Early Aggressive Strategy for Treatment of Lipid-Lowering in Acute Ischemic Stroke Delivered With Endovascular Therapy for Large Artery Occlusion

NCT07002476 | Recruiting Phase 3 DMC

• 1 other identifier: MA-CVD-II-001
• Study Type: interventional
• Target: 652
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective, multicenter, open-label, randomized controlled study to assess the effects of early intensive lipid-lowering initiated before endovascular treatment setting on (i) functional outcome in patients with acute ischemic stroke between preoperative intensive lipid-lowering therapy with PCSK9 inhibitor (PCSK9i) and guideline-recommended standard of care (SoC)(ii) safety in these patients.

Conditions

Stroke

Keywords

acute ischemic stroke; LDL-Cholersterol lowering; Endovascular Therapy; PCSK9; clinical trials

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 90

Secondary Outcomes (14)

• mRS ordinal score

  Day 90

• Change from baseline in NIHSS score

  Day 14±3 days or before discharge

• Change from baseline in LDL-C

  Day 14±3 days or before discharge

• Change in inflammatory markers

  Day 0, Day 14±3 days or before discharge

• Rate of severe disability(defined as mRS score of 3-5)

  Day 90

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Guideline-recommended standard of care

Drug: guideline-recommended SoC

Investigational Group

EXPERIMENTAL

Guideline-recommended standard of care+intensive lipid-lowering therapy

Drug: Recaticimab (intensive)

Interventions

guideline-recommended SoC DRUG

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.

Control Group

Recaticimab (intensive) DRUG

Recaticimab is added to the guideline-recommended SoC. After randomization and before endovascular interventional treatment, patients will receive a subcutaneous injection of Recaticimab. The specific method is: Recaticimab 450 mg (3 vials) as a single subcutaneous injection, until the end of the follow-up for this study.

Investigational Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Shanghai East Hospital: lead

Study Sites (1)

Shanghai East Hospital, Tongji University

Shanghai, 200127, China

RECRUITING

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Shanghai East Hospital

  Tongji University

  STUDY CHAIR

Central Study Contacts

Gang Li, MD

CONTACT

86021-38804518; ligang@tongji.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2025
• First Posted: June 3, 2025
• Study Start: June 19, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: January 21, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)