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

NCT01795729 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2015-10-14

No results posted yet for this study

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.

Conditions

  • Heart-lung Transplant Rejection

Interventions

DEVICE

Stent

Coronary revascularization

DRUG

optimal medical therapy

Dual antiplatelet therapy: aspirin and a P2Y12 inhibitor as indicated

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Farzin BEYGUI, MD, PhD · Assistance Publique - Hôpitaux de Paris

  • Pascal LEPRINCE, MD, PhD · Assistance Publique - Hôpitaux de Paris

  • Saida VARNOUS, MD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01795729 on ClinicalTrials.gov