Assessment of Revascularization Versus Conservative Treatment in Heart Transplant Patients for a Clinical Event Reduction (ARCHER)
Assessment of Revascularization Versus Conservative Treatment in Heart Transplant Patients for a Clinical Event Reduction: THE ARCHER TRIAL
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
-
-
-
Paris, Frankrike, 75013
- Pitié Salpetriere university Hospital - Cardiology
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 1: Coronary stent+optimal medical therapy
Coronary stent on top of optimal medical therapy
|
Coronary revascularization
Andre navn:
Dual antiplatelet therapy: aspirin and a P2Y12 inhibitor as indicated
Andre navn:
|
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Aktiv komparator: 2: Optimal medical therapy
Optimal medical therapy
|
Dual antiplatelet therapy: aspirin and a P2Y12 inhibitor as indicated
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studieleder: Farzin BEYGUI, MD, PhD, Assistance Publique - Hôpitaux de Paris
- Hovedetterforsker: Pascal LEPRINCE, MD, PhD, Assistance Publique - Hôpitaux de Paris
- Hovedetterforsker: Saida VARNOUS, MD, Assistance Publique - Hôpitaux de Paris
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- P081262
- 2010-A01516-33 (Annen identifikator: IDRCB)
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