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Assessment of Revascularization Versus Conservative Treatment in Heart Transplant Patients for a Clinical Event Reduction (ARCHER)

13. oktober 2015 opdateret af: Assistance Publique - Hôpitaux de Paris

Assessment of Revascularization Versus Conservative Treatment in Heart Transplant Patients for a Clinical Event Reduction: THE ARCHER TRIAL

The aim of the study is to compare optimal medical therapy alone versus percutaneous coronary intervention on top of medical therapy in the setting of heart transplant recipient coronary artery disease in a randomized trial.The primary endpoint assessed at 1 year is the composite of death, myocardial infarction, need for transitory or permanent ventricular assist device implantation, myocardial revascularization, occurrence or worsening of heart failure, any graft dysfunction and/or a decrease of left ventricular ejection fraction of at least 25% compared to baseline. The hypothesis of the study is the superiority of the interventional management over medical therapy alone in preventing the occurrence of the primary endpoint of the study.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The hypothesis of the study is the superiority of the interventional management over medical therapy alone in preventing the occurrence of the primary endpoint of the study assessed 1 year after randomization.

Objectives: To demonstrate the superiority of the interventional management on top of optimal medical therapy over optimal medical therapy alone in preventing the occurrence of the primary endpoint of the study assessed 1 year after randomization

Design : Multicenter, prospective randomized 1 :1, open-label blinded endpoint study

Target population : Heart transplant recipients, aged ≥18 years, without coronary artery disease-related symptoms, with angiographically significant coronary artery stenoses (≥50% anatomically adequate for a revascularization by coronary angioplasty with stent implantation, with no contraindication to dual antiplatelet therapy associating aspirin and a P2Y12 inhibitorfor a duration of 12 monthsand with ni grade IA ACC/AHA indication for revascularization

Inclusion period: 12 months (may be extended based on the inclusion rythme)

Maximum duration of participation for patients : 13 months

Total duration of the study : 37 months

Primary endpoint : The composit of death, myocardial infarction, retransplantation, implantation of transitory or definitve ventricular assist devices, new or worsening heart failure, graft failure and/or a decrease of left ventricular ejection fraction of at least 25% compared to baseline.The occurrence of any event qualifying for the primary endpoint will be assessed by a Cox survival analysis stratified on center.The primary endpoint will be assessed 12 months after randomization.

Secondary endpoints : Any of the individual events defining the primary outcome at 1 year

Number of patients to be included and power calculation : 80 patients per group. A 1 year primary endpoint rate of 30% in the active and 50% in with an inclusion period of 24 months and alpha=5% warants a 90% power using a cox model.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

6

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Frankrig
      • Paris, Frankrig, 75013
        • Pitié Salpetriere university Hospital - Cardiology

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:

  • Patients ≥ 18 years old
  • Heart transplant recipient
  • Stable clinical situation
  • One or several non-critical coronary stenoses (≥ 50% et ≤ 75% visually or QCA-assessed diameter stenosis) considered as adequate for coronary stenting by the operator
  • Left ventricular ejection fraction ≥ 40%
  • Informed consentement signed by the patient

Exclusion Criteria:

  • Acute coronary syndrome
  • In-stent restenosis
  • Proof of an extensive myocardial ischemia (≥ 7/17 segments ASE model)
  • Coronary stenosis considered as critical by the operators with slow flow

  • ACC/AHA Class IA indication for revascularization :

    • vessel disease with left ventricular dysfunction
    • Left main stenosis
    • Severe proximal LAD stenosis
  • Contra-indication to dual antiplatelet therapy
  • Decompensated heart failure at the time of randomization
  • Pregnant or breast-feeding women- Patients participating to another clinical research within 30 days before randomization- life expectancy < 1 y
  • Patients unable to observe strict medical therapy and follow-up within 1 year after randomization

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: 1: Coronary stent+optimal medical therapy
Coronary stent on top of optimal medical therapy
Enhed: Stent
Coronary revascularization
Andre navne:
  • Any type of approved bare metal or drug-eluting coronary stent
Medicin: optimal medical therapy
Dual antiplatelet therapy: aspirin and a P2Y12 inhibitor as indicated
Andre navne:
  • Any treatment required at the physicians discretion for the treatment of the patient
Aktiv komparator: 2: Optimal medical therapy
Optimal medical therapy
Medicin: optimal medical therapy
Dual antiplatelet therapy: aspirin and a P2Y12 inhibitor as indicated
Andre navne:
  • Any treatment required at the physicians discretion for the treatment of the patient

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The composit of death, myocardial infarction, retransplantation, implantation of transitory or definitive ventricular assist devices, new or worsening heart failure, graft failure and/or a decrease of left ventricular ejection fraction of at least 25%
Tidsramme: at 1 year
The composit of death, myocardial infarction, retransplantation, implantation of transitory or definitive ventricular assist devices, new or worsening heart failure, graft failure and/or a decrease of left ventricular ejection fraction of at least 25% at 1 year
at 1 year

Sekundære resultatmål

Resultatmål
Tidsramme
Death at 1 year
Tidsramme: at 1 year
at 1 year
myocardial infarction at 1 year
Tidsramme: at 1 year
at 1 year
Retransplantation at 1 year
Tidsramme: at 1 year
at 1 year
implantation of transitory or definitive ventricular assist devices at 1 year
Tidsramme: at 1 year
at 1 year
new or worsening heart failure at 1 year
Tidsramme: at 1 year
at 1 year
graft failure and/or a decrease of left ventricular ejection fraction of at least 25% at 1 year compared to baseline
Tidsramme: at 1 year
at 1 year

Samarbejdspartnere og efterforskere

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Efterforskere

  • Studieleder: Farzin BEYGUI, MD, PhD, Assistance Publique - Hôpitaux de Paris
  • Ledende efterforsker: Pascal LEPRINCE, MD, PhD, Assistance Publique - Hôpitaux de Paris
  • Ledende efterforsker: Saida VARNOUS, MD, Assistance Publique - Hôpitaux de Paris

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. februar 2013

Primær færdiggørelse (Faktiske)

1. februar 2015

Studieafslutning (Faktiske)

1. februar 2015

Datoer for studieregistrering

Først indsendt

19. februar 2013

Først indsendt, der opfyldte QC-kriterier

20. februar 2013

Først opslået (Skøn)

21. februar 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

14. oktober 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. oktober 2015

Sidst verificeret

1. oktober 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • P081262
  • 2010-A01516-33 (Anden identifikator: IDRCB)

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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