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

Heart-lung Transplant Rejection Clinical Trial

— ARCHER  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01795729
• Other study ID #: P081262
• Secondary ID: 2010-A01516-33
• Status: Terminated
• Phase: Phase 3
• First received: February 19, 2013
• Last updated: October 13, 2015
• Start date: February 2013
• Est. completion date: February 2015

Study information

• Verified date: October 2015
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart-lung Transplant Rejection

Intervention

Device:
• Stent
Coronary revascularization

Drug:
• optimal medical therapy
Dual antiplatelet therapy: aspirin and a P2Y12 inhibitor as indicated

Locations

Country	Name	City	State
France	Pitié Salpetriere university Hospital - Cardiology	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	at 1 year	No
Secondary	Death at 1 year		at 1 year	No
Secondary	myocardial infarction at 1 year		at 1 year	No
Secondary	Retransplantation at 1 year		at 1 year	No
Secondary	implantation of transitory or definitive ventricular assist devices at 1 year		at 1 year	No
Secondary	new or worsening heart failure at 1 year		at 1 year	No
Secondary	graft failure and/or a decrease of left ventricular ejection fraction of at least 25% at 1 year compared to baseline		at 1 year	No