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PCSK9 Inhibitor for Intracranial Atherosclerosis Related Acute Ischemic Stroke

ConditionsAcute Ischemic Stroke AISIntracranial Atherosclerosis ICASAtherosclerotic Plaque
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age30-80
SponsorPeking Union Medical College Hospital

About this trial

This study is a prospective, multicenter, double-blind, randomized, placebo-controlled clinical trial designed to evaluate whether early administration of PCSK9 inhibitors can effectively improve functional outcomes at 90 days in patients with ischemic stroke (AIS) associated with intracranial atherosclerotic stenosis (ICAS), primarily assessed using the modified Rankin Scale at 90 days.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 30 to 80 years, inclusive.

Acute ischemic stroke with symptom onset within 72 hours before screening, diagnosed on the basis of neurological deficits and CT or MRI findings.

National Institutes of Health Stroke Scale (NIHSS) score of 4 to 25 at hospital admission.

CTA, DSA, or MRA evidence that the culprit intracranial artery has atherosclerotic stenosis of 50% to 99%.

Disqualifiers

Intracranial arterial stenosis attributable to a nonatherosclerotic cause, such as arterial dissection, moyamoya disease, or systemic vasculitis.

Any definite source of cardioembolism, such as atrial fibrillation, a mechanical prosthetic heart valve, left ventricular thrombus, or patent foramen ovale.

Clinical and imaging findings suggesting that the index ischemic event is primarily attributable to cerebral small vessel disease.

Pre-stroke disability, defined as a modified Rankin Scale score of 2 or higher before the index ischemic event.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Recaticimab plus standard therapy

    Drug

    Recaticimab (450 mg single dose, subcutaneous injection) combined with standard therapy recommended by the AHA/ASA Guidelines for Early Management of Acute Ischemic Stroke 2026 and the Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2023.

  • Recaticimab's placebo in combination with standard therapy

    Drug

    The placebo and investigational ricaximab were identical in appearance, packaging, labeling, administration method, and dosing frequency, managed through a unified production and coding system. Standard treatment followed the recommendations outlined in the "AHA/ASA Guidelines for the Early Management of Acute Ischemic Stroke 2026" and the "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023."

Treatment groups

1,212 Participants
are divided into 2 treatment groups
Group A: Recaticimab plus standard therapy groupExperimental treatment 1 intervention
Group B: Recaticimab's placebo in combination with standard therapy groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of participants with functional independence, defined as a modified Rankin Scale score of 0-2, at Day 90

The modified Rankin Scale (mRS) is a 7-category ordinal scale ranging from 0 (no symptoms) to 6 (death), with lower scores indicating better functional status. This outcome is the proportion of participants with an mRS score of 0-2, representing functional independence. Participants who die before the Day 90 assessment will be assigned an mRS score of 6. The assessment will be performed by trained assessors blinded to treatment allocation.

Time frame
Day 90 (±7 days) after randomization

Secondary outcomes

1

Proportion of participants with an excellent functional outcome, defined as an mRS score of 0-1, at Day 90

The mRS ranges from 0 (no symptoms) to 6 (death), with lower scores indicating better functional status. This outcome is the proportion of participants with an mRS score of 0-1, representing an excellent functional outcome. Participants who die before the assessment will be assigned an mRS score of 6.

Time frame
Day 90 (±7 days) after randomization
2

Distribution of modified Rankin Scale (mRS) scores at Day 90

The ordinal distribution of mRS scores across all seven categories will be assessed. The mRS ranges from 0 (no symptoms) to 6 (death), with lower scores indicating better functional status. The outcome will evaluate a shift toward better functional outcomes across the full mRS distribution.

Time frame
Day 90 (±7 days) after randomization
3

Incidence of any stroke through Day 90

Proportion of participants who experience an adjudicated stroke after randomization, including either ischemic stroke or hemorrhagic stroke. Suspected events will be reviewed by an independent Clinical Event Committee blinded to treatment allocation.

Time frame
From randomization through Day 90
4

Incidence of ischemic stroke through Day 90

Proportion of participants who experience an adjudicated ischemic stroke after randomization. Ischemic stroke is defined as a new focal neurological injury attributable to cerebral ischemia, supported by clinical findings and/or imaging evidence of acute cerebral infarction, and not explained by a nonischemic cause. Events will be adjudicated by an independent blinded Clinical Event Committee.

Time frame
From randomization through Day 90

Other outcomes

1

Change from baseline in NIHSS score at 24 hours

Change in NIHSS score will be calculated as the 24-hour NIHSS score minus the baseline NIHSS score. The NIHSS ranges from 0 to 42, with higher scores indicating greater neurological impairment. A negative change indicates neurological improvement.

Time frame
From baseline to 24 hours after randomization, with an allowable assessment window of -2 to +12 hours
2

Cerebral infarct volume at Day 7 or hospital discharge

Cerebral infarct volume will be quantified in milliliters using follow-up CT or MRI and assessed by a blinded core imaging laboratory. Lower infarct volumes indicate less extensive ischemic brain injury.

Time frame
Day 7 (±2 days) after randomization or at hospital discharge, whichever occurs first
3

Cerebral perfusion parameters at Day 7 or hospital discharge

Prespecified quantitative cerebral perfusion parameters derived from CT perfusion or MR perfusion imaging will be assessed by a blinded core imaging laboratory.

Time frame
Day 7 (±2 days) after randomization or at hospital discharge, whichever occurs first
4

Serum interleukin-6 concentration at Day 7 or hospital discharge

Serum interleukin-6 concentration will be measured as a marker of systemic inflammation. Higher concentrations indicate greater inflammatory activity. Testing will be performed according to the prespecified laboratory procedures.

Time frame
Day 7 (±2 days) after randomization or at hospital discharge, whichever occurs first

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking Union Medical College Hospital

Lead sponsor

Chinese PLA General Hospital

Collaborator

Hebei General Hospital

Collaborator

Taihe Hospital

Collaborator

Weifang People's Hospital

Collaborator

Nanjing First Hospital, Nanjing Medical University

Collaborator

Baotou Central Hospital

Collaborator

Jining First People's Hospital

Collaborator

Liaocheng People's Hospital

Collaborator

Tangshan Worker's Hospital

Collaborator

Chongqing General Hospital

Collaborator

First Affiliated Hospital of Harbin Medical University

Collaborator

Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

Collaborator

The First Affiliated Hospital of Zhengzhou University

Collaborator

The Affiliated Hospital of Qingdao University

Collaborator

Zhongnan Hospital

Collaborator

Huashan Hospital

Collaborator

Source ClinicalTrials.gov

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