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

NCT ID: NCT01795729

Last Updated: 2015-10-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2015-02-28

Brief Summary

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.

Detailed Description

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.

Conditions

Heart-lung Transplant Rejection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1: Coronary stent+optimal medical therapy

Coronary stent on top of optimal medical therapy

Group Type: EXPERIMENTAL

Stent

Intervention Type: DEVICE

Coronary revascularization

optimal medical therapy

Intervention Type: DRUG

Dual antiplatelet therapy: aspirin and a P2Y12 inhibitor as indicated

2: Optimal medical therapy

Optimal medical therapy

Group Type: ACTIVE_COMPARATOR

optimal medical therapy

Intervention Type: DRUG

Dual antiplatelet therapy: aspirin and a P2Y12 inhibitor as indicated

Interventions

Stent

Coronary revascularization

Intervention Type: DEVICE

optimal medical therapy

Dual antiplatelet therapy: aspirin and a P2Y12 inhibitor as indicated

Intervention Type: DRUG

Other Intervention Names

Any type of approved bare metal or drug-eluting coronary stent; Any treatment required at the physicians discretion for the treatment of the patient

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Farzin BEYGUI, MD, PhD

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Pascal LEPRINCE, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Saida VARNOUS, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Pitié Salpetriere university Hospital - Cardiology

Paris, , France

Countries

France

Other Identifiers

2010-A01516-33

Identifier Type: OTHER

Identifier Source: secondary_id

P081262

Identifier Type: -

Identifier Source: org_study_id