StrokePhase 3EAST-LDLNCT07002476
Early Aggressive Strategy for Treatment of Lipid-Lowering in Acute Ischemic Stroke Delivered With Endovascular Therapy for Large Artery Occlusion
A Phase 3 study testing guideline-recommended SoC and Recaticimab (intensive) in people with Stroke, run by Shanghai East Hospital at 1 site in China.
Trial summary
EAST-LDL is a prospective, multicenter, randomized, open-label clinical trial with blinded endpoint assessment evaluating whether early intensive lipid lowering with the PCSK9 inhibitor recaticimab, administered before endovascular therapy, improves functional outcome in patients with acute ischemic stroke due to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- guideline-recommended SoC and Recaticimab (intensive)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 978 participants
- Where
- 1 siteChina
- Study dates
- 19 Jun 2025to 1 Jun 2027
- Phase
- Phase 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
- Adults (age 18 years and older);
- Imaging diagnosis of acute ischemic stroke with anterior circulation large vessel occlusion (including: internal carotid artery, middle cerebral artery M1 and M2, anterior cerebral artery A1 and A2);
- Planned to undergo endovascular intervention within 24 hours of symptom onset (or last known well time) according to local guidelines;
- Provision of informed consent by the patient or his/her legally authorized representative (or by an appropriate agent according to local requirements).
Who cannot join
- ASPECTS score ≤5 on cranial CT imaging;
- Pre-existing functional impairment, with mRS score >2;
- Patients who are allergic to PCSK9 inhibitors;
- Patients who have received PCSK9 monoclonal antibody within 1 month prior to enrollment or PCSK9 siRNA therapy within 6 months prior to enrollment;
- Severe renal insufficiency, defined as estimated glomerular filtration rate (eGFR) < 15 mL/min/1.73m2 at final screening;
- Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the upper limit of normal;
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- Severe, concomitant non-cardiovascular disease expected to reduce life expectancy to less than 3 months;
- Pregnant or lactating women;
- Patients who are participating in other clinical trials;
- Other conditions deemed unsuitable for inclusion in the clinical study by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai East Hospital, Tongji University
Shanghai, 200127
Gang Li, MD, 86021-38804518 ext. 22107, ligang@tongji.edu.cn
About this study
EAST-LDL is a prospective, multicenter, randomized, open-label clinical trial with blinded endpoint assessment evaluating whether early intensive lipid lowering with the PCSK9 inhibitor recaticimab, administered before endovascular therapy, improves functional outcome in patients with acute ischemic stroke due to anterior-circulation large-vessel occlusion. Participants are randomized to recaticimab plus guideline-recommended standard of care or standard of care alone. The primary outcome is favorable functional outcome, defined as a modified Rankin Scale score of 0-2 at 90 ± 7 days.
Read the detailed description
EAST-LDL is an investigator-initiated, prospective, multicenter, randomized, open-label clinical trial with blinded endpoint assessment conducted at approximately 20 stroke centers in China. Adults with acute ischemic stroke due to anterior-circulation large-vessel occlusion who are planned to undergo endovascular therapy within 24 hours of symptom onset or last known well are randomized 1:1 to the PCSK9 inhibitor group or the control group. Participants assigned to the PCSK9 inhibitor group receive guideline-recommended standard of care plus recaticimab 450 mg administered subcutaneously after randomization and before the first thrombectomy pass, whereas participants assigned to the control group receive guideline-recommended standard of care alone.
The original target sample size was 652 participants. The protocol prespecified one sample-size re-estimation after approximately 50% of the initially planned participants had completed the 90-day primary outcome assessment. Following the prespecified re-estimation, the independent Data and Safety Monitoring Board recommended at its third meeting on August 3, 2026 that the total sample size be increased by 50%, from 652 to 978 participants, in accordance with the predefined adaptive rules. No unblinded treatment results were disclosed to the investigators or other members of the blinded study team. The current target sample size is therefore 978 participants.
The primary outcome is favorable functional outcome at 90 ± 7 days, defined as a modified Rankin Scale (mRS) score of 0-2. Secondary efficacy outcomes include the ordinal distribution of mRS scores, National Institutes of Health Stroke Scale (NIHSS) score and change from baseline, low-density lipoprotein cholesterol (LDL-C) goal attainment and change from baseline, changes in inflammatory markers, severe disability, all-cause mortality, recurrent ischemic stroke, new hemorrhagic stroke, major adverse cardiovascular events, and health-related quality of life assessed using the EuroQol 5-Dimension questionnaire. Safety outcomes include symptomatic intracranial hemorrhagic transformation, serious adverse events, and adverse events of special interest. The 90-day mRS outcome is assessed centrally by an independent Outcome Assessment Committee blinded to treatment allocation.
- Conditions
- Stroke
- Being tested
- guideline-recommended SoC, Recaticimab (intensive)
- Keywords
- acute ischemic stroke, LDL-Cholersterol lowering, Endovascular Therapy, PCSK9, clinical trials
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
guideline-recommended SoCDrug
Guideline-recommended SoC, including but not limited to oral lipid-lowering drugs, antiplatelet aggregation drugs, anticoagulant drugs, antihypertensive drugs, etc. It is to be determined by the investigator based on the subject's treatment needs.
Recaticimab (intensive)Drug
450 mg as three 150-mg subcutaneous injections after randomization and before the first thrombectomy pass. No additional PCSK9 inhibitor treatment is planned during the 90-day follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Guideline-recommended standard of care Receives: Drug: guideline-recommended SoC |
| Investigational Group | Experimental | Guideline-recommended standard of care+intensive lipid-lowering therapy Receives: Drug: Recaticimab (intensive) |
What is being measured
The primary outcome is the main question the study is designed to answer.
favorable functional outcome (defined as an mRS score of 0-2)
the rate (%) of good functional outcome at 90 days (modified Rankin Scale [mRS] score 0-2). Modified Rankin Scale scores of 0 or 1 indicate good function without or with symptoms but not disability, score of 2 indicates slight disability but independence, 3 to 5 indicate increasing levels of disability (and dependency), and a score of 6 indicates death.
Measured: 90 ± 7 days
Secondary outcomes (14)
mRS ordinal score
Modified Rankin Scale scores of 0 or 1 indicate good function without or with symptoms but not disability, score of 2 indicates slight disability but independence, 3 to 5 indicate increasing levels of disability (and dependency), and a score of 6 indicates death.
Measured: 90 ± 7 days
Change from baseline in NIHSS score
0-42, higher scores indicates worse severity
Measured: Day 14±3 days or before discharge
Change from baseline in LDL-C
Change from baseline in LDL-C at 14±3 days or before discharge
Measured: Day 14±3 days or before discharge
Change in inflammatory markers
Change from baseline in inflammatory markers at 14±3 days or before discharge;
Measured: Day 0, Day 14±3 days or before discharge
Rate of severe disability(defined as mRS score of 3-5)
Modified Rankin Scale scores of 0 or 1 indicate good function without or with symptoms but not disability, score of 2 indicates slight disability but independence, 3 to 5 indicate increasing levels of disability (and dependency), and a score of 6 indicates death.
Measured: 90 ± 7 days
Incidence of recurrent ischemic stroke events
Incidence of recurrent ischemic stroke events
Measured: From randomization through Day 90
Incidence of symptomatic intracranial hemorrhage transformation
Incidence of symptomatic intracranial hemorrhage transformation within 24-48h;
Measured: Within 24-48 hours
Incidence of patients with new hemorrhagic stroke
Incidence of patients with new hemorrhagic stroke
Measured: From randomization through Day 90
Incidence of patients with major adverse cardiovascular events
Incidence of major adverse cardiovascular events (MACEs) within 90 days
Measured: From randomization through Day 90
Number of patients with serious adverse events
total number of serious adverse events reported during follow-up, according to standard definitions
Measured: From enrollment to 90 days
Health related quality of life
according to the EQ-5D
Measured: 90 ± 7 days
NIHSS score
0-42, higher scores indicates worse severity
Measured: at 14±3 days or before discharge
LDL-C goal attainment rate
LDL-C attained equal or lower than 1.8mmol/L (70 mg/dL)
Measured: at 14±3 days or before discharge
Mortality rate
Death within 90 days.
Measured: 90 ± 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start19 Jun 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 978 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shanghai East Hospital, Study chair, Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07002476
- Sponsor's protocol ID
- MA-CVD-II-001
- Acronym
- EAST-LDL
- Status last verified
- Aug 2026
- First submitted
- 25 May 2025
- Last updated
- 2 Sep 2026
- 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 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Aggressive Strategy for Treatment of Lipid-Lowering in Acute Ischemic Stroke Delivered With Endovascular Therapy for Large Artery Occlusion
- ClinicalTrials.gov ID
- NCT07002476
- Acronym / sponsor ID
- EAST-LDL / MA-CVD-II-001
- Conditions
- Stroke
- Keywords
- acute ischemic stroke, LDL-Cholersterol lowering, Endovascular Therapy, PCSK9, clinical trials
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 978 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Study start
- 19 Jun 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 3 Jun 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.
EAST-LDL is a prospective, multicenter, randomized, open-label clinical trial with blinded endpoint assessment evaluating whether early intensive lipid lowering with the PCSK9 inhibitor recaticimab, administered before endovascular therapy, improves functional outcome in patients with acute ischemic stroke due to anterior-circulation large-vessel occlusion. Participants are randomized to recaticimab plus guideline-recommended standard of care or standard of care alone. The primary outcome is favorable functional outcome, defined as a modified Rankin Scale score of 0-2 at 90 ± 7 days.
Detailed description
EAST-LDL is an investigator-initiated, prospective, multicenter, randomized, open-label clinical trial with blinded endpoint assessment conducted at approximately 20 stroke centers in China. Adults with acute ischemic stroke due to anterior-circulation large-vessel occlusion who are planned to undergo endovascular therapy within 24 hours of symptom onset or last known well are randomized 1:1 to the PCSK9 inhibitor group or the control group. Participants assigned to the PCSK9 inhibitor group receive guideline-recommended standard of care plus recaticimab 450 mg administered subcutaneously after randomization and before the first thrombectomy pass, whereas participants assigned to the control group receive guideline-recommended standard of care alone.
The original target sample size was 652 participants. The protocol prespecified one sample-size re-estimation after approximately 50% of the initially planned participants had completed the 90-day primary outcome assessment. Following the prespecified re-estimation, the independent Data and Safety Monitoring Board recommended at its third meeting on August 3, 2026 that the total sample size be increased by 50%, from 652 to 978 participants, in accordance with the predefined adaptive rules. No unblinded treatment results were disclosed to the investigators or other members of the blinded study team. The current target sample size is therefore 978 participants.
The primary outcome is favorable functional outcome at 90 ± 7 days, defined as a modified Rankin Scale (mRS) score of 0-2. Secondary efficacy outcomes include the ordinal distribution of mRS scores, National Institutes of Health Stroke Scale (NIHSS) score and change from baseline, low-density lipoprotein cholesterol (LDL-C) goal attainment and change from baseline, changes in inflammatory markers, severe disability, all-cause mortality, recurrent ischemic stroke, new hemorrhagic stroke, major adverse cardiovascular events, and health-related quality of life assessed using the EuroQol 5-Dimension questionnaire. Safety outcomes include symptomatic intracranial hemorrhagic transformation, serious adverse events, and adverse events of special interest. The 90-day mRS outcome is assessed centrally by an independent Outcome Assessment Committee blinded to treatment allocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Drug: guideline-recommended SoCGuideline-recommended standard of care |
| Investigational Group | Experimental | Drug: Recaticimab (intensive)Guideline-recommended standard of care+intensive lipid-lowering therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (age 18 years and older);
- Imaging diagnosis of acute ischemic stroke with anterior circulation large vessel occlusion (including: internal carotid artery, middle cerebral artery M1 and M2, anterior cerebral artery A1 and A2);
- Planned to undergo endovascular intervention within 24 hours of symptom onset (or last known well time) according to local guidelines;
- Provision of informed consent by the patient or his/her legally authorized representative (or by an appropriate agent according to local requirements).
Key exclusion criteria (10 listed)
- ASPECTS score ≤5 on cranial CT imaging;
- Pre-existing functional impairment, with mRS score >2;
- Patients who are allergic to PCSK9 inhibitors;
- Patients who have received PCSK9 monoclonal antibody within 1 month prior to enrollment or PCSK9 siRNA therapy within 6 months prior to enrollment;
- Severe renal insufficiency, defined as estimated glomerular filtration rate (eGFR) < 15 mL/min/1.73m2 at final screening;
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 |
|---|---|---|
| guideline-recommended SoCGuideline-recommended SoC, including but not limited to oral lipid-lowering drugs, antiplatelet aggregation drugs, anticoagulant drugs, antihypertensive drugs, etc. It is to be determined by the investigator based on the subject's treatment needs. | Drug | Control Group |
| Recaticimab (intensive)450 mg as three 150-mg subcutaneous injections after randomization and before the first thrombectomy pass. No additional PCSK9 inhibitor treatment is planned during the 90-day follow-up. | Drug | Investigational Group |
Primary outcome
favorable functional outcome (defined as an mRS score of 0-2)
Time frame: 90 ± 7 days
the rate (%) of good functional outcome at 90 days (modified Rankin Scale [mRS] score 0-2). Modified Rankin Scale scores of 0 or 1 indicate good function without or with symptoms but not disability, score of 2 indicates slight disability but independence, 3 to 5 indicate increasing levels of disability (and dependency), and a score of 6 indicates death.
14 secondary outcomes
mRS ordinal score
Time frame: 90 ± 7 days
Change from baseline in NIHSS score
Time frame: Day 14±3 days or before discharge
Change from baseline in LDL-C
Time frame: Day 14±3 days or before discharge
Change in inflammatory markers
Time frame: Day 0, Day 14±3 days or before discharge
Rate of severe disability(defined as mRS score of 3-5)
Time frame: 90 ± 7 days
Incidence of recurrent ischemic stroke events
Time frame: From randomization through Day 90
Incidence of symptomatic intracranial hemorrhage transformation
Time frame: Within 24-48 hours
Incidence of patients with new hemorrhagic stroke
Time frame: From randomization through Day 90
Incidence of patients with major adverse cardiovascular events
Time frame: From randomization through Day 90
Number of patients with serious adverse events
Time frame: From enrollment to 90 days
Health related quality of life
Time frame: 90 ± 7 days
NIHSS score
Time frame: at 14±3 days or before discharge
LDL-C goal attainment rate
Time frame: at 14±3 days or before discharge
Mortality rate
Time frame: 90 ± 7 days
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 2 Sep 2026.
- 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.
Shanghai East Hospital study chair
Tongji University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing guideline-recommended SoC and Recaticimab (intensive) in people with Stroke, run by Shanghai East Hospital 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 4 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: looking for participants now, as of the sponsor's last update on 2 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 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 Gang Li, MD (86021-38804518 ext. 22107, ligang@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
favorable functional outcome (defined as an mRS score of 0-2) (time frame: 90 ± 7 days). 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 2 Sep 2026.