A Phase 3 interventional study of Stent and optimal medical therapy in Heart-lung Transplant Rejection, sponsored by Assistance Publique - Hôpitaux de Paris. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-10-14.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment
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.
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.
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
ACC/AHA Class IA indication for revascularization :
Coronary stent on top of optimal medical therapy
Device: Stent · Drug: optimal medical therapy
Optimal medical therapy
Drug: optimal medical therapy
Coronary revascularization
Also known as: Any type of approved bare metal or drug-eluting coronary stent
Dual antiplatelet therapy: aspirin and a P2Y12 inhibitor as indicated
Also known as: Any treatment required at the physicians discretion for the treatment of the patient
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%
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
Time frame: at 1 year
Death at 1 year
Time frame: at 1 year
myocardial infarction at 1 year
Time frame: at 1 year
Retransplantation at 1 year
Time frame: at 1 year
implantation of transitory or definitive ventricular assist devices at 1 year
Time frame: at 1 year
new or worsening heart failure at 1 year
Time frame: at 1 year
graft failure and/or a decrease of left ventricular ejection fraction of at least 25% at 1 year compared to baseline
Time frame: at 1 year
This study is terminated, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris