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Not yet taking people in ChinaPhase 4

Recaticimab for Stroke Caused by Narrowed Arteries Inside the Brain

Tests recaticimab added to standard care in people with this kind of stroke.

Plain-language title generated from the registry record
Registry title: PCSK9 Inhibitor for Intracranial Atherosclerosis Related Acute Ischemic Stroke

Key facts

Where
Baotou, Beijing, Cangzhou, Chongqing, Harbin, Jining, Liaocheng, Meizhou, Nanjing, Qingdao, Qinhuangdao, Shanghai, Shijiazhuang, Shiyan, Tangshan, Weifang, Wuhan, and Zhengzhou, ChinaSee the 19 sites
Phase
Phase 4

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 30 to 80 who had an acute ischemic stroke in the last 72 hours caused by a narrowed artery inside the brain.

Age
30 to 80 years
Sex
All sexes
Disease stage
Acute ischemic stroke that started within 72 hours before screening. NIHSS score of 4 to 25 at hospital admission. The artery that caused the stroke is narrowed by plaque (atherosclerosis) by 50% to 99%, seen on CTA, DSA or MRA.
Earlier treatment
Cannot have had a PCSK9 antibody drug within 1 month, or a PCSK9-targeting small interfering RNA therapy within 6 months, before joining. Cannot have a stent in the stroke-causing vessel before joining or planned within 3 months after joining.

Main reasons for not taking part

  • Artery narrowing from another cause, such as arterial dissection, moyamoya disease or vasculitis
  • A clear source of heart-related clots, such as atrial fibrillation, a mechanical heart valve, a clot in the left ventricle or patent foramen ovale
  • Disability before the stroke (modified Rankin Scale score of 2 or higher), or a very large stroke (ASPECTS below 6 or infarct volume of 70 mL or greater)
  • Bleeding inside the skull within 3 months before joining, or a severe bleeding or clotting disorder
  • Pregnant or breastfeeding, or planning pregnancy during the study

Read by machine on 9 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 30 and 80 years old?

Source: NCT07466251, who can take part

Where in China

  • Baotou Central HospitalBaotou, ChinaNo longer taking part
  • Chinese PLA General HospitalBeijing, ChinaNo longer taking part
  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, Beijing 100730Beijing, ChinaNo longer taking part
  • Cangzhou Hospital of Integrated Traditional Chinese and Western MedicineCangzhou, ChinaNo longer taking part
  • Chongqing General HospitalChongqing, ChinaNo longer taking part
  • First Affiliated Hospital of Harbin Medical UniversityHarbin, ChinaNo longer taking part
  • Jining First People's HospitalJining, ChinaNo longer taking part
  • Liaocheng People's HospitalLiaocheng, ChinaNo longer taking part
  • The Third Affiliated Hospital of Sun Yat-sen University, Yuedong HospitalMeizhou, ChinaNo longer taking part
  • Nanjing First HospitalNanjing, ChinaNo longer taking part
  • The Affiliated Hospital of Qingdao UniversityQingdao, ChinaNo longer taking part
  • Peking University Third Hospital Qinhuangdao HospitalQinhuangdao, ChinaNo longer taking part
  • Huashan Hospital, Fudan UniversityShanghai, ChinaNo longer taking part
  • Hebei Provincial People's HospitalShijiazhuang, ChinaNo longer taking part
  • Affiliated Taihe Hospital of Hubei University of MedicineShiyan, ChinaNo longer taking part
  • Tangshan Worker's HospitalTangshan, ChinaNo longer taking part
  • Weifang People's HospitalWeifang, ChinaNo longer taking part
  • Zhongnan Hospital of Wuhan UniversityWuhan, ChinaNo longer taking part
  • The First Affiliated Hospital of Zhengzhou UniversityZhengzhou, ChinaNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Peking Union Medical College Hospital
Trial code
NCT07466251
Record updated
15 July 2026
Original description
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.Read full original descriptionShow less

PCSK9 Inhibitor for Intracranial Atherosclerosis Related Acute Ischemic Stroke (PISTIAS-3): a Randomized, Double-blind, Placebo-controlled 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.

Inclusion: 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%.

Exclusion: Previous stent implantation in the culprit vessel or planned stent implantation in the culprit vessel within 3 months after enrollment; Any intracranial hemorrhage within 3 months before enrollment; Treatment with a PCSK9 monoclonal antibody inhibitor within 1 month before enrollment or with a PCSK9-targeting small interfering RNA therapy within 6 months before enrollment; 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; Extensive cerebral infarction on CT or MRI, such as an Alberta Stroke Program Early CT Score (ASPECTS) below 6 or an infarct volume of 70 mL or greater; Severe active bleeding tendency or coagulation disorder; Severe cardiac, hepatic, renal, or other major organ dysfunction; A definite contraindication to statin therapy or a history of statin intolerance; An intracranial tumor; or a cerebral aneurysm or arteriovenous malformation judged to require interventional treatment; Pregnant or breastfeeding, or planning to become pregnant during the study; Current participation in another clinical trial.

ClinicalTrials.gov NCT07466251