AERIAL Trial: Antiplatelet Therapy in Heart Transplantation

Status Recruiting

Clinical Trial Summary

Cardiac allograft vasculopathy is a common complication affecting heart transplant patients. This condition causes narrowing of the heart arteries leading to graft dysfunction. The research team is investigating whether early antiplatelet therapy post heart transplant can prevent the development of CAV. This study will determine the feasibility of a large multicenter randomized placebo-controlled trial to answer this question.

Clinical Trial Description

Heart transplant patients who fulfill selection criteria will undergo baseline clinical evaluation and data collection. Participants will be randomized to either placebo, aspirin or clopidogrel to be taken daily for the duration of the study. Patients will undergo invasive coronary studies (angiography, optical coherence tomography and intracoronary flow) and platelet function testing at 2 and 12 months post heart transplant. In addition, angiography will be performed at 24 months post heart transplant and thereafter according to institutional protocol. The primary analysis will determine the feasibility of conducting a large multicenter randomized placebo controlled trial by assessing recruitment rates, event rates, treatment crossovers and loss to follow-up. Secondary analyses will include assessing the effect of antiplatelet treatment on angiographic CAV, coronary intimal disease on optical coherence tomography, coronary macrovascular and microvascular function by intracoronary flow measures, and platelet function. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04770012
Study type	Interventional
Source	Ottawa Heart Institute Research Corporation
Contact	Sharon Chih
Phone	613-696-7000
Email	schih@ottawaheart.ca
Status	Recruiting
Phase	Phase 3
Start date	June 28, 2021
Completion date	December 2024

View Details

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