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Multicentre 2x2 Factorial Randomised Study Comparing Tirofiban Versus Abciximab and SES Versus BMS in AMI

26. oktober 2011 opdateret af: Marco Valgimigli

Multicentre 2x2 Factorial Randomised Study Comparing Tirofiban Administered With the Single High-Dose Bolus Versus Abciximab and Sirolimus Eluting Stent Versus Bare Metal Stent in Acute Myocardial Infarction - MULTI-STRATEGY Trial

The purpose of this study is to determine which from the four combinations tirofiban+sirolimus eluting stent (SES), tirofiban+bare metal stent (BMS), abciximab+SES, abciximab+BMS is the possible gold standard treatment for ST-segment elevation myocardial infarction in terms of efficacy and cost-efficacy.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The combination abciximab plus bare metal stent (BMS) is currently considered the standard therapy for AMI. The use of sirolimus eluting stent (SES) is related to a reduction of the need for urgent target vessel revascularization (TVR). With current acquisition prices for abciximab and SES, replacing abciximab with tirofiban, administered as a single high-dose bolus (SHDB) regimen, is a promising strategy that would preserve financial resources. In a recent study the combination tirofiban and SES resulted to be associated to an overall lower major adverse cardiovascular events (MACE) rate with respect to the abciximab plus BMS. However, since no conclusion can be drawn yet regarding the relative contribution of a specific GP IIb/IIIa inhibitor or a stent type with respect to the other, the combination of abciximab and SES may be associated to an even lower event rate with respect to SHDB tirofiban and SES, thus offsetting the higher initial cost.

Comparison(s): four strategies (SHDB tirofiban + BMS, SHDB tirofiban + SES, abciximab + BMS, abciximab + SES) are compared to determine the possible gold standard treatment for ST-segment elevation myocardial infarction in terms of efficacy and cost-efficacy.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

744

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

  • Italien
      • Ferrara, Italien, 44100
        • Cattedra di Cardiologia, Azienda Ospedaliera Universitaria di Ferrara

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • ST segment elevation myocardial infarction
  • Schedule for primary percutaneous coronary intervention
  • Informed consent

Exclusion Criteria:

  • Administration of fibrinolytic or any GP IIb/IIIa inhibitors for the treatment of current acute myocardial infarction or within 1 month before it
  • History of bleeding diathesis or allergy to the studies drug
  • Major surgery within 30 days
  • Limited life expectancy, e.g. neoplasms, others
  • Pregnancy

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: Faktoriel opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 1
Patients will receive abciximab infusion at standard regimen prior undergoing percutaneous coronary intervention for STEMI followed by BMS implantation in the culprit lesion
Andet: abciximab followed by implantation of bare metal stent
Patients will receive infusion of abciximab at standard regimen before undergoing intervention for STEMI and then bare metal stent implantation in the culprit lesion
Andre navne:
  • Stent
  • Glycoprotein IIB/IIIa inhibitors
Eksperimentel: 2
Abciximab followed by implantation of sirolimus-eluting stent in the culprit lesion
Andet: abciximab and Sirolimus eluting stent
Patients will receive abciximab infusion at standard regimen followed by implantation of sirolimus-eluting stent in the culprit lesion
Andre navne:
  • DES
  • stent
  • lægemiddel-eluerende stent
  • glycoprotein IIb/IIIa inhibitors
Eksperimentel: 3
tirofiban infusion followed by bare metal stent implantation
Andet: tirofiban and bare metal stent
Patients will receive tirofiban infusion at high loading dose followed by standard infusion for 18-24 hours and subsequently they will be treated with bare metal stent implantation
Andre navne:
  • stent
  • glycoprotein IIb/IIIa inhibitors
  • uncoated stent
  • bare metal stent
Eksperimentel: 4
tirofiban and sirolimus-eluting stent
Andet: tirofiban and sirolimus-eluting stent
Patients will receive tirofiban infusion at high loading dose followed by standard infusion for 18-24 hours and subsequently they will be treated with sirolimus-eluting stent implantation
Andre navne:
  • DES
  • stent
  • SES
  • lægemiddel-eluerende stent
  • sirolimus-eluerende stent
  • glycoprotein IIb/IIIa inhibitors

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
The evaluation of the degree of ST-segment resolution after the mechanical intervention.
Tidsramme: 90 minutes after last balloon inflation
90 minutes after last balloon inflation
The cumulative rate of death for any cause, reinfarction and target vessel revascularisation
Tidsramme: 8 months
8 months

Sekundære resultatmål

Resultatmål
Tidsramme
Death, recurrent acute myocardial infarction, target vessel revascularization and target lesion revascularisation, considered separately or in combination.
Tidsramme: at any time during follow-up
at any time during follow-up
The evaluation of the cost-effectiveness of the involved experimental treatments.
Tidsramme: 8 months, 1,3 and 5 years
8 months, 1,3 and 5 years
stent thrombosis according to the ARC classification
Tidsramme: any time during follow-up
any time during follow-up
the degree of cumulative or single lead ST segment resolution at time frames different from the primary endpoint. the degree of residual ST segment elevation.
Tidsramme: immediately after intervention, at 90 minutes and at discharge
immediately after intervention, at 90 minutes and at discharge
bleeding rate defined according to different classifications including TIMI, Acuity, GUSTO and Steeple.
Tidsramme: at 30 days, 1 year, 3 and 5 years
at 30 days, 1 year, 3 and 5 years

Samarbejdspartnere og efterforskere

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

Sponsor

Marco Valgimigli

Efterforskere

  • Studiestol: Roberto Ferrari, Professor, Cattedra di Cardiologia, Azienda Ospedaliera Universitaria di Ferrara, Italy

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

1. november 2004

Primær færdiggørelse (Faktiske)

1. april 2007

Studieafslutning (Forventet)

1. marts 2012

Datoer for studieregistrering

Først indsendt

27. september 2005

Først indsendt, der opfyldte QC-kriterier

27. september 2005

Først opslået (Skøn)

29. september 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

27. oktober 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. oktober 2011

Sidst verificeret

1. oktober 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TSES-02-III

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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