PCSK9-hemmer for intrakraniell aterosklerose-relatert akutt iskemisk slag (PISTIAS-3)
14. juli 2026 oppdatert av: Wei-Hai Xu, Peking Union Medical College Hospital
PCSK9-hemmer for intrakraniell aterosklerose-relatert akutt iskemisk slag (PISTIAS-3): en randomisert, dobbeltblind, placebokontrollert studie
Denne studien er et prospektivt, multicenter, dobbeltblind, randomisert, placebokontrollert klinisk forsøk som er designet for å evaluere om tidlig administrering av PCSK9-hemmere effektivt kan forbedre funksjonelle utfall etter 90 dager hos pasienter med iskemisk slag (AIS) assosiert med intrakraniell aterosklerotisk stenose (ICAS), primært vurdert ved bruk av modifisert Rankin-skala etter 90 dager.
Studieoversikt
Status
Har ikke rekruttert ennå
Detaljert beskrivelse
Akutt iskemisk slag (AIS) forblir en av de ledende årsakene til død og funksjonshemming på verdensbasis.
Selv om intravenøs trombolyse og endovaskulær terapi har betydelig forbedret reperfusionssuksessratene, vedvarer tre kritiske utfordringer i klinisk praksis som avgjør prognosen: For det første kan kun en begrenset andel av pasientene faktisk motta reperfusjonsterapi innenfor det terapeutiske tidsvinduet; For det andre kan selv med vellykket reperfusjon, sekundære skader som mikrosirkulatorisk perfusjonssvikt, inflammatoriske kaskader og trombusreformasjon fortsatt oppstå.
For det tredje forblir akuttfasefluktuasjoner, spesielt tidlig nevrologisk forverring og risikoen for tidlig tilbakefall, fremtredende, noe som direkte begrenser forbedringer i funksjonelle utfall.
3 Intrakraniell aterosklerotisk stenose (ICAS) utgjør opptil 50% av iskemisk slag etiologier i Kina.
Dens patologiske kjede-"plakkustabilitet-tromboze-mikrosirkulatorisk skade"-gjennomsyrer både den akutte og subakute fasen, og korrelerer nært med tidlig tilbakefall og dårlige utfall.Proprotein convertase subtilisin/kexin type 9 (PCSK9) fremmer klassisk nedbrytningen av lavdensitetslipoprotein kolesterol (LDL-C) reseptorer og øker LDL-C-nivåer, og driver dermed ateroskleroseprogresjonen.
Viktigere, økende grunnleggende og translasjonsforskning tyder på at PCSK9 kanskje ikke bare fungerer som et "lipide metabolisme protein" men også deltar i prosesser som endotellaktivering, inflammatoriske kaskader, trombocytreaktivitet og mikrosirkulatorisk dysfunksjon.
Dette posisjonerer det som et potensielt knutepunkt som forbinder "plakk-trombus-inflammasjon"-aksen.
Følgelig kan PCSK9-hemmere tilby ytterligere nevrovaskulære beskyttelsesfordeler utover lipidsenkende effekter under den akutte fasen av akutt iskemisk slag (AIS).Eksisterende grunnleggende og klinisk evidens tyder på at PCSK9-hemmere kan utøve en kombinert intervensjonseffekt på nøkkelpatologiske prosesser som driver aterosklerose under den akutte fasen av AIS gjennom en dual mekanisme som involverer både lipidavhengige og ikke-lipidavhengige baner.
Mekanistiske studier avslører at PCSK9-hemming samtidig modulerer inflammatoriske responser, endotellaktivering, dysfunksjon og trombogene tendenser.
I iskemi-reperfusionsmodeller demonstrerer det nevrobeskyttende signalering ved å dempe hjerneskade og forbedre nevrologisk funksjon.
Klinisk bekrefter store randomiserte forsøk dens evne til raskt å forbedre lipidsenkende effekter utover statiner og redusere risikoen for iskemisk slag.
Ytterligere translasjonsevidens i cerebrovaskulær sykdom indikerer at i symptomatiske ICAS-populasjoner, reduserer PCSK9-hemmer pluss statin-forbedret lipidsenkende terapi plakkbyrde, lindrer stenose og øker plakkstabilitet.
I den akutte fasen av AIS korrelerer tidlig tilsetting av PCSK9-hemmere med redusert nevrologisk forverring innen 7 dager, redusert tilbakefallsrisiko innen 30 dager og forbedrede funksjonelle utfall etter 90 dager.
Samlet sett gir denne evidenskjeden som strekker seg fra mekanismer til klinisk praksis klar vitenskapelig rasjonalitet og klinisk nødvendighet for å tilsette PCSK9-hemmere i behandlingen av ICAS-assosiert AIS.Denne studien er et landsdekkende, prospektivt, multikenter, dobbeltblind, randomisert, placebokontrollert klinisk forsøk.
Den vil inkludere 1 212 pasienter som oppfyller inklusjons- og eksklusjonskriterier.
Pasienter vil bli tilfeldig tildelt to grupper ved bruk av en randomisert tildelingsmetode: (1) Eksperimentell gruppe: 450 mg av Recaticimab for injeksjon (3 flasker) administrert som en enkelt subkutan injeksjon.
(2) Kontrollgruppe: Placebo av Recaticimab for injeksjon 450 mg (3 flasker) administrert som en enkelt subkutan injeksjon.
Hver gruppe vil inkludere 606 pasienter.
Begge grupper vil motta standard retningslinjeanbefalt behandling i tillegg til studiemedikamentet.
Langtidseffekt ble vurdert gjennom pasientbesøk og evalueringer ved 0 timer, 24 timer (±2 eller ±12 timer), 7 dager (±2 dager) eller ved utskrivelse, 90 dager (±7 dager), og 1 år.Primære utfallsmål inkluderte: Analyse basert på intensjon-til-behandling-prinsippet ved bruk av en ANCOVA-modell for alle randomiserte pasienter med baseline HRMRI og en modifisert Rankin Scale (mRS) score på 0-2 etter 90 dager.
Sekundære utfallsmål inkluderte: (1) mRS score på 0-1 etter 90 dager (indikerer god pasientfunksjon); (2) Distribusjon av 90-dagers mRS-scorer; (3) Ethvert slag (inkludert iskemisk og hemorragisk) innen 90 dager; (4) Iskemisk slag innen 90 dager; (5) Sammensatte vaskulære hendelser (inkludert slag, hjerteinfarkt og vaskulær død) innen 90 dager; (6) 90-dagers European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) score; (7) 90-dagers Barthel Index (BI) score.Detaljer er gitt i "Utfallsmål"-delen.Styrken beregnes basert på det primære utfallet og totalt 1212 deltakere forventes.
Et uavhengig Data Safety Monitoring Board vil overvåke den generelle gjennomføringen av forsøket.
Studietype
Intervensjonell
Registrering (Antatt)
1212
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Yiyang Liu, PhD
- Telefonnummer: 86+13938912070
- E-post: liuyydoct@163.com
Studer Kontakt Backup
- Navn: Weihai Xu, MD
- Telefonnummer: 86+13938912070
- E-post: xuwh@pumch.cn
Studiesteder
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Beijing, Kina
- Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, Beijing 100730
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Ta kontakt med:
- Weihai Xu, MD
- Telefonnummer: 86+13651147766
- E-post: xuwh@pumch.cn
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Hovedetterforsker:
- Weihai Xu, MD
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Chongqing, Kina
- Chongqing General Hospital
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Shanghai, Kina
- Huashan Hospital, Fudan University
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100853
- Chinese PLA General Hospital
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Ta kontakt med:
- Shiwen Wu, MD
- Telefonnummer: 86+13910238117
- E-post: wu_shiwen@outlook.com
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Hovedetterforsker:
- Shiwen Wu, MD
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Guangdong
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Meizhou, Guangdong, Kina
- The Third Affiliated Hospital of Sun Yat-sen University, Yuedong Hospital
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Hebei
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Cangzhou, Hebei, Kina
- Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
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Qinhuangdao, Hebei, Kina
- Peking University Third Hospital Qinhuangdao Hospital
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Shijiazhuang, Hebei, Kina, 050051
- Hebei Provincial People's Hospital
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Tangshan, Hebei, Kina, 063000
- Tangshan Worker's Hospital
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Ta kontakt med:
- Baoquan Lu
- Telefonnummer: 13930565557
- E-post: balcom@163.com
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Hovedetterforsker:
- Baoquan Lu, MD
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Heilongjiang
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Harbin, Heilongjiang, Kina
- First Affiliated Hospital of Harbin Medical University
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Henan
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Zhengzhou, Henan, Kina
- The First Affiliated Hospital of Zhengzhou University
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Hubei
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Shiyan, Hubei, Kina
- Affiliated Taihe Hospital of Hubei University of Medicine
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Wuhan, Hubei, Kina
- Zhongnan Hospital of Wuhan University
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Inner Mongolia
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Baotou, Inner Mongolia, Kina, 014000
- Baotou Central Hospital
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Jiangsu
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Nanjing, Jiangsu, Kina, 210000
- Nanjing First Hospital
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Shandong
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Jining, Shandong, Kina, 272000
- Jining First People's Hospital
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Liaocheng, Shandong, Kina, 252000
- Liaocheng People's Hospital
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Qingdao, Shandong, Kina
- The Affiliated Hospital of Qingdao University
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Weifang, Shandong, Kina, 261000
- Weifang People's Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inklusjonskriterier:
- Alder >=30 og <=80
- Akutt iskemisk slag innen 72 timer fra debut (fastslått ved CT/MRI i kombinasjon med nevrologiske deficitsymptomer)
- NIHSS-score på 4-25 ved innleggelse
- Bildediagnostikk (CTA/DSA/MRA) støtter intrakraniell aterosklerose som årsak til slaget, og oppfyller ett av følgende kriterier: i. Den skyldige blodåren viser intrakraniell aterosklerotisk stenose (ICAS) med en innsnevring på 50-99%; ii. Den skyldige blodåren viser intrakraniell aterosklerotisk okklusjon (ICAS-LVO), med vellykket rekanalisering oppnådd via mekanisk trombektomi (umiddelbar utvidet trombolyse i cerebral infarkt [eTICI] grad 2b50-3)
- Informerert samtykke signert
Eksklusjonskriterier:
- Ikke-aterosklerotisk intrakraniell arteriell stenose (som arteriedisseksjon, Moyamoya-sykdom, systemisk vaskulitt, etc.)
- Enhver identifiserbar kilde til kardiogen emboli (som atrieflimmer, mekaniske klaffer, venstre ventrikkel trombus, åpent foramen ovale, etc.)
- Bildefunn og klinisk presentasjon tyder på at den primære patofysiologien for denne hendelsen er mer i samsvar med cerebral smååressykdom (f.eks. perforatorarterieokklusjon/lakunær infarkt)
- Eksisterende funksjonshemming før denne iskemiske hendelsen (modifisert Rankin-skala ≥ 2 poeng)
- CT- eller MRI-funn tyder på omfattende cerebral infarkt (f.eks. ASPECTS-score < 6 eller infarktvolum ≥ 70 ml)
- Har gjennomgått eller er planlagt for en vaskulær stentimplantasjonsprosedyre innen de neste tre månedene
- Enhver intrakraniell blødning som har oppstått innen 3 måneder før inkludering
- Intrakranielle svulster, cerebralaneurismer eller arteriovenøse misdannelser som vurderes å ha indikasjoner for intervensjonsbehandling
- Alvorlig aktiv blødningstendens eller koagulasjonsforstyrrelse
- Alvorlig dysfunksjon av vitale organer som hjerte, lever og nyrer
- Mottatt PCSK9 monoklonalt antistoff-hemmerbehandling innen 1 måned før inkludering eller PCSK9 siRNA-hemmerbehandling innen 6 måneder før inkludering
- En klar kontraindikasjon mot statiner eller en historie med intoleranse mot dem
- Graviditet, amming eller planlegging av graviditet
- Deltar for tiden i en annen studie
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Recaticimab pluss standard terapi-gruppe
Recaticimab i kombinasjon med standardbehandling
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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.
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Placebo komparator: Recaticimab's placebo in combination with standard therapy group
Recaticimab's placebo in combination with standard therapy
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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."
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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
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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.
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Day 90 (±7 days) after randomization
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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
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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.
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Day 90 (±7 days) after randomization
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Distribution of modified Rankin Scale (mRS) scores at Day 90
Tidsramme: Day 90 (±7 days) after randomization
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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.
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Day 90 (±7 days) after randomization
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Incidence of any stroke through Day 90
Tidsramme: From randomization through Day 90
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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.
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From randomization through Day 90
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Incidence of ischemic stroke through Day 90
Tidsramme: From randomization through Day 90
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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.
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From randomization through Day 90
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Incidence of composite vascular events through Day 90
Tidsramme: From randomization through Day 90
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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.
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From randomization through Day 90
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Barthel Index score at Day 90
Tidsramme: Day 90 (±7 days) after randomization
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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.
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Day 90 (±7 days) after randomization
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Health-related quality of life assessed using the EQ-5D-5L at Day 90
Tidsramme: Day 90 (±7 days) after randomization
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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).
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Day 90 (±7 days) after randomization
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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
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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.
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Day 7 (±2 days) after randomization or at hospital discharge, whichever occurs first
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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
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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.
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From baseline to Day 7 (±2 days) after randomization or hospital discharge, whichever occurs first
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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
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Proportion of participants whose measured low-density lipoprotein cholesterol (LDL-C) concentration is below 1.4 mmol/L at the scheduled assessment.
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Day 7 (±2 days) after randomization or at hospital discharge, whichever occurs first
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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
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Proportion of participants whose measured low-density lipoprotein cholesterol (LDL-C) concentration is below 1.8 mmol/L at the scheduled assessment.
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Day 7 (±2 days) after randomization or at hospital discharge, whichever occurs first
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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
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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.
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From baseline to Day 7 (±2 days) after randomization or hospital discharge, whichever occurs first
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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
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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.
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From baseline to 24 hours after randomization, with an allowable assessment window of -2 to +12 hours
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Cerebral infarct volume at Day 7 or hospital discharge
Tidsramme: Day 7 (±2 days) after randomization or at hospital discharge, whichever occurs first
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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.
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Day 7 (±2 days) after randomization or at hospital discharge, whichever occurs first
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Cerebral perfusion parameters at Day 7 or hospital discharge
Tidsramme: Day 7 (±2 days) after randomization or at hospital discharge, whichever occurs first
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Prespecified quantitative cerebral perfusion parameters derived from CT perfusion or MR perfusion imaging will be assessed by a blinded core imaging laboratory.
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Day 7 (±2 days) after randomization or at hospital discharge, whichever occurs first
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Serum interleukin-6 concentration at Day 7 or hospital discharge
Tidsramme: Day 7 (±2 days) after randomization or at hospital discharge, whichever occurs first
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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.
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Day 7 (±2 days) after randomization or at hospital discharge, whichever occurs first
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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
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High-sensitivity C-reactive protein concentration will be measured as a marker of systemic inflammation.
Higher concentrations indicate greater inflammatory activity.
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Day 7 (±2 days) after randomization or at hospital discharge, whichever occurs first
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Incidence of any stroke through 1 year
Tidsramme: From randomization through 1 year
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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.
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From randomization through 1 year
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Incidence of ischemic stroke through 1 year
Tidsramme: From randomization through 1 year
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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.
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From randomization through 1 year
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Incidence of composite vascular events through 1 year
Tidsramme: From randomization through 1 year
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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.
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From randomization through 1 year
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Health-related quality of life assessed using the EQ-5D-5L at 1 year
Tidsramme: At 1 year after randomization
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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.
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At 1 year after randomization
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Barthel Index score at 1 year
Tidsramme: At 1 year after randomization
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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.
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At 1 year after randomization
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Incidence of moderate-to-severe symptomatic intracranial hemorrhage within 72 hours
Tidsramme: From randomization through 72 hours after randomization
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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.
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From randomization through 72 hours after randomization
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All-cause mortality through Day 90
Tidsramme: From randomization through Day 90
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Proportion of participants who die from any cause after randomization and through Day 90.
Death will be recorded as an mRS score of 6.
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From randomization through Day 90
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Incidence of adverse events through Day 90
Tidsramme: From administration of the study intervention through Day 90 after randomization
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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.
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From administration of the study intervention through Day 90 after randomization
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Incidence of serious adverse events through Day 90
Tidsramme: From administration of the study intervention through Day 90 after randomization
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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.
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From administration of the study intervention through Day 90 after randomization
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Sabatine MS, Giugliano RP, Keech AC, Honarpour N, Wiviott SD, Murphy SA, Kuder JF, Wang H, Liu T, Wasserman SM, Sever PS, Pedersen TR; FOURIER Steering Committee and Investigators. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. N Engl J Med. 2017 May 4;376(18):1713-1722. doi: 10.1056/NEJMoa1615664. Epub 2017 Mar 17.
- Liu L, Chen W, Zhou H, Duan W, Li S, Huo X, Xu W, Huang L, Zheng H, Liu J, Liu H, Wei Y, Xu J, Wang Y; Chinese Stroke Association Stroke Council Guideline Writing Committee. Chinese Stroke Association guidelines for clinical management of cerebrovascular disorders: executive summary and 2019 update of clinical management of ischaemic cerebrovascular diseases. Stroke Vasc Neurol. 2020 Jun;5(2):159-176. doi: 10.1136/svn-2020-000378. Epub 2020 Jun 18.
- Gutierrez J, Turan TN, Hoh BL, Chimowitz MI. Intracranial atherosclerotic stenosis: risk factors, diagnosis, and treatment. Lancet Neurol. 2022 Apr;21(4):355-368. doi: 10.1016/S1474-4422(21)00376-8. Epub 2022 Feb 7.
- Zhao W, Li S, Li C, Wu C, Wang J, Xing L, Wan Y, Qin J, Xu Y, Wang R, Wen C, Wang A, Liu L, Wang J, Song H, Feng W, Ma Q, Ji X; TREND Investigators. Effects of Tirofiban on Neurological Deterioration in Patients With Acute Ischemic Stroke: A Randomized Clinical Trial. JAMA Neurol. 2024 Jun 1;81(6):594-602. doi: 10.1001/jamaneurol.2024.0868.
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- Prabhakaran S, Gonzalez NR, Zachrison KS, Adeoye O, Alexandrov AW, Ansari SA, Chapman S, Czap AL, Dumitrascu OM, Ishida K, Jadhav AP, Johnson B, Johnston KC, Khatri P, Kimberly WT, Lee VH, Leslie-Mazwi TM, Mac Grory B, Madsen TE, Menon B, Mistry EA, Park S, Parker S, Perez de la Ossa N, Reeves M, Saiz T, Scott PA, Schwartzberg D, Sheth SA, Sporns PB, Times S, Tjoumakaris S, Wolfe SQ, Yaghi S; Peer Review Committee. 2026 Guideline for the Early Management of Patients With Acute Ischemic Stroke: A Guideline From the American Heart Association/American Stroke Association. Stroke. 2026 Jan 26. doi: 10.1161/STR.0000000000000513. Online ahead of print.
- Sun Y, Lv Q, Guo Y, Wang Z, Huang R, Gao X, Han Y, Yao Z, Zheng M, Luo S, Li Y, Gu X, Zhang Y, Wang J, Hong L, Ma X, Su G, Sheng J, Lai C, Shen A, Wang M, Zhang W, Wu S, Zheng Z, Li J, Zhong T, Wang Y, He L, Du X, Ma CS. Recaticimab as Add-On Therapy to Statins for Nonfamilial Hypercholesterolemia: The Randomized, Phase 3 REMAIN-2 Trial. J Am Coll Cardiol. 2024 Nov 12;84(20):2037-2047. doi: 10.1016/j.jacc.2024.09.012.
- Xu M, Wang Z, Zhang Y, Liu Y, Huang R, Han X, Yao Z, Sun J, Tian F, Hu X, Ma L, Lai C, Zhang X, Sheng J, Han Q, Jin C, Luo L, Zhao R, Li L, Xu B, Yin D, Luo S, Ge X, Liu Z, Yang P, Huang Z, Li T, Feng W, Wu Y, Ling Z, Ma L, Lv C, Deng C, Wei W, Wang Y, Yan L, Ge J; REMAIN-1 Investigators. Recaticimab Monotherapy for Nonfamilial Hypercholesterolemia and Mixed Hyperlipemia: The Phase 3 REMAIN-1 Randomized Trial. J Am Coll Cardiol. 2024 Nov 12;84(20):2026-2036. doi: 10.1016/j.jacc.2024.07.035. Epub 2024 Oct 9.
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. september 2026
Primær fullføring (Antatt)
31. desember 2028
Studiet fullført (Antatt)
31. desember 2029
Datoer for studieregistrering
Først innsendt
7. mars 2026
Først innsendt som oppfylte QC-kriteriene
11. mars 2026
Først lagt ut (Faktiske)
12. mars 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
15. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. juli 2026
Sist bekreftet
1. april 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Cerebrovaskulære lidelser
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i nervesystemet
- Vaskulære sykdommer
- Kardiovaskulære sykdommer
- Patologiske tilstander, anatomiske
- Arteriosklerose
- Arterielle okklusive sykdommer
- Intrakranielle arterielle sykdommer
- Patologiske tilstander, tegn og symptomer
- Plakk, aterosklerotisk
- Intrakraniell arteriosklerose
- Health Services Administration
- Helsevesenets kvalitet, tilgang og evaluering
- Kvalitet på helsehjelpen
- Kvalitetsindikatorer, helsehjelp
- Standard for omsorg
Andre studie-ID-numre
- 1-24PJ2600
- 2024ZD0521605 (Annet stipend/finansieringsnummer: the Noncommunicable Chronic Diseases-National Science and Technology Major Project)
- 82025013 (Annet stipend/finansieringsnummer: the National Science Fund for Distinguished Young Scholars)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .