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Reperfusion Approach in Predicted In-hospital Delay for Primary PCI in STEMI (RAPID-STEMI)

8. juni 2026 opdateret af: Dmitry Pevzner, National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

A Randomized Controlled Study of Reperfusion Strategies in Acute ST-segment Elevation Myocardial Infarction Under Conditions of Anticipated In-hospital Delay in Primary Percutaneous Coronary Intervention Strategy: the Reperfusion Approach in Predicted In-hospital Delay for Primary PCI in STEMI (RAPID-STEMI)

This study aims at evaluating of the effectiveness of in-hospital thrombolysis for ST-segment elevation myocardial infarction in PCI centers under conditions of predicted in-hospital delay (>60 min after admission in PCI-center) of PCI. Following randomisation a strategy of early tenecteplase and additional antiplatelet and antithrombin therapy followed by catheterisation within 2-24 hours with timely coronary intervention as appropriate (or by rescue coronary intervention if required) in Group A will be compared to primary PCI performed according to local standards in Group B.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

240

Fase

  • Fase 4

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Rusland
    • Select A State
      • Moscow, Select A State, Rusland, 121552
        • National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
        • 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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Age equal or greater than 18 years
  • "Symptom onset-randomization" time interval <12 hours
  • Predicted "diagnosis-pPCI" time interval equal or greater than 120 minutes
  • Predicted "admission-pPCI" time interval equal or greater than 60 minutes
  • Informed consent received

Exclusion Criteria:

  • Medical history, procedures, medication administration or the presence of factors that would in general predispose to bleeding events and/or the inability to evaluate the study primary endpoint

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: In-hospital thrombolysis in PCI-center
In-hospital thrombolysis with tenecteplase in case of predicted delayed pPCI (>60 min after admission in PCI-center). Early tenecteplase, clopidogrel and enoxaparin followed by routine or rescue coronary intervention.
Medicin: Single, weight-adjusted i.v. bolus of tenecteplase
Single, weight-adjusted i.v. bolus of tenecteplase in case of >60 min in-hospital delay in PCI center
Procedure: catheterisation
Standard primary PCI
Andre navne:
  • Routine or rescue coronary intervention
Aktiv komparator: Primary PCI in PCI-center
Standard primary PCI in case of predicted delayed pPCI (>60 min after admission in PCI-center).
Procedure: catheterisation
Standard primary PCI
Andre navne:
  • Routine or rescue coronary intervention

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The number of observed patients with cardiovascular death, nonfatal stroke, and nonfatal AMI within 12 months for FAS.
Tidsramme: From enrollment to the end of follow-up (12 months).
Participants achieved a response if they have cardiovascular death or nonfatal stroke, or nonfatal AMI at 12 months.
From enrollment to the end of follow-up (12 months).

Sekundære resultatmål

Resultatmål
Tidsramme
Number of patients with all-cause mortality
Tidsramme: during hospitalization (assessed up to 10 days)
during hospitalization (assessed up to 10 days)
Number of patients with cardiovascular mortality
Tidsramme: during hospitalization (assessed up to 10 days)
during hospitalization (assessed up to 10 days)
Number of patients with non-fatal MI
Tidsramme: during hospitalization (assessed up to 10 days)
during hospitalization (assessed up to 10 days)
Number of patients with hemorrhagic stroke
Tidsramme: during hospitalization (assessed up to 10 days)
during hospitalization (assessed up to 10 days)
Number of patients with major bleeding according to the BARC scale (type 3-5)
Tidsramme: during hospitalization (assessed up to 10 days)
during hospitalization (assessed up to 10 days)
Number of patients with non-fatal complications of MI (AHF, cardiogenic shock, arrhythmias, MI, mechanical complications, thromboembolic complications )
Tidsramme: during hospitalization (assessed up to 10 days)
during hospitalization (assessed up to 10 days)
Number of patients with all-cause mortality
Tidsramme: 12 months
12 months
Number of patients with cardiovascular mortality
Tidsramme: 12 months
12 months
Number of patients with non-fatal MI
Tidsramme: 12 months
12 months
Number of patients with hemorrhagic stroke
Tidsramme: 12 months
12 months
Number of patients with major bleeding according to the BARC scale (type 3-5)
Tidsramme: 12 months
12 months
Number of patients with non-fatal complications of MI (AHF, cardiogenic shock, arrhythmias, MI, mechanical complications, thromboembolic complications)
Tidsramme: 12 months
12 months

Samarbejdspartnere og efterforskere

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

Sponsor

National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

Samarbejdspartnere

AO GENERIUM

Efterforskere

  • Studieleder: Dmitry Pevzner, Doctor of Medical Sciences, National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
  • Ledende efterforsker: Rimma Gulyan, National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

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)

20. maj 2026

Primær færdiggørelse (Anslået)

20. maj 2028

Studieafslutning (Anslået)

20. maj 2029

Datoer for studieregistrering

Først indsendt

2. juni 2026

Først indsendt, der opfyldte QC-kriterier

8. juni 2026

Først opslået (Faktiske)

11. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 324-2026-04-27

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