rhTNK-tPA for Acute Ischemic Stroke Under Simplified Imaging in the Extended Time Window (SIMPLIFIED)
19. maj 2026 opdateret af: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
rhTNK-tPA for Acute Ischemic Stroke Under Simplified Imaging in the Extended Time Window: A Multicenter, Prospective, Randomized Controlled, Open-label, Blinded-Endpoint Trial
The PEARL-SIMPLIFIED trial is a multicenter, prospective, randomized controlled, open-label, blinded-endpoint study.
It aims to evaluate the efficacy and safety of intravenous tenecteplase (TNK) in patients with acute ischemic stroke (AIS) presenting in the extended 4.5-24 hour window, using a simplified imaging selection strategy based solely on non-contrast CT (NCCT).
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The PEARL-SIMPLIFIED trial is a multicenter, prospective, randomized controlled, open-label, blinded-endpoint study with a target enrollment of at least 750 patients.
The trial focuses on individuals with acute ischemic stroke (AIS) presenting within a 4.5 to 24-hour window who are not planned for endovascular thrombectomy (EVT).
Patients meeting simplified imaging criteria based on non-contrast CT (NCCT) are randomized 1:1 to receive a single intravenous bolus of 0.25 mg/kg tenecteplase (TNK) or standard medical treatment.
The primary outcome is the 90-day excellent functional outcome, defined as a modified Rankin Scale (mRS) score of 0-1.
Safety outcomes include symptomatic intracranial hemorrhage (sICH) and 90-day mortality.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
750
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Jinyuan Wang
- Telefonnummer: 86-18558992193
- E-mail: wangjy257@mail2.sysu.edu.cn
Undersøgelse Kontakt Backup
- Navn: Xinguang Yang, MD, PhD
- E-mail: yangxinguang0926@163.com
Studiesteder
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-
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Guangzhou, Kina, 510120
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
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Kontakt:
- Jinyuan Wang
- Telefonnummer: 86-20-81332619
- E-mail: wangjy257@mail2.sysu.edu.cn
-
Kontakt:
- Xinguang Yang, MD, PhD
- E-mail: yangxinguang0926@163.com
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Ledende efterforsker:
- Yamei Tang, MD, PhD
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-
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
Inclusion Criteria:
- Age 18 years or older.
- Presumed acute ischemic stroke of the anterior circulation.
- Acute ischemic stroke symptom onset between 4.5 to 24 hours prior to enrollment; including wake-up stroke and unwitnessed stroke, onset time refers to 'last-known well time'.
- Baseline National Institutes of Health Stroke Scale (NIHSS) 6-25 (inclusive).
- Limited early ischemic changes on non-contrast CT (NCCT).
- Written informed consent signed by patients or their legally authorized representatives.
Exclusion Criteria:
- Clearly demarcated hypodensity on non-contrast CT related to the current stroke, with limited anticipated clinical benefit as judged by the investigator.
- Intracranial or subarachnoid hemorrhage identified on baseline NCCT.
- Endovascular thrombectomy (EVT) planned at the time of randomization.
- Pre-stroke mRS≥2.
- Allergy to the test drug and its ingredients.
- Severe head trauma or ischemic stroke in the last 3 months.
- Intracranial or intraspinal surgery within 3 months before enrollment.
- Intracranial tumor or large-size aneurysm found before enrollment.
- Gastrointestinal or urinary system hemorrhage within the past 3 weeks.
- Active visceral bleeding.
- Aortic arch dissection confirmed by examination or medical history.
- Infective endocarditis confirmed by examination or medical history.
- Platelet count less than 100 × 109 /L.
- Patients received heparin or low-molecular-weighted heparin treatment within 24h before enrollment.
- Pregnant or lactating women.
- Blood glucose <50 mg/dl (2.78mmol/L) or >400 mg/dl (22.2mmol/L) during screening.
- Uncontrolled hypertension with persistent systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg, refractory to medical management.
- Life expectancy less than 6 months due to malignancy, severe cardiopulmonary disease, or other terminal illness.
- Participating in other trials.
- Other conditions deemed unsuitable for the study by the investigator, such as inability to comprehend or comply with study procedures or follow-up due to mental illness, cognitive or emotional disorder.
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: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Intervention Arm
Intravenous tenecteplase
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Patients randomized to the intervention arm will receive tenecteplase via a single intravenous bolus (0.25 mg/kg; maximum dose 25 mg), administered immediately following randomization.
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Aktiv komparator: Control Arm
Standard medical treatment
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Patients in the control arm will receive standard medical treatment.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Excellent functional outcome
Tidsramme: at 90 (±14) days
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The proportion of mRS score 0-1 at 90 (±14) days.
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at 90 (±14) days
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Ordinal distribution of mRS
Tidsramme: at 90 (±14) days
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The proportion of mRS distribution at 90 (±14) days
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at 90 (±14) days
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Favorable functional outcome
Tidsramme: at 90 (±14) days
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The proportion of mRS score 0-2 at 90 (±14) days
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at 90 (±14) days
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Change in NIHSS Score at 24 (±12) hours
Tidsramme: at 24 (±12) hours
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NIHSS score change from baseline at 24 (±12) hours
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at 24 (±12) hours
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Change in NIHSS Score at 7 (±1) days or discharge
Tidsramme: at 7 (±1) days or discharge
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NIHSS score change from baseline at 7 (±1) days or discharge
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at 7 (±1) days or discharge
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Quality of life (EQ-5D-5L)
Tidsramme: at 90 (±14) days
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Quality of life measured by EQ-5D-5L at 90 (±14) days
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at 90 (±14) days
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Symptomatic intracranial hemorrhage
Tidsramme: within 36 hours
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Symptomatic intracranial hemorrhage (sICH) within 36 hours from randomization (SITS-MOST criteria)
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within 36 hours
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Any intracranial hemorrhage
Tidsramme: within 36 hours
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Any intracranial hemorrhage within 36 hours
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within 36 hours
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Major extracranial bleeding
Tidsramme: within 36 hours
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Major extracranial bleeding within 36 hours (GUSTO criteria: moderate and severe bleeding)
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within 36 hours
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Mortality
Tidsramme: within 90 days
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All-cause mortality within 90 days
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within 90 days
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Yamei Tang, MD, PhD, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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. august 2026
Primær færdiggørelse (Anslået)
1. december 2028
Studieafslutning (Anslået)
1. december 2028
Datoer for studieregistrering
Først indsendt
22. april 2026
Først indsendt, der opfyldte QC-kriterier
19. maj 2026
Først opslået (Faktiske)
26. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
26. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. maj 2026
Sidst verificeret
1. april 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Cerebrovaskulære lidelser
- Hjernesygdomme
- Sygdomme i centralnervesystemet
- Sygdomme i nervesystemet
- Karsygdomme
- Hjerte-kar-sygdomme
- Slag
- Iskæmisk slagtilfælde
- Aminosyrer, peptider og proteiner
- Proteiner
- Hydrolaser
- Enzymer
- Enzymer og coenzymer
- Blodproteiner
- Endopeptidaser
- Peptidhydrolaser
- Serinendopeptidaser
- Serinproteaser
- Plasminogenaktivatorer
- Blodkoagulationsfaktorer
- Vævsplasminogenaktivator
- Tenecteplase
Andre undersøgelses-id-numre
- PEARL-SIMPLIFIED
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
The IPD will be available from the Principal Investigator upon reasonable request 6 months after the trial completion.
IPD-delingstidsramme
6 months after the trial completion.
IPD-delingsadgangskriterier
The IPD will be available from the Principal Investigator upon reasonable request 6 months after the trial completion.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
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