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Trombeaspirationen under PCI efter trombolyse i STEMI (TAPSET)

3. september 2026 opdateret af: Shenghua Zhou

Trombeaspirationen under perkutan koronarintervention efter trombolyse ved myokardieinfarkt med ST-elevation

Målet med dette kliniske forsøg er at afgøre, om trombeaspiration kombineret med perkutan koronar intervention (PCI) forbedrer de kliniske resultater hos ST-segment elevation myokardieinfarkt (STEMI) patienter med høj trombebyrde efter trombolyse, sammenlignet med PCI alene. Undersøgelsespopulationen omfatter 3500 STEMI-patienter, bekræftet ved diagnose, som overføres til PCI-centre efter at have modtaget trombolyse og ikke har kontraindikationer for trombolyse. De vigtigste spørgsmål, som den sigter på at besvare er:

  1. Reducerer trombeaspiration 30-dages alvorlige kardiovaskulære hændelser (MACE), herunder kardiovaskulær død, tilbagevendende myokardieinfarkt, slagtilfælde eller genindlæggelse af hjertesvigt?
  2. Kan trombeaspiration forbedre mikrocirkulationen og de kliniske resultater for patienter med høj trombebelastning efter trombolyse? Forskere vil sammenligne patienter, der er tilfældigt tildelt til at modtage trombe-aspiration kombineret med PCI versus dem, der modtager PCI alene for at evaluere virkningerne på at reducere MACE og forbedre klinisk helbredelse.

Deltagerne vil:

Gennemgå indledende trombolyse efterfulgt af overførsel til PCI-centre. Bliv tilfældigt tildelt i et 1:1-forhold for at modtage enten trombe-aspiration kombineret med PCI eller PCI alene.

Følges i 30 dage efter behandling for at vurdere MACE og andre kliniske resultater.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

TAPSET is an investigator-initiated, prospective, multicenter, randomized, open-label, parallel-group superiority trial with blinded endpoint assessment. Consecutive patients with STEMI presenting within 24 hours of symptom onset undergo preliminary screening and provide written informed consent before randomization. Final eligibility is confirmed after diagnostic coronary angiography demonstrates TIMI thrombus grade 2 or higher in the culprit vessel before guidewire crossing or another intervention that could alter thrombus burden.

Eligible participants are randomized through a central web-based system, stratified by six coordinating-center networks, to manual aspiration with the Sniffer II thrombus aspiration catheter followed by PCI or PCI alone. Bailout aspiration with Sniffer II is permitted in the PCI-alone group when clinically necessary. Other thrombectomy devices are not permitted. Concomitant PCI techniques and pharmacological rescue treatment are determined by the operator according to contemporary care.

The primary endpoint is the first MACCE through day 30. Clinical events are independently adjudicated, and angiographic and electrocardiographic reperfusion outcomes are centrally assessed by reviewers blinded to treatment allocation. Follow-up occurs at 30 days, 6 months, and 12 months.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

3500

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Kina
    • Hunan
      • Changsha, Hunan, Kina, 410011
        • Rekruttering
        • Department of Cardiology, The Second Xiangya Hospital of Central South University
        • Kontakt:

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

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  1. Diagnosticeret med STEMI.
  2. Ingen kontraindikationer for trombolyse og har fået trombolytisk behandling.
  3. Gennemgår koronar angiografi inden for 2 til 24 timer efter trombolyse.
  4. Angiografiske resultater bekræfter TIMI trombebelastning ≥ 4 og reststenose > 50 %.

Ekskluderingskriterier:

  1. Kontraindikationer for trombolyse.
  2. Kardiogent shock.
  3. Behov for koronar bypass-transplantation.
  4. Alder under 18 år.
  5. Forventet levetid på mindre end 6 måneder.
  6. Kan ikke give informeret samtykke.

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
Eksperimentel: Manual Thrombus Aspiration + PCI
Participants undergo manual aspiration of angiographically evident thrombus in the culprit coronary artery using the Sniffer II thrombus aspiration catheter, followed by PCI.
Procedure: Manual thrombus aspiration
Manual aspiration is performed after guidewire passage and before balloon dilatation or stent implantation in the culprit coronary artery. A large-lumen aspiration catheter is connected to a syringe to generate negative pressure and remove visible thrombotic material. The operator selects the catheter configuration and determines the number of aspiration passes and when to discontinue aspiration according to coronary anatomy, residual thrombus, technical feasibility, and participant safety. Operators receive standardized device-specific training before participating in the trial. No other thrombectomy device is permitted.
Procedure: Percutaneous Coronary Intervention
PCI is performed according to contemporary guideline-directed care and local practice. Balloon dilatation, stent implantation, vascular access, antiplatelet treatment, procedural anticoagulation, intracoronary medication, and other procedural details are determined by the operator.
Aktiv komparator: PCI Alone
Participants undergo PCI without planned thrombus aspiration.
Procedure: Percutaneous Coronary Intervention
PCI is performed according to contemporary guideline-directed care and local practice. Balloon dilatation, stent implantation, vascular access, antiplatelet treatment, procedural anticoagulation, intracoronary medication, and other procedural details are determined by the operator.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Major Adverse Cardiac or Cerebrovascular Events (MACCE) Within 30 Days
Tidsramme: From randomization through 30 days
The proportion of participants experiencing at least one of the following events: all-cause death, recurrent myocardial infarction, stroke, rehospitalization for heart failure, or clinically indicated target-vessel revascularization. Each component will also be reported separately.
From randomization through 30 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Final TIMI Flow Grade 3
Tidsramme: At the end of the index PCI procedure
The proportion of participants with final Thrombolysis in Myocardial Infarction (TIMI) epicardial coronary flow grade 3, assessed by the blinded central angiographic assessment team.
At the end of the index PCI procedure
Myocardial Blush Grade 3
Tidsramme: At the end of the index PCI procedure
The proportion of participants with myocardial blush grade 3, assessed by the blinded central angiographic assessment team. The full myocardial blush grade 0-3 distribution will also be reported.
At the end of the index PCI procedure
Complete ST-Segment Resolution
Tidsramme: After PCI during the index hospitalization
The proportion of participants with at least 70% ST-segment resolution from the pre-PCI to the post-PCI electrocardiogram, assessed by the blinded central electrocardiographic assessment team.
After PCI during the index hospitalization
Any Stroke Through 30 Days
Tidsramme: From randomization through 30 days
The proportion of participants experiencing any adjudicated stroke.
From randomization through 30 days
Major Adverse Cardiac or Cerebrovascular Events Through 6 Months
Tidsramme: From randomization through 6 months
Time to the first occurrence of all-cause death, recurrent myocardial infarction, stroke, rehospitalization for heart failure, or clinically indicated target-vessel revascularization.
From randomization through 6 months
Major Adverse Cardiac or Cerebrovascular Events Through 12 Months
Tidsramme: From randomization through 12 months
Time to the first occurrence of all-cause death, recurrent myocardial infarction, stroke, rehospitalization for heart failure, or clinically indicated target-vessel revascularization.
From randomization through 12 months
Cardiovascular Death
Tidsramme: From randomization through 6 months and through 12 months
Time to death adjudicated as cardiovascular in cause, reported at both 6 months and 12 months after randomization.
From randomization through 6 months and through 12 months
All-Cause Death
Tidsramme: From randomization through 6 months and through 12 months
Time to death from any cause, reported at both 6 months and 12 months after randomization.
From randomization through 6 months and through 12 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Additional Adjudicated Safety Events
Tidsramme: From randomization through 12 months
The occurrence of transient ischemic attack, Bleeding Academic Research Consortium type 3 or 5 bleeding, and definite or probable stent thrombosis. Each event type will be reported separately.
From randomization through 12 months
Procedural and Device-Related Complications
Tidsramme: During the index PCI procedure and index hospitalization
The occurrence of coronary dissection or perforation; catheter entrapment, fracture, malfunction, or failure to retrieve; distal embolization; no-reflow; and access-site or other vascular complications. Each complication type will be reported separately.
During the index PCI procedure and index hospitalization

Samarbejdspartnere og efterforskere

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

Sponsor

Shenghua Zhou

Samarbejdspartnere

First Affiliated Hospital Xi'an Jiaotong University
Capital Medical University
Second Xiangya Hospital of Central South University
Second Hospital of Jilin University
The First Affiliated Hospital of Dalian Medical University
The General Hospital of Northern Theater Command

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 (Faktiske)

9. juli 2025

Primær færdiggørelse (Anslået)

30. juli 2028

Studieafslutning (Anslået)

30. juli 2029

Datoer for studieregistrering

Først indsendt

20. oktober 2024

Først indsendt, der opfyldte QC-kriterier

21. oktober 2024

Først opslået (Faktiske)

23. oktober 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KYZ20240204
  • 2023ZD0503705 (Andet bevillings-/finansieringsnummer: Development Center for Medical Science & Technology, National Health Commission of the People's Republic of China)

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IPD-delingstidsramme

Begyndende 3 måneder og slutter 3 år efter offentliggørelsen af ​​resultater

IPD-delingsadgangskriterier

For at få adgang til IPD og understøttende information skal interesserede parter kontakte den primære investigator eller udpegede undersøgelseskoordinator.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

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