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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01795729
First received: February 19, 2013
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Heart-lung Transplant Rejection
Device: Stent
Drug: optimal medical therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of Revascularization Versus Conservative Treatment in Heart Transplant Patients for a Clinical Event Reduction: THE ARCHER TRIAL

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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% [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Death at 1 year [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
  • myocardial infarction at 1 year [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
  • Retransplantation at 1 year [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
  • implantation of transitory or definitive ventricular assist devices at 1 year [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
  • new or worsening heart failure at 1 year [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: February 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1: Coronary stent+optimal medical therapy
Coronary stent on top of optimal medical therapy
Device: Stent
Coronary revascularization
Other Name: Any type of approved bare metal or drug-eluting coronary stent
Drug: optimal medical therapy
Dual antiplatelet therapy: aspirin and a P2Y12 inhibitor as indicated
Other Name: Any treatment required at the physicians discretion for the treatment of the patient
Active Comparator: 2: Optimal medical therapy
Optimal medical therapy
Drug: optimal medical therapy
Dual antiplatelet therapy: aspirin and a P2Y12 inhibitor as indicated
Other Name: Any treatment required at the physicians discretion for the treatment of the patient

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01795729

Contacts
Contact: Farzin BEYGUI, MD, PhD 33 6 78 88 41 79 Beygui-f@chu-caen.fr

Locations
France
Pitié Salpetriere university Hospital - Cardiology Recruiting
Paris, France, 75013
Contact: Farzin BEYGUI, MD, PhD    33 6 78 88 41 79    Beygui-f@chu-caen.fr   
Principal Investigator: Farzin BEYGUI, MD, PhD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Study Director: Farzin BEYGUI, MD, PhD Assistance Publique - Hôpitaux de Paris
Principal Investigator: Pascal LEPRINCE, MD, PhD Assistance Publique - Hôpitaux de Paris
Principal Investigator: Saida VARNOUS, MD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01795729     History of Changes
Other Study ID Numbers: P081262, 2010-A01516-33
Study First Received: February 19, 2013
Last Updated: February 17, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Heart transplant
Coronary artery disease
Allograft vascular disease
Coronary stent
Optimal medical therapy
Prognosis

ClinicalTrials.gov processed this record on September 30, 2014