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PCSK9-hæmmer til intrakraniel aterosklerose-relateret akut iskæmisk apopleksi (PISTIAS-3)

14. juli 2026 opdateret af: Wei-Hai Xu, Peking Union Medical College Hospital

PCSK9-hæmmer til intrakraniel aterosklerose-relateret akut iskæmisk apopleksi (PISTIAS-3): et randomiseret, dobbeltblindet, placebokontrolleret forsøg

Denne undersøgelse er en prospektiv, multicenter, dobbeltblind, randomiseret, placebo-kontrolleret klinisk prøve, der er designet til at evaluere, om tidlig administration af PCSK9-hæmmere effektivt kan forbedre funktionelle resultater efter 90 dage hos patienter med iskæmisk apopleksi (AIS) forbundet med intrakraniell aterosklerotisk stenose (ICAS), primært vurderet ved hjælp af den modificerede Rankin-skala efter 90 dage.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Akut iskæmisk apopleksi (AIS) forbliver en af de førende døds- og invaliditetsårsager globalt. Selvom intravenøs trombolyse og endovaskulære terapier har forbedret reperfusionssuccesraterne betydeligt, består der i klinisk praksis tre kritiske udfordringer, der bestemmer prognosen: For det første kan kun en begrænset andel af patienter faktisk modtage reperfusionsterapi inden for det terapeutiske tidsvindue; For det andet kan der selv ved vellykket reperfusion stadig forekomme sekundære skader såsom mikrocirkulatorisk perfusionssvigt, inflammatoriske kaskader og trombusdannelse på ny. For det tredje forbliver akutfaseudsving, især tidlig neurologisk forværring og risikoen for tidlig recidiv, fremtrædende, hvilket direkte begrænser forbedringer i funktionelle resultater. 3 Intrakraniel aterosklerotisk stenose (ICAS) udgør op til 50% af etiologierne for iskæmisk apopleksi i Kina. Dens patologiske kæde-"plaqueinstabilitet-trombose-mikrocirkulatorisk svigt"-gennemtrænger både den akutte og subakutte fase og korrelerer tæt med tidlig recidiv og dårlige resultater.Proprotein convertase subtilisin/kexin type 9 (PCSK9) fremmer klassisk nedbrydningen af low-density lipoprotein kolesterol (LDL-C) receptorer og øger LDL-C-niveauer, hvilket derved driver aterosklerosefremgangen. Endnu vigtigere, voksende grundlæggende og translationsforskning antyder, at PCSK9 muligvis ikke kun fungerer som et "lipidstofskifteprotein", men også deltager i processer såsom endotelaktivering, inflammatoriske kaskader, trombocytreaktivitet og mikrocirkulatorisk dysfunktion. Dette positionerer det som et potentielt knudepunkt, der forbinder "plaque-trombus-inflammation"-aksen. Følgelig kan PCSK9-hæmmere tilbyde yderligere nevrovaskulære beskyttelsesfordele ud over lipidnedsættende effekter under den akutte fase af akut iskæmisk apopleksi (AIS).Eksisterende grundlæggende og klinisk evidens antyder, at PCSK9-hæmmere kan udøve en kombineret interventionseffekt på nøglepatologiske processer, der driver aterosklerose under den akutte fase af AIS, gennem en dual mekanisme, der involverer både lipidafhængige og ikke-lipidafhængige veje. Mekanistiske undersøgelser afslører, at PCSK9-hæmning samtidig modulerer inflammatoriske responser, endotelaktivering, dysfunktion og trombogen tendens. I iskæmi-reperfusionsmodeller demonstrerer det neuroprotektiv signalering ved at mindske hjerneskade og forbedre neurologisk funktion. Klinisk bekræfter store randomiserede forsøg dens evne til hurtigt at forbedre lipidnedsættende effekter ud over statiner og reducere risikoen for iskæmisk apopleksi. Yderligere translationsbevis i cerebrovaskulær sygdom indikerer, at i symptomatiske ICAS-populationer reducerer PCSK9-hæmmer plus statin-forstærket lipidnedsættende terapi plakkebyrd, lindrer stenose og øger plakkestabilitet. I den akutte fase af AIS korrelerer tidlig tilføjelse af PCSK9-hæmmere med reduceret neurologisk forværring inden for 7 dage, reduceret recidivrisiko inden for 30 dage og forbedrede funktionelle resultater ved 90 dage. Samlet set leverer denne evidenskæde, der spænder fra mekanismer til klinisk praksis, klar videnskabelig begrundelse og klinisk nødvendighed for at tilføje PCSK9-hæmmere til behandlingen af ICAS-associeret AIS.Denne undersøgelse er en landsdækkende, prospektiv, multicenter, dobbeltblind, randomiseret, placebo-kontrolleret klinisk prøve. Den vil inkludere 1.212 patienter, der opfylder inklusions- og eksklusionskriterier. Patienter vil blive tilfældigt tildelt to grupper ved hjælp af en randomiseret allokeringsmetode: (1) Eksperimentel gruppe: 450 mg Recaticimab til injektion (3 hætteglas) administreret som en enkelt subkutan injektion. (2) Kontrolgruppe: Placebo af Recaticimab til injektion 450 mg (3 hætteglas) administreret som en enkelt subkutan injektion. Hver gruppe vil inkludere 606 patienter. Begge grupper vil modtage standard retningslinjeanbefalet behandling ud over undersøgelsesmedicinen. Langtidsvirkning blev vurderet gennem patientbesøg og evalueringer ved 0 timer, 24 timer (±2 eller ±12 timer), 7 dage (±2 dage) eller ved udskrivelse, 90 dage (±7 dage) og 1 år.Primære resultatmål inkluderede: Analyse baseret på intention-to-treat-princippet ved hjælp af en ANCOVA-model for alle randomiserede patienter med baseline HRMRI og en modificeret Rankin Skala (mRS) score på 0-2 ved 90 dage. Sekundære resultatmål inkluderede: (1) mRS score på 0-1 ved 90 dage (angiver god patientfunktion); (2) Fordeling af 90-dages mRS scores; (3) Enhver apopleksi (inklusive iskæmisk og hæmoragisk) inden for 90 dage; (4) Iskæmisk apopleksi inden for 90 dage; (5) Sammensatte vaskulære hændelser (inklusive apopleksi, myokardieinfarkt og vaskulær død) inden for 90 dage; (6) 90-dages European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) score; (7) 90-dages Barthel Index (BI) score.Detaljer er angivet i "Outcome Measures"-sektionen.Stikprøvestørrelsen er beregnet baseret på det primære resultat, og der forventes i alt 1212 deltagere. Et uafhængigt Data Safety Monitoring Board vil overvåge den samlede gennemførelse af forsøget.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

1212

Fase

Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Navn: Yiyang Liu, PhD
Telefonnummer: 86+13938912070
E-mail: liuyydoct@163.com

Undersøgelse Kontakt Backup

Navn: Weihai Xu, MD
Telefonnummer: 86+13938912070
E-mail: xuwh@pumch.cn

Studiesteder

Kina
- - Beijing, Kina
    - Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, Beijing 100730
    - Kontakt:
      
      Weihai Xu, MD
      
      Telefonnummer: 86+13651147766
      
      E-mail: xuwh@pumch.cn
    - Ledende efterforsker:
      
      Weihai Xu, MD
  - Chongqing, Kina
    - Chongqing General Hospital
  - Shanghai, Kina
    - Huashan Hospital, Fudan University
- Beijing Municipality
  - Beijing, Beijing Municipality, Kina, 100853
    - Chinese PLA General Hospital
    - Kontakt:
      
      Shiwen Wu, MD
      
      Telefonnummer: 86+13910238117
      
      E-mail: wu_shiwen@outlook.com
    - Ledende efterforsker:
      
      Shiwen Wu, MD
- Guangdong
  - Meizhou, Guangdong, Kina
    - The Third Affiliated Hospital of Sun Yat-sen University, Yuedong Hospital
- Hebei
  - Cangzhou, Hebei, Kina
    - Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
  - Qinhuangdao, Hebei, Kina
    - Peking University Third Hospital Qinhuangdao Hospital
  - Shijiazhuang, Hebei, Kina, 050051
    - Hebei Provincial People's Hospital
  - Tangshan, Hebei, Kina, 063000
    - Tangshan Worker's Hospital
    - Kontakt:
      
      Baoquan Lu
      
      Telefonnummer: 13930565557
      
      E-mail: balcom@163.com
    - Ledende efterforsker:
      
      Baoquan Lu, MD
- Heilongjiang
  - Harbin, Heilongjiang, Kina
    - First Affiliated Hospital of Harbin Medical University
- Henan
  - Zhengzhou, Henan, Kina
    - The First Affiliated Hospital of Zhengzhou University
- Hubei
  - Shiyan, Hubei, Kina
    - Affiliated Taihe Hospital of Hubei University of Medicine
  - Wuhan, Hubei, Kina
    - Zhongnan Hospital of Wuhan University
- Inner Mongolia
  - Baotou, Inner Mongolia, Kina, 014000
    - Baotou Central Hospital
- Jiangsu
  - Nanjing, Jiangsu, Kina, 210000
    - Nanjing First Hospital
- Shandong
  - Jining, Shandong, Kina, 272000
    - Jining First People's Hospital
  - Liaocheng, Shandong, Kina, 252000
    - Liaocheng People's Hospital
  - Qingdao, Shandong, Kina
    - The Affiliated Hospital of Qingdao University
  - Weifang, Shandong, Kina, 261000
    - Weifang People's Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Voksen
Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

Alder >=30 og <=80;2.Akut iskæmisk apopleksi inden for 72 timer efter debut (fastsat ved CT/MRI i kombination med neurologiske deficitsymptomer)
Akut iskæmisk apopleksi inden for 72 timer efter debut (diagnosticeret ved CT/MRI i kombination med neurologiske deficitsymptomer)
NIHSS-score på 4-25 ved indlæggelse
Billeddiagnostiske undersøgelser (CTA/DSA/MRA) understøtter intrakraniell aterosklerose som årsag til apopleksi, der opfylder et af følgende kriterier: i. Den skyldige blodåre udviser intrakraniell aterosklerotisk stenose (ICAS) med en indsnævring på 50-99%; ii. Den skyldige blodåre udviser intrakraniell aterosklerotisk okklusion (ICAS-LVO), med succesfuld rekanalisering opnået via mekanisk trombektomi (umiddelbar udvidet trombolyse i cerebral infarkt [eTICI] grad 2b50-3)
Informert samtykke underskrevet

Eksklusionskriterier:

Ikke-aterosklerotisk intrakraniell arteriel stenose (såsom arteriedissektion, Moyamoya-sygdom, systemisk vaskulitis, etc.)
Enhver identificerbar kilde til kardiogen emboli (såsom atrieflimren, mekaniske klapper, venstre ventrikel trombus, åbent foramen ovale, etc.)
Billeddiagnostiske fund og klinisk præsentation tyder på, at den primære patofysiologi ved denne begivenhed er mere i overensstemmelse med cerebral lillekarssygdom (f.eks. perforatorarterieokklusion/lakunær infarkt)
Forudgående funktionsnedsættelse før denne iskæmiske begivenhed (modificeret Rankin-skala ≥ 2 point)
CT- eller MRI-fund tyder på omfattende cerebral infarkt (f.eks. ASPECTS-score < 6 eller infarktvolumen ≥ 70 ml)
Har gennemgået eller er planlagt til at gennemgå en procedure med vaskulær stentimplantation inden for de næste tre måneder
Enhver intrakraniell blødning, der er opstået inden for 3 måneder før inklusion;
Intrakranielle tumorer, cerebrale aneurismer eller arteriovenøse misdannelser, der vurderes til at have indikationer for interventionel behandling
Alvorlig aktiv blødningstendens eller koagulationsforstyrrelse
Alvorlig dysfunktion af vitale organer såsom hjerte, lever og nyrer
Har modtaget PCSK9 monoklonalt antistof inhibitorbehandling inden for 1 måned før inklusion eller PCSK9 siRNA inhibitorbehandling inden for 6 måneder før inklusion
En klar kontraindikation mod statiner eller en historie med intolerance over for dem
Graviditet, amning eller planlægning af graviditet;14.Deltager i øjeblikket i et andet studie

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Randomiseret
Interventionel model: Parallel tildeling
Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm Deltagergruppe / Arm En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.	Intervention / Behandling Intervention / Behandling En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Eksperimentel: Recaticimab plus standardbehandlingsgruppe Recaticimab i kombination med standardbehandling	Medicin: Recaticimab plus standard therapy 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.
Placebo komparator: Recaticimab's placebo in combination with standard therapy group Recaticimab's placebo in combination with standard therapy	Medicin: Recaticimab's placebo in combination with standard therapy 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."

Deltagergruppe / Arm

Intervention / Behandling

Eksperimentel: Recaticimab plus standardbehandlingsgruppe

Recaticimab i kombination med standardbehandling

Medicin: Recaticimab plus standard therapy

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.

Placebo komparator: Recaticimab's placebo in combination with standard therapy group

Recaticimab's placebo in combination with standard therapy

Medicin: Recaticimab's placebo in combination with standard therapy

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."

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Proportion of participants with functional independence, defined as a modified Rankin Scale score of 0-2, at Day 90 Tidsramme: Day 90 (±7 days) after randomization	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.	Day 90 (±7 days) after randomization

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Proportion of participants with an excellent functional outcome, defined as an mRS score of 0-1, at Day 90 Tidsramme: Day 90 (±7 days) after randomization	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.	Day 90 (±7 days) after randomization
Distribution of modified Rankin Scale (mRS) scores at Day 90 Tidsramme: Day 90 (±7 days) after randomization	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.	Day 90 (±7 days) after randomization
Incidence of any stroke through Day 90 Tidsramme: From randomization 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.	From randomization through Day 90
Incidence of ischemic stroke through Day 90 Tidsramme: From randomization 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.	From randomization through Day 90
Incidence of composite vascular events through Day 90 Tidsramme: From randomization through Day 90	Proportion of participants who experience at least one component of the composite endpoint after randomization. The composite endpoint includes any stroke, myocardial infarction, or vascular death. Events will be adjudicated by an independent Clinical Event Committee blinded to treatment allocation.	From randomization through Day 90
Barthel Index score at Day 90 Tidsramme: Day 90 (±7 days) after randomization	Activities of daily living will be assessed using the Barthel Index. The total score ranges from 0 to 100, with higher scores indicating greater independence in activities of daily living and better functional status.	Day 90 (±7 days) after randomization
Health-related quality of life assessed using the EQ-5D-5L at Day 90 Tidsramme: Day 90 (±7 days) after randomization	Health-related quality of life will be assessed using the European Quality of Life 5-Dimension 5-Level instrument. The descriptive system assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with five levels of severity for each dimension. Overall self-rated health will also be assessed using the EQ visual analogue scale, ranging from 0 (worst imaginable health) to 100 (best imaginable health).	Day 90 (±7 days) after randomization
National Institutes of Health Stroke Scale score at Day 7 or hospital discharge Tidsramme: Day 7 (±2 days) after randomization or at hospital discharge, whichever occurs first	Neurological impairment will be assessed using the National Institutes of Health Stroke Scale (NIHSS). The NIHSS ranges from 0 to 42, with higher scores indicating greater neurological impairment.	Day 7 (±2 days) after randomization or at hospital discharge, whichever occurs first
Change from baseline in NIHSS score at Day 7 or hospital discharge Tidsramme: From baseline to Day 7 (±2 days) after randomization or hospital discharge, whichever occurs first	Change in NIHSS score will be calculated as the follow-up 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, whereas a positive change indicates neurological worsening.	From baseline to Day 7 (±2 days) after randomization or hospital discharge, whichever occurs first
Proportion of participants achieving an LDL-C level below 1.4 mmol/L at Day 7 or hospital discharge Tidsramme: Day 7 (±2 days) after randomization or at hospital discharge, whichever occurs first	Proportion of participants whose measured low-density lipoprotein cholesterol (LDL-C) concentration is below 1.4 mmol/L at the scheduled assessment.	Day 7 (±2 days) after randomization or at hospital discharge, whichever occurs first
Proportion of participants achieving an LDL-C level below 1.8 mmol/L at Day 7 or hospital discharge Tidsramme: Day 7 (±2 days) after randomization or at hospital discharge, whichever occurs first	Proportion of participants whose measured low-density lipoprotein cholesterol (LDL-C) concentration is below 1.8 mmol/L at the scheduled assessment.	Day 7 (±2 days) after randomization or at hospital discharge, whichever occurs first
Change from baseline in LDL-C level at Day 7 or hospital discharge Tidsramme: From baseline to Day 7 (±2 days) after randomization or hospital discharge, whichever occurs first	Change in LDL-C concentration will be calculated as the follow-up LDL-C value minus the baseline value and reported in mmol/L. A negative value indicates a reduction in LDL-C from baseline.	From baseline to Day 7 (±2 days) after randomization or hospital discharge, whichever occurs first

Andre resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Change from baseline in NIHSS score at 24 hours Tidsramme: From baseline to 24 hours after randomization, with an allowable assessment window of -2 to +12 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.	From baseline to 24 hours after randomization, with an allowable assessment window of -2 to +12 hours
Cerebral infarct volume at Day 7 or hospital discharge Tidsramme: Day 7 (±2 days) after randomization or at hospital discharge, whichever occurs first	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.	Day 7 (±2 days) after randomization or at hospital discharge, whichever occurs first
Cerebral perfusion parameters at Day 7 or hospital discharge Tidsramme: Day 7 (±2 days) after randomization or at hospital discharge, whichever occurs first	Prespecified quantitative cerebral perfusion parameters derived from CT perfusion or MR perfusion imaging will be assessed by a blinded core imaging laboratory.	Day 7 (±2 days) after randomization or at hospital discharge, whichever occurs first
Serum interleukin-6 concentration at Day 7 or hospital discharge Tidsramme: Day 7 (±2 days) after randomization or at hospital discharge, whichever occurs first	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.	Day 7 (±2 days) after randomization or at hospital discharge, whichever occurs first
High-sensitivity C-reactive protein concentration at Day 7 or hospital discharge Tidsramme: Day 7 (±2 days) after randomization or at hospital discharge, whichever occurs first	High-sensitivity C-reactive protein concentration will be measured as a marker of systemic inflammation. Higher concentrations indicate greater inflammatory activity.	Day 7 (±2 days) after randomization or at hospital discharge, whichever occurs first
Incidence of any stroke through 1 year Tidsramme: From randomization through 1 year	Proportion of participants who experience an adjudicated ischemic or hemorrhagic stroke after randomization. Events will be reviewed by an independent Clinical Event Committee blinded to treatment allocation.	From randomization through 1 year
Incidence of ischemic stroke through 1 year Tidsramme: From randomization through 1 year	Proportion of participants who experience an adjudicated ischemic stroke after randomization. Events will be reviewed by an independent Clinical Event Committee blinded to treatment allocation.	From randomization through 1 year
Incidence of composite vascular events through 1 year Tidsramme: From randomization through 1 year	Proportion of participants who experience at least one component of the composite endpoint, defined as any stroke, myocardial infarction, or vascular death. Events will be adjudicated by an independent blinded Clinical Event Committee.	From randomization through 1 year
Health-related quality of life assessed using the EQ-5D-5L at 1 year Tidsramme: At 1 year after randomization	Health-related quality of life will be assessed using the EQ-5D-5L descriptive system, covering mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Overall self-rated health will also be assessed using the EQ visual analogue scale ranging from 0 to 100, with higher scores indicating better perceived health.	At 1 year after randomization
Barthel Index score at 1 year Tidsramme: At 1 year after randomization	Activities of daily living will be assessed using the Barthel Index. The total score ranges from 0 to 100, with higher scores indicating greater independence and better functional status.	At 1 year after randomization
Incidence of moderate-to-severe symptomatic intracranial hemorrhage within 72 hours Tidsramme: From randomization through 72 hours after randomization	Proportion of participants with symptomatic intracranial hemorrhage according to the modified Heidelberg criteria. The event must include imaging-confirmed intracranial hemorrhage, an increase of at least 4 points in the total NIHSS score compared with baseline or a previously recorded NIHSS score, and neurological deterioration that cannot be explained by a cause other than the intracranial hemorrhage. Qualifying hemorrhage types include parenchymal hematoma type 1 or 2, remote intracranial hemorrhage, subarachnoid hemorrhage, intraventricular hemorrhage, or subdural hemorrhage.	From randomization through 72 hours after randomization
All-cause mortality through Day 90 Tidsramme: From randomization through Day 90	Proportion of participants who die from any cause after randomization and through Day 90. Death will be recorded as an mRS score of 6.	From randomization through Day 90
Incidence of adverse events through Day 90 Tidsramme: From administration of the study intervention through Day 90 after randomization	Proportion of participants who experience at least one adverse event after administration of the study intervention. Adverse events will be recorded with respect to onset, duration, severity, relationship to the study intervention, action taken, and outcome, and will be coded using the Medical Dictionary for Regulatory Activities.	From administration of the study intervention through Day 90 after randomization
Incidence of serious adverse events through Day 90 Tidsramme: From administration of the study intervention through Day 90 after randomization	Proportion of participants who experience at least one serious adverse event. A serious adverse event is an event that results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability, causes a congenital anomaly or birth defect, or is considered an important medical event requiring intervention to prevent a serious outcome.	From administration of the study intervention through Day 90 after randomization

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Peking Union Medical College Hospital

Samarbejdspartnere

Chinese PLA General Hospital

Huashan Hospital

Hebei General Hospital

The Affiliated Hospital of Qingdao University

Nanjing First Hospital, Nanjing Medical University

The First Affiliated Hospital of Zhengzhou University

Zhongnan Hospital

First Affiliated Hospital of Harbin Medical University

Taihe Hospital

Liaocheng People's Hospital

Weifang People's Hospital

Baotou Central Hospital

Chongqing General Hospital

Tangshan Worker's Hospital

Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine

Jining First People's Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

31. december 2028

Studieafslutning (Anslået)

31. december 2029

Datoer for studieregistrering

Først indsendt

7. marts 2026

Først indsendt, der opfyldte QC-kriterier

11. marts 2026

Først opslået (Faktiske)

12. marts 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. juli 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

1-24PJ2600
2024ZD0521605 (Andet bevillings-/finansieringsnummer: the Noncommunicable Chronic Diseases-National Science and Technology Major Project)
82025013 (Andet bevillings-/finansieringsnummer: the National Science Fund for Distinguished Young Scholars)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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PCSK9-hæmmer til intrakraniel aterosklerose-relateret akut iskæmisk apopleksi (PISTIAS-3)