
PCSK9 Inhibitors in Acute Ischemic Stroke Patients Undergoing Endovascular Therapy
A Phase 2/3 study testing PCSK9 inhibitor in people with Acute Ischemic Stroke, run by Nanfang Hospital, Southern Medical University at 12 sites in China.
Trial summary
This is a prospective, multicenter, randomized controlled clinical study to evaluate the efficacy of PCSK9 inhibitor in addition to standard therapy in patients with acute ischemic stroke undergoing endovascular therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- PCSK9 inhibitor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 478 participants
- Where
- 12 sitesChina
- Study dates
- 15 Sep 2025to 15 Dec 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years.
- Meets the diagnostic criteria for acute ischemic stroke according to the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023.
- Severe stenosis or occlusion of large anterior circulation vessels confirmed by DSA, MRA, or CTA.
- Preoperative NIHSS score ≥ 4 and < 25.
- Meets the indications for endovascular therapy per the Chinese Guidelines for Endovascular Therapy of Acute Ischemic Stroke 2023, and successful reperfusion of the target vessel (mTICI ≥ 2b) achieved via emergency endovascular intervention.
- LDL-C > 1.8 mmol/L or non-HDL cholesterol > 2.6 mmol/L.
- Signed informed consent provided by the patient or their legally authorized representative.
Who cannot join
- Confirmed non-atherosclerotic causes of vascular stenosis/occlusion (e.g., cardioembolism, vasculitis, vascular malformation, moyamoya disease, iatrogenic causes).
- History of intracranial hemorrhage or systemic bleeding within the past 3 months.
- Presence of hemorrhagic transformation (PH1/PH2) immediately after the procedure.
- Severe hepatic impairment: ALT > 3 times the upper limit of normal, INR > 1.2, hepatic encephalopathy, or history of drug-induced liver injury.
- Use of PCSK9 inhibitors within 6 months prior to enrollment.
- Pre-stroke mRS ≥ 2.
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- Terminal illness (e.g., malignancy, end-stage renal disease) with an expected survival of < 3 months.
- Pregnancy or lactation.
- Other neurological diseases that may interfere with neurological function assessment during follow-up.
- Allergy or intolerance to PCSK9 inhibitors or statins.
- Participation in another interventional clinical trial.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
China12 sites
Dongguan Donghua Hospital
Dongguan, Guangdong
Dongguan People's Hospital
Dongguan, Guangdong
Fujian Medical University Union Hospital
Fuzhou, Fujian
Ganzhou City People's Hospital
Ganzhou, Jiangxi
Huadu District People's Hospital of Guangzhou
Guangzhou, Guangdong
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong
Hainan Provincial Hospital of Traditional Chinese Medicine
Haikou, Hainan, 570100
Haikou People's Hospital
Haikou, Hainan
Hainan Provincial People's Hospital
Haikou, Hainan
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan
Pengxiang Li, M.D., 13907615510
Hengzhou City People's Hospital, Guangxi
Hengzhou, Guangxi (Autonomous Region)
Youai Chen, M.D., +8613192657996
Heyuan People's Hospital
Heyuan, Guangdong
About this study
Official title: Efficacy and Safety of PCSK9 Inhibitors in Patients With Acute Ischemic Stroke Undergoing Endovascular Therapy: A Prospective, Multicenter, Open-Label, Parallel, Randomized Controlled Clinical Trial
This is a prospective, multicenter, randomized controlled clinical study to evaluate the efficacy of PCSK9 inhibitor in addition to standard therapy in patients with acute ischemic stroke undergoing endovascular therapy.
- Conditions
- Acute Ischemic Stroke
- Being tested
- PCSK9 inhibitor
- Keywords
- acute ischemic stroke, endovascular therapy, PCSK9 inhibitors, Lipid-Lowering Therapy, Early Artery Reocclusion
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCSK9 inhibitorDrug
Also called Evolocumab, Alirocumab
PCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) inhibitors are a class of monoclonal antibody drugs that lower low-density lipoprotein cholesterol (LDL-C) by inhibiting the PCSK9 protein, which increases the liver's ability to remove LDL-C from the blood. This intervention involves the use of established PCSK9 inhibitor agents.
| Study group | Role | What they receive |
|---|---|---|
| Standard therapy plus PCSK9 inhibitor | Experimental | Patients in the Standard therapy plus PCSK9 inhibitor group will receive a subcutaneous injection of either Evolocumab (420 mg) or Alirocumab (150 mg) within 48 hours after endovascular therapy, followed by subsequent subcutaneous injections of Evolocumab (420 mg) or Alirocumab (150 mg) every 4 weeks, for a total of 3 administrations. Receives: Drug: PCSK9 inhibitor |
| Standard therapy alone | No intervention | Patients in the Standard therapy alone (control) group will receive standard of care treatment. If low-density lipoprotein cholesterol (LDL-C) levels fail to meet target goals after 7 days, cholesterol absorption inhibitors (e.g., Ezetimibe or Hypemab) may be administered. If LDL-C levels still remain suboptimal after 1 month, PCSK9 inhibitors may be added to the treatment regimen. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome: The proportion of mordified Rankin Scale of 0 to 2 points
The proportion of mordified Rankin Scale of 0 to 2 points at 90 days
Measured: 90 days after the stroke onset
Secondary outcomes (11)
Proportion of patients with early neurological improvement
Defined as a reduction of ≥4 points on the National Institutes of Health Stroke Scale (NIHSS) score or a complete resolution of neurological deficits (NIHSS=0) within 7 days after treatment.
Measured: 7 days post-treatment
Incidence of target vessel reocclusion or recurrent infarction
Reocclusion of the responsible vessel confirmed by CTA/MRA/DSA, or new cerebral infarction in the same territory confirmed by diffusion-weighted MRI.
Measured: 90 days after the stroke onset
Reduction amplitude of low-density lipoprotein (LDL-C)
Absolute and relative reduction of LDL-C levels from baseline to Day 7.
Measured: Within 7 days post-treatment
Mortality rate
All-cause mortality at 90 days.
Measured: 90 days after the stroke onset
Incidence of symptomatic hemorrhagic transformation
Hemorrhagic transformation associated with neurological deterioration (increase in NIHSS ≥4 points) confirmed by CT or MRI.
Measured: Within 7 days post-treatment
Incidence of acute liver injury
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of normal.
Measured: Within 90 days post-treatment
Proportion of patients with early neurological deterioration
Defined as an increase of ≥4 points on the NIHSS score within 7 days post-treatment.
Measured: Within 7 days post-treatment
Distribution of modified Rankin Scale (mRS) scores
Shift analysis of mRS scores at 90 days (range 0-6).
Measured: 90 days after the stroke onset
Incidence of malignant brain edema
Defined as the presence of cerebral edema with mass effect on cranial CT or MRI within 48 to 96 hours after symptom onset, including midline shift ≥ 5 mm and/or compression of ventricles or cisterns.
Measured: 48 to 96 hours after onset
Midline shift distance
Maximum distance of midline shift (in millimeters) measured on axial CT or MRI.
Measured: 72 to 96 hours after onset
Incidence of adverse events
All adverse events and serious adverse events, recorded and graded according to CTCAE v5.0.
Measured: Within 90 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start15 Sep 2025 (estimated)
- Primary completion15 Dec 2027 (estimated)
- Study completion15 Dec 2027 (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 Nanfang Hospital, Southern Medical UniversityThe 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 478 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07174375
- Sponsor's protocol ID
- NFEC-2025-213
- Acronym
- PCSK9-PROVE
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of PCSK9 Inhibitors in Patients With Acute Ischemic Stroke Undergoing Endovascular Therapy: A Prospective, Multicenter, Open-Label, Parallel, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07174375
- Acronym / sponsor ID
- PCSK9-PROVE / NFEC-2025-213
- Conditions
- Acute Ischemic Stroke
- Keywords
- acute ischemic stroke, endovascular therapy, PCSK9 inhibitors, Lipid-Lowering Therapy, Early Artery Reocclusion
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 478 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 15 Sep 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 is a prospective, multicenter, randomized controlled clinical study to evaluate the efficacy of PCSK9 inhibitor in addition to standard therapy in patients with acute ischemic stroke undergoing endovascular therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard therapy plus PCSK9 inhibitor | Experimental | Drug: PCSK9 inhibitorPatients in the Standard therapy plus PCSK9 inhibitor group will receive a subcutaneous injection of either Evolocumab (420 mg) or Alirocumab (150 mg) within 48 hours after endovascular therapy, followed by subsequent subcutaneous injections of Evolocumab (420 mg) or Alirocumab (150 mg) every 4 weeks, for a total of 3 administrations. |
| Standard therapy alone | No intervention | –Patients in the Standard therapy alone (control) group will receive standard of care treatment. If low-density lipoprotein cholesterol (LDL-C) levels fail to meet target goals after 7 days, cholesterol absorption inhibitors (e.g., Ezetimibe or Hypemab) may be administered. If LDL-C levels still remain suboptimal after 1 month, PCSK9 inhibitors may be added to the treatment regimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years.
- Meets the diagnostic criteria for acute ischemic stroke according to the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023.
- Severe stenosis or occlusion of large anterior circulation vessels confirmed by DSA, MRA, or CTA.
- Preoperative NIHSS score ≥ 4 and < 25.
- Meets the indications for endovascular therapy per the Chinese Guidelines for Endovascular Therapy of Acute Ischemic Stroke 2023, and successful reperfusion of the target vessel (mTICI ≥ 2b) achieved via emergency endovascular intervention.
Key exclusion criteria (11 listed)
- Confirmed non-atherosclerotic causes of vascular stenosis/occlusion (e.g., cardioembolism, vasculitis, vascular malformation, moyamoya disease, iatrogenic causes).
- History of intracranial hemorrhage or systemic bleeding within the past 3 months.
- Presence of hemorrhagic transformation (PH1/PH2) immediately after the procedure.
- Severe hepatic impairment: ALT > 3 times the upper limit of normal, INR > 1.2, hepatic encephalopathy, or history of drug-induced liver injury.
- Use of PCSK9 inhibitors within 6 months prior to enrollment.
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 |
|---|---|---|
| PCSK9 inhibitorAlso: Evolocumab, AlirocumabPCSK9 (Proprotein Convertase Subtilisin/Kexin Type 9) inhibitors are a class of monoclonal antibody drugs that lower low-density lipoprotein cholesterol (LDL-C) by inhibiting the PCSK9 protein, which increases the liver's ability to remove LDL-C from the blood. This intervention involves the use of established PCSK9 inhibitor agents. | Drug | Standard therapy plus PCSK9 inhibitor |
Primary outcome
Functional outcome: The proportion of mordified Rankin Scale of 0 to 2 points
Time frame: 90 days after the stroke onset
The proportion of mordified Rankin Scale of 0 to 2 points at 90 days
11 secondary outcomes
Proportion of patients with early neurological improvement
Time frame: 7 days post-treatment
Incidence of target vessel reocclusion or recurrent infarction
Time frame: 90 days after the stroke onset
Reduction amplitude of low-density lipoprotein (LDL-C)
Time frame: Within 7 days post-treatment
Mortality rate
Time frame: 90 days after the stroke onset
Incidence of symptomatic hemorrhagic transformation
Time frame: Within 7 days post-treatment
Incidence of acute liver injury
Time frame: Within 90 days post-treatment
Proportion of patients with early neurological deterioration
Time frame: Within 7 days post-treatment
Distribution of modified Rankin Scale (mRS) scores
Time frame: 90 days after the stroke onset
Incidence of malignant brain edema
Time frame: 48 to 96 hours after onset
Midline shift distance
Time frame: 72 to 96 hours after onset
Incidence of adverse events
Time frame: Within 90 days post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- 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.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing PCSK9 inhibitor in people with Acute Ischemic Stroke, run by Nanfang Hospital, Southern Medical University at 12 sites 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 7 inclusion and 11 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: opening soon, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kaibin Huang, Ph.D. (+8615915751065, hkb@smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional outcome: The proportion of mordified Rankin Scale of 0 to 2 points (time frame: 90 days after the stroke onset). 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 15 Sep 2025.